Combination administration of gamma globulin and hyaluronidases to determine injection times

Abstract

The present disclosure provides a method of determining one or more parameters of an injection of a formulation in a human subject, the method comprising: administering to an animal subject via subcutaneous injection from a high volume autoinjector about 3 mL to about 50 mL of a formulation comprising a therapeutically effective amount of a hyaluronidase enzyme; measuring one or more parameters of the subcutaneous injection in the animal subject; and determining the same one or more parameters of the subcutaneous injection in the human subject from the one or more measured parameters from the animal subject; wherein the one or more parameters are selected from injection time, injection force, and injection site reaction data.

Description

[0001]COMBINATION ADMINISTRATION OF GAMMA GLOBULIN AND HYALURONIDASES TO DETERMINE INJECTION TIMES FIELD OF THE INVENTION The inventions herein relate to compositions and combination dosing regimen comprising administering gamma globulin and hyaluronidase to assess clinical injection times. CROSS-REFERENCE TO RELATED APPLICATIONS The present International application claims priority to U.S. Provisional Patent Application No.63 / 573,391, filed April 2, 2024, and U.S. Provisional Patent Application No. 63 / 691,488, filed September 6, 2024, each of which are incorporated herein by reference in their entirety. INCORPORATION BY REFERENCE OF SEQUENCE LISTING An electronic version of the Sequence Listing is filed herewith, the contents of which are incorporated by reference in their entirety. The electronic file was created on March 31, 2025, is 101 kilobytes in size, and is titled 063995-5125WO.xml. BACKGROUND Patient surveys have shown that the majority of patients would prefer to receive a long- acting injectable regimen at fewer intervals rather than taking intravenous injections. Long-acting injectable treatments are limited by patient experience and side effects. Achieving an injectable suspension with a high concentration of biological agent in order to dose less frequently and overcome the non-compliance problem with treatment regimens, whilst maintaining product stability, and avoiding patient side effects is desirable. SUMMARY OF THE DISCLOSURE In one aspect, the present disclosure provides a method of determining one or more parameters of an injection of a formulation in a human subject, the method comprising: administering to an animal subject via subcutaneous injection from a high volume autoinjector about 3 mL to about 50 mL of a formulation comprising a therapeutically effective amount of a hyaluronidase enzyme; measuring one or more parameters of the subcutaneous injection in the animal subject; and determining the same one or more parameters of the subcutaneous injection in the human subject from the one or more measured parameters from the animal subject; wherein the one or more parameters are selected from injection time, injection force, and DB1 / 155561236.2 1 injection site reaction data. In one embodiment, the hyaluronidase enzyme is a soluble hyaluronidase enzyme. In one embodiment, the hyaluronidase enzyme is a recombinant human hyaluronidase enzyme. In one embodiment, the hyaluronidase enzyme is a recombinant human hyaluronidase PH20 enzyme. In one embodiment, the recombinant human hyaluronidase PH20 enzyme comprises a sequence having at least 95% amino acid sequence identity to an amino acid sequence of SEQ ID NO: 1. In one embodiment, the formulation further comprises a therapeutically effective amount of an active ingredient selected from a small molecule, a protein, a peptide fragment, a biologic, a nanoparticle, an antibody, an antibody fragment, and a small molecule antiviral. In one embodiment, the antibody comprises a monoclonal antibody or a polyclonal antibody. In one embodiment, the monoclonal antibody or the polyclonal antibody comprises trastuzumab, rituximab, pertuzumab, atezolizumab, immune globulin, daratumumab, efgartigimod alfa, nivolumab, or ocrelizumab. In one embodiment, the protein comprises gamma globulin. In one embodiment, the animal subject is a miniature pig. In one embodiment, the animal subject is a Yucatan miniature pig. In one embodiment, the method comprises administering about 10 mL to about 20 mL of the formulation to the animal subject. In one embodiment, the method comprises administering about 10 mL to about 20 mL of the formulation to the human subject. In one embodiment, the method comprises administering about 3 mL to about 15 mL of the formulation to the animal subject. In one embodiment, the method comprises administering about 3 mL to about 15 mL of the formulation to the human subject. In one embodiment, the method comprises administering about 3 mL, about 3.1 mL, about 3.2 mL, about 3.4 mL, about 3.5 mL, about 3.6 mL, about 3.7 mL, about 3.8 mL, about 3.9 mL, about 4 mL, about 4.1 mL, about 4.2 mL, about 4.3 mL, about 4.4 mL, about 4.5 mL, about 5 mL, about 5.1 mL, about 5.2 mL, about 5.3 mL, about 5.4 mL, about 5.5 mL, about 5.6 mL, about 5.7 mL, about 5.8 mL, about 5.9 mL, about 6 mL, about 6.1 mL, about 6.2 mL, about 6.3 mL, about 6.4 mL, about 6.5 mL, about 6.6 mL, about 6.7 mL, about 6.8 mL, about 6.9 mL, about 7 mL, about 7.1 mL, about 7.2 mL, about 7.3 mL about 7.4 mL, about 7.5 mL, about 7.6 mL, about 7.7 mL, about 7.8 mL, about 7.9 mL, about 8 mL, about 8.1 mL, about 8.2 mL, about 8.3 mL, about 8.4 mL, about 8.5 mL, about 8.6 mL, about 8.7 mL, about 8.8 mL, about 8.9 mL, about 9 mL, about 9.1 mL, about 9.2 mL, about 9.3 mL, about 9.4 mL, about 9.5 mL, about 9.6 mL, about 9.7 mL, about 9.8 mL, about 9.9 mL, about 10 mL, about 10.1 mL, about 10.2 mL, about 10.3 mL, about 10.4 mL, about 10.5 mL, about 10.6 mL, about 10.7 mL, about 10.8 mL, about 10.9 mL, about 11 mL, about 11.1 mL, about 11.2 mL, about 11.3 mL, about 11.4 mL, about 11.5 mL, about 11.6 mL, about 11.7 mL, about 11.8 mL, about 11.9 mL, about 12 mL, about 12.1 mL, about 12.2 mL, about 12.3 mL, about 12.4 mL, about 12.5 mL, about 12.6 mL, DB1 / 155561236.2 2 about 12.7 mL, about 12.8 mL, about 12.9 mL, about 13 mL, about 13.1 mL, about 13.2 mL, about 13.3 mL, about 13.4 mL, about 13.5 mL, about 13.6 mL, about 13.7 mL, about 13.8 mL, about 13.9 mL, about 14 mL, about 14.1 mL, about 14.2 mL, about 14.3 mL, about 14.4 mL, about 14.5 mL, about 14.6 mL, about 14.7 mL, about 14.8 mL, about 14.9 mL, about 15 mL, about 15.1 mL, about 15.2 mL, about 15.3 mL, about 15.4 mL, about 15.5 mL, about 15.6 mL, about 15.7 mL, about 15.8 mL, about 15.9 mL, about 16 mL, about 16.1 mL, about 16.2 mL, about 16.3 mL, about 16.4 mL, about 16.5 mL, about 16.6 mL, about 16.7 mL, about 16.8 mL, about 16.9 mL about 17 mL, about 17.1 mL, about 17.2 mL, about 17.3 mL, about 17.4 mL, about 17.5 mL, about 17.6 mL, about 17.7 mL, about 17.8 mL, about 17.9 mL, about 18 mL, about 18.1 mL, about 18.2 mL, about 18.3 mL, about 18.4 mL, about 18.5 mL, about 18.6 mL, about 18.7 mL, about 18.8 mL, about 18.9 mL, about 19 mL, about 19.1 mL, about 19.2 mL, about 19.3 mL, about 19.4 mL, about 19.5 mL, about 19.6 mL, about 19.7 mL, about 19.8 mL, about 19.9 mL, about 20 mL, about 20.1 mL, about 20.2 mL, about 20.3 mL, about 20.4 mL, about 20.5 mL, about 20.6 mL, about 20.7 mL, about 20.8 mL, about 20.9 mL, about 21 mL, about 21.1 mL, about 21.2 mL, about 21.3 mL, about 21.4 mL, about 21.5 mL, about 21.6 mL, about 21.7 mL, about 21.8 mL, about 21.9 mL, about 22 mL, about 22.1 mL, about 22.2 mL, about 22.3 mL, about 22.4 mL, about 22.5 mL, about 22.6 mL, about 22.7 mL, about 22.8 mL, about 22.9 mL, about 23 mL, about 23.1 mL, about 23.2 mL, about 23.3 mL, about 23.4 mL, about 23.5 mL, about 23.6 mL, about 23.7 mL, about 23.8 mL, about 23.9 mL, about 24 mL, about 24.1 mL, about 24.2 mL, about 24.3 mL, about 24.4 mL, about 24.5 mL, about 24.6 mL, about 24.7 mL, about 24.8 mL, about 24.9 mL, or about 25 mL to the animal subject. In one embodiment, the method comprises administering about 3 mL, about 3.1 mL, about 3.2 mL, about 3.4 mL, about 3.5 mL, about 3.6 mL, about 3.7 mL, about 3.8 mL, about 3.9 mL, about 4 mL, about 4.1 mL, about 4.2 mL, about 4.3 mL, about 4.4 mL, about 4.5 mL, about 5 mL, about 5.1 mL, about 5.2 mL, about 5.3 mL, about 5.4 mL, about 5.5 mL, about 5.6 mL, about 5.7 mL, about 5.8 mL, about 5.9 mL, about 6 mL, about 6.1 mL, about 6.2 mL, about 6.3 mL, about 6.4 mL, about 6.5 mL, about 6.6 mL, about 6.7 mL, about 6.8 mL, about 6.9 mL, about 7 mL, about 7.1 mL, about 7.2 mL, about 7.3 mL about 7.4 mL, about 7.5 mL, about 7.6 mL, about 7.7 mL, about 7.8 mL, about 7.9 mL, about 8 mL, about 8.1 mL, about 8.2 mL, about 8.3 mL, about 8.4 mL, about 8.5 mL, about 8.6 mL, about 8.7 mL, about 8.8 mL, about 8.9 mL, about 9 mL, about 9.1 mL, about 9.2 mL, about 9.3 mL, about 9.4 mL, about 9.5 mL, about 9.6 mL, about 9.7 mL, about 9.8 mL, about 9.9 mL, about 10 mL, about 10.1 mL, about 10.2 mL, about 10.3 mL, about 10.4 mL, about 10.5 mL, about 10.6 mL, about 10.7 mL, about 10.8 mL, about 10.9 mL, about 11 mL, about 11.1 mL, about 11.2 mL, about 11.3 mL, about 11.4 mL, about 11.5 mL, about DB1 / 155561236.2 3 11.6 mL, about 11.7 mL, about 11.8 mL, about 11.9 mL, about 12 mL, about 12.1 mL, about 12.2 mL, about 12.3 mL, about 12.4 mL, about 12.5 mL, about 12.6 mL, about 12.7 mL, about 12.8 mL, about 12.9 mL, about 13 mL, about 13.1 mL, about 13.2 mL, about 13.3 mL, about 13.4 mL, about 13.5 mL, about 13.6 mL, about 13.7 mL, about 13.8 mL, about 13.9 mL, about 14 mL, about 14.1 mL, about 14.2 mL, about 14.3 mL, about 14.4 mL, about 14.5 mL, about 14.6 mL, about 14.7 mL, about 14.8 mL, about 14.9 mL, about 15 mL, about 15.1 mL, about 15.2 mL, about 15.3 mL, about 15.4 mL, about 15.5 mL, about 15.6 mL, about 15.7 mL, about 15.8 mL, about 15.9 mL, about 16 mL, about 16.1 mL, about 16.2 mL, about 16.3 mL, about 16.4 mL, about 16.5 mL, about 16.6 mL, about 16.7 mL, about 16.8 mL, about 16.9 mL about 17 mL, about 17.1 mL, about 17.2 mL, about 17.3 mL, about 17.4 mL, about 17.5 mL, about 17.6 mL, about 17.7 mL, about 17.8 mL, about 17.9 mL, about 18 mL, about 18.1 mL, about 18.2 mL, about 18.3 mL, about 18.4 mL, about 18.5 mL, about 18.6 mL, about 18.7 mL, about 18.8 mL, about 18.9 mL, about 19 mL, about 19.1 mL, about 19.2 mL, about 19.3 mL, about 19.4 mL, about 19.5 mL, about 19.6 mL, about 19.7 mL, about 19.8 mL, about 19.9 mL, about 20 mL, about 20.1 mL, about 20.2 mL, about 20.3 mL, about 20.4 mL, about 20.5 mL, about 20.6 mL, about 20.7 mL, about 20.8 mL, about 20.9 mL, about 21 mL, about 21.1 mL, about 21.2 mL, about 21.3 mL, about 21.4 mL, about 21.5 mL, about 21.6 mL, about 21.7 mL, about 21.8 mL, about 21.9 mL, about 22 mL, about 22.1 mL, about 22.2 mL, about 22.3 mL, about 22.4 mL, about 22.5 mL, about 22.6 mL, about 22.7 mL, about 22.8 mL, about 22.9 mL, about 23 mL, about 23.1 mL, about 23.2 mL, about 23.3 mL, about 23.4 mL, about 23.5 mL, about 23.6 mL, about 23.7 mL, about 23.8 mL, about 23.9 mL, about 24 mL, about 24.1 mL, about 24.2 mL, about 24.3 mL, about 24.4 mL, about 24.5 mL, about 24.6 mL, about 24.7 mL, about 24.8 mL, about 24.9 mL, or about 25 mL to the human subject. In one embodiment, the formulation is in a prefilled syringe. In one embodiment, the prefilled syringe contains about 3 mL, about 3.1 mL, about 3.2 mL, about 3.4 mL, about 3.5 mL, about 3.6 mL, about 3.7 mL, about 3.8 mL, about 3.9 mL, about 4 mL, about 4.1 mL, about 4.2 mL, about 4.3 mL, about 4.4 mL, about 4.5 mL, about 5 mL, about 5.1 mL, about 5.2 mL, about 5.3 mL, about 5.4 mL, about 5.5 mL, about 5.6 mL, about 5.7 mL, about 5.8 mL, about 5.9 mL, about 6 mL, about 6.1 mL, about 6.2 mL, about 6.3 mL, about 6.4 mL, about 6.5 mL, about 6.6 mL, about 6.7 mL, about 6.8 mL, about 6.9 mL, about 7 mL, about 7.1 mL, about 7.2 mL, about 7.3 mL about 7.4 mL, about 7.5 mL, about 7.6 mL, about 7.7 mL, about 7.8 mL, about 7.9 mL, about 8 mL, about 8.1 mL, about 8.2 mL, about 8.3 mL, about 8.4 mL, about 8.5 mL, about 8.6 mL, about 8.7 mL, about 8.8 mL, about 8.9 mL, about 9 mL, about 9.1 mL, about 9.2 mL, about 9.3 mL, about 9.4 mL, about 9.5 mL, about 9.6 mL, about 9.7 mL, about 9.8 mL, about 9.9 mL, about 10 mL, about 10.1 mL, about 10.2 DB1 / 155561236.2 4 mL, about 10.3 mL, about 10.4 mL, about 10.5 mL, about 10.6 mL, about 10.7 mL, about 10.8 mL, about 10.9 mL, about 11 mL, about 11.1 mL, about 11.2 mL, about 11.3 mL, about 11.4 mL, about 11.5 mL, about 11.6 mL, about 11.7 mL, about 11.8 mL, about 11.9 mL, about 12 mL, about 12.1 mL, about 12.2 mL, about 12.3 mL, about 12.4 mL, about 12.5 mL, about 12.6 mL, about 12.7 mL, about 12.8 mL, about 12.9 mL, about 13 mL, about 13.1 mL, about 13.2 mL, about 13.3 mL, about 13.4 mL, about 13.5 mL, about 13.6 mL, about 13.7 mL, about 13.8 mL, about 13.9 mL, about 14 mL, about 14.1 mL, about 14.2 mL, about 14.3 mL, about 14.4 mL, about 14.5 mL, about 14.6 mL, about 14.7 mL, about 14.8 mL, about 14.9 mL, about 15 mL, about 15.1 mL, about 15.2 mL, about 15.3 mL, about 15.4 mL, about 15.5 mL, about 15.6 mL, about 15.7 mL, about 15.8 mL, about 15.9 mL, about 16 mL, about 16.1 mL, about 16.2 mL, about 16.3 mL, about 16.4 mL, about 16.5 mL, about 16.6 mL, about 16.7 mL, about 16.8 mL, about 16.9 mL about 17 mL, about 17.1 mL, about 17.2 mL, about 17.3 mL, about 17.4 mL, about 17.5 mL, about 17.6 mL, about 17.7 mL, about 17.8 mL, about 17.9 mL, about 18 mL, about 18.1 mL, about 18.2 mL, about 18.3 mL, about 18.4 mL, about 18.5 mL, about 18.6 mL, about 18.7 mL, about 18.8 mL, about 18.9 mL, about 19 mL, about 19.1 mL, about 19.2 mL, about 19.3 mL, about 19.4 mL, about 19.5 mL, about 19.6 mL, about 19.7 mL, about 19.8 mL, about 19.9 mL, about 20 mL, about 20.1 mL, about 20.2 mL, about 20.3 mL, about 20.4 mL, about 20.5 mL, about 20.6 mL, about 20.7 mL, about 20.8 mL, about 20.9 mL, about 21 mL, about 21.1 mL, about 21.2 mL, about 21.3 mL, about 21.4 mL, about 21.5 mL, about 21.6 mL, about 21.7 mL, about 21.8 mL, about 21.9 mL, about 22 mL, about 22.1 mL, about 22.2 mL, about 22.3 mL, about 22.4 mL, about 22.5 mL, about 22.6 mL, about 22.7 mL, about 22.8 mL, about 22.9 mL, about 23 mL, about 23.1 mL, about 23.2 mL, about 23.3 mL, about 23.4 mL, about 23.5 mL, about 23.6 mL, about 23.7 mL, about 23.8 mL, about 23.9 mL, about 24 mL, about 24.1 mL, about 24.2 mL, about 24.3 mL, about 24.4 mL, about 24.5 mL, about 24.6 mL, about 24.7 mL, about 24.8 mL, about 24.9 mL, or about 25 mL of the formulation. In one embodiment, the prefilled syringe comprises a needle having a gauge of about 20 to about 33. In one embodiment, the prefilled syringe comprises a 20 gauge needle, a 21 gauge needle, a 22 gauge needle, a 23 gauge needle, a 24 gauge needle, a 25 gauge needle, a 26 gauge needle, a 27 gauge needle, a 28 gauge needle, a 29 gauge needle, a 30 gauge needle, a 31 gauge needle, a 32 gauge needle, or a 33 gauge needle. In one embodiment, the method comprises administering the formulation to the animal subject at a rate of about 0.08 mL / sec to about 1.00 mL / sec. In one embodiment, the method comprises administering the formulation to the human subject at a rate of about 0.08 mL / sec to about 1.00 mL / sec. In one embodiment, the method comprises administering the formulation to the animal subject at a rate of at least about 0.08 mL / sec to DB1 / 155561236.2 5 about 1.0 mL / sec. In one embodiment, the method comprises administering the formulation to the human subject at a rate of at least about 0.08 mL / sec to about 1.0 mL / sec. In one embodiment, the method comprises administering the formulation to the animal subject at a rate of at least or faster than about 0.08 mL / sec to about 1.00 mL / sec. In one embodiment, the method comprises administering the formulation to the human subject at a rate of at least or faster than about 0.08 mL / sec to about 1.00 mL / sec. In one embodiment, administering the formulation to the animal subject takes about 10 seconds to about 40 seconds. In one embodiment, administering the formulation to the human subject takes about 10 seconds to about 40 seconds. In one embodiment, administering the formulation to the animal subject takes at least about 10 seconds to about 40 seconds. In one embodiment, administering the formulation to the human subject takes at least about 10 seconds to about 40 seconds. In one embodiment, administering the formulation to the animal subject takes at least or less than about 10 seconds to about 40 seconds. In one embodiment, administering the formulation to the human subject takes at least or less than about 10 seconds to about 40 seconds. In one embodiment, administering the formulation to the animal subject takes about 15 seconds to about 30 seconds. In one embodiment, administering the formulation to the human subject takes about 15 seconds to about 30 seconds. In one embodiment, administering the formulation to the animal subject takes at least about 15 seconds to about 30 seconds. In one embodiment, administering the formulation to the human subject takes at least about 15 seconds to about 30 seconds. In one embodiment, administering the formulation to the animal subject takes at least or less than about 15 seconds to about 30 seconds. In one embodiment, administering the formulation to the human subject takes at least or less than about 15 seconds to about 30 seconds. In one embodiment, the method comprises administering about 10 mL of the formulation to the animal subject at a rate of about 0.32 mL / sec to about 0.42 mL / sec. In one embodiment, the method comprises administering about 10 mL of the formulation to the human subject at a rate of about 0.32 mL / sec to about 0.42 mL / sec. In one aspect, the present disclosure provides a method of determining one or more parameters of an injection of a formulation in a human subject, the method comprising: administering to an animal subject via subcutaneous injection from a high volume autoinjector about 3 mL to about 50 mL of a formulation comprising a therapeutically effective amount of a hyaluronidase enzyme; measuring one or more parameters of the subcutaneous injection in the animal subject; and determining the same one or more parameters of the subcutaneous injection in the human subject from the one or more measured parameters from the animal subject; wherein the one or more parameters is injection force. In one embodiment, the animal subject is DB1 / 155561236.2 6 a miniature pig. In one embodiment, the animal subject is a Yucatan miniature pig. In one embodiment, the formulation further comprises gamma globulin. In one embodiment, the subcutaneous administration to the animal subject occurs via a high volume autoinjector fitted with a 25 gauge needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. In one embodiment, the subcutaneous administration to the human subject occurs via a high volume autoinjector fitted with a 25 gauge needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. In one embodiment, the method comprises determining the injection force of the subcutaneous injection in the human subject by multiplying the measured injection force of the animal subject by a scaling factor. In one embodiment, the scaling factor is about 0.80 to about 0.99. In one embodiment, the scaling factor is about 0.85 to about 0.95; optionally about 0.88 to about 0.92. In one embodiment, the injection force is measured in Newtons (N). In one embodiment, the method comprises: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.42 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the injection force of the subcutaneous injection in the miniature pig to be about 25 N to about 50 N; and determining the injection force of an identical subcutaneous injection in the human subject by multiplying the miniature pig injection force by a scaling factor of about 0.85 to about 0.95, obtaining an estimated injection force of about 21 N to about 48 N. In one embodiment, the method comprises: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.36 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the injection force of the subcutaneous injection in the miniature pig to be about 40 N to about 46 N; and determining the injection force of an identical subcutaneous injection in the human subject by multiplying the miniature pig injection force by a scaling factor of about 0.88 to about 0.92, obtaining an estimated injection force of about 35 N to about 42 N. In one embodiment, the subcutaneous administration to the animal subject comprises a single injection. In one embodiment, the subcutaneous administration to the human subject comprises a single injection. In one embodiment, the subcutaneous administration to the animal subject comprises two or more injections. In one embodiment, the subcutaneous administration to the human subject comprises two or more injections. In one aspect, the present disclosure provides a method of determining one or more parameters of an injection of a formulation in a human subject, the method comprising: DB1 / 155561236.2 7 administering to an animal subject via subcutaneous injection from a high volume autoinjector about 3 mL to about 50 mL of a formulation comprising a therapeutically effective amount of a hyaluronidase enzyme; measuring one or more parameters of the subcutaneous injection in the animal subject; and determining the same one or more parameters of the subcutaneous injection in the human subject from the one or more measured parameters from the animal subject; wherein the one or more parameters is injection time. In one embodiment, the animal subject is a miniature pig. In one embodiment, the animal subject is a Yucatan miniature pig. In one embodiment, the formulation further comprises gamma globulin. In one embodiment, the subcutaneous administration to the animal subject occurs via a high volume autoinjector fitted with a 25 gauge needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. In one embodiment, the subcutaneous administration to the human subject occurs via a high volume autoinjector fitted with a 25 gauge needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. In one embodiment, the method comprises determining the injection time of the subcutaneous injection in the human subject by multiplying the measured injection time of the animal subject by a scaling factor. In one embodiment, the scaling factor is about 0.80 to about 0.99. In one embodiment, the scaling factor is about 0.85 to about 0.95; optionally about 0.88 to about 0.92. In one embodiment, the injection time is measured in seconds. In one embodiment, the method comprises: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.36 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the injection time of the subcutaneous injection in the miniature pig to be about 15 seconds to about 35 seconds; and determining the injection time of an identical subcutaneous injection in the human subject by multiplying the miniature pig injection time by a scaling factor of about 0.85 to about 0.95, obtaining an estimated injection time of about 13 seconds to about 33 seconds. In one embodiment, the method comprises: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.36 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the injection time of the subcutaneous injection in the miniature pig to be about 18 seconds to about 30 seconds; and determining the injection time of an identical subcutaneous injection in the human subject by multiplying the miniature pig injection time by a scaling factor of about 0.88 to about 0.92, obtaining an estimated injection time of about 16 seconds to about 28 seconds. In one embodiment, the subcutaneous DB1 / 155561236.2 8 administration to the animal subject comprises a single injection. In one embodiment, the subcutaneous administration to the human subject comprises a single injection. In one embodiment, the subcutaneous administration to the animal subject comprises two or more injections. In one embodiment, the subcutaneous administration to the human subject comprises two or more injections. In one aspect, the present disclosure provides a method of determining one or more parameters of an injection of a formulation in a human subject, the method comprising: administering to an animal subject via subcutaneous injection from a high volume autoinjector about 3 mL to about 50 mL of a formulation comprising a therapeutically effective amount of a hyaluronidase enzyme; measuring one or more parameters of the subcutaneous injection in the animal subject; and determining the same one or more parameters of the subcutaneous injection in the human subject from the one or more measured parameters from the animal subject; wherein the one or more parameters is injection site reaction data. In one embodiment, the injection site reaction data comprises one or more of back leakage at the injection site, swelling volume at the injection site, swelling height at the injection site, bleb swelling size at the injection site, bleb induration at the injection site, and bleb resolution at the injection site. In one embodiment, the animal subject is a miniature pig. In one embodiment, the animal subject is a Yucatan miniature pig. In one embodiment, the formulation further comprises gamma globulin. In one embodiment, the subcutaneous administration to the animal subject occurs via a high volume autoinjector fitted with a 25 gauge needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. In one embodiment, the subcutaneous administration to the human subject occurs via a high volume autoinjector fitted with a 25 gauge needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. In one embodiment, the method comprises: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.42 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the one or more injection site reactions of the subcutaneous injection in the miniature pig and assigning a score from 0, 1, 2, 3, or 4; and determining that the one or more injection site reactions of an identical subcutaneous injection in the human subject will have the same score. In one embodiment, the method comprises: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.36 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the DB1 / 155561236.2 9 one or more injection site reactions of the subcutaneous injection in the miniature pig and assigning a score from 0, 1, 2, 3, or 4; and determining that the one or more injection site reactions of an identical subcutaneous injection in the human subject will have the same score. In one embodiment, the subcutaneous administration to the animal subject comprises a single injection. In one embodiment, the subcutaneous administration to the human subject comprises a single injection. In one embodiment, the subcutaneous administration to the animal subject comprises two or more injections. In one embodiment, the subcutaneous administration to the human subject comprises two or more injections. DESCRIPTION OF THE FIGURES FIGS.1A-1B contain data with different needle gauges for the injection of 10 mL of GGL + rHuPH20 in mini-pigs. The needle gauge selection was used to control injection times. FIG.1A contains data obtained using a syringe pump. FIG.1B contains data obtained using an HVAI. FIG.2 provides data from a human study demonstrating that the mini-pig model may predict human injection times for HVAI. The data was obtained from a study of humans (Part B) injected with 10 mL over 30 seconds. FIGS.3A-3B contain data demonstrating that the mini-pig model can estimate injection site reactions for HVAI. FIG.3A provides the mini-pig injection site reaction data. FIG.3B provides the human injection site reaction data. DETAILED DESCRIPTION Provided are combination dosing regimens, comprising administering hyaluronidase; and administering a gamma globulin to assess the clinical injection times of a 10 ml high-volume auto-injector (HVAI) with recombinant human hyaluronidase (rHuPH20). A. Definitions Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of skill in the art to which the invention(s) belong. All patents, patent applications, published applications and publications, GenBank®sequences, databases, websites and other published materials referred to throughout the entire disclosure herein, unless noted otherwise, are incorporated by reference in their entirety. If there are a plurality of definitions for terms herein, those in this section prevail. Where reference is made to a URL or other such identifier or address, it is understood that such identifiers can change and DB1 / 155561236.2 10 particular information on the internet can come and go, but equivalent information can be found by searching the internet. Reference thereto evidences the availability and public dissemination of such information. As used herein the term ‘combination dosing regimen’ refers to at least two components administered together to a patient. As used herein, the term ‘treatment’ or ‘treating’ refers to alleviating the specified condition, eliminating or reducing the symptoms of the condition, slowing or eliminating the progression, invasion, or spread of the condition and reducing or delaying the reoccurrence of the condition in a previously afflicted subject. As used herein, the term ‘prevention’ or ‘preventing’ refers to precluding developing a disease, disorder, or condition or reducing the risk of developing the disease, disorder, or condition or reducing the symptoms thereof. As used herein the term ‘injection site reaction’ means side effects at or near the spot where the infusion / injection was received. This includes pain or discomfort, redness, swelling, itching, bruising, lumps, infection complications (cellulitis or abscess), and irritation. As used herein, a soluble hyaluronidase is a hyaluronidase of form thereof that is not GPI anchored, and that is soluble under physiological conditions and is secreted upon expression. Hyaluronidases, such as ovine and bovine hyaluronidases occur as soluble hyaluronidases. Human PH20 hyaluronidase does not occur as a soluble hyaluronidase. It is known in the art that removal of all or a part of the GPI anchor results in soluble forms. As used herein the term ‘rHuPH20’ refers to the soluble hyaluronidase composition produced upon expression in a mammalian cell, such as a CHO cell, or other cell that effects glycosylation, of nucleic acid encoding residues 36-482 of SEQ ID NO: 1. For expression in cells the encoding nucleic acid is linked to the native (residues 1-35 of SEQ ID NO: 1) or a heterologous signal sequence for trafficking and secretion of the encoded polypeptides. The resulting secreted soluble glycoprotein is a heterogeneous mixture of polypeptides, including polypeptides that terminate at residues 479, 480, 481, and 482, and are composed of residues 36- 479, 36-480, 36-481, and 36-482 with reference to SEQ ID NO: 1. Shorter C-terminally truncated forms also may be included. As used herein, “combination therapy” refers to a treatment in which a subject if given two or more therapeutic agents, such as at least two or at least three therapeutic agents, for treating a single disease. DB1 / 155561236.2 11 As used herein, “hyaluronidase activity” refers to the ability to enzymatically catalyse the cleavage of hyaluronic acid. The United States Pharmacopeia (USP) XXII assay for hyaluronidase determines hyaluronidase activity indirectly by measuring the amount of higher molecular weight hyaluronic acid, or hyaluronan, (HA) substrate remaining after the enzyme is allowed to react with the HA for 30 min at 37 °C (USP XXII-NF XVII (1990) 644-645 United States Pharmacopeia Convention, Inc, Rockville, MD). A Reference Standard solution can be used in an assay to ascertain the relative activity, in units, of any hyaluronidase. In vitro assays to determine the hyaluronidase activity of hyaluronidases, such as PH20, including soluble PH20 and esPH20, are known in the art and described herein. Exemplary assays include the micro turbidity assay that measures cleavage of hyaluronic acid by hyaluronidase indirectly by detecting the insoluble precipitate formed when the uncleaved hyaluronic acid binds with serum albumin and the biotinylated-hyaluronic acid assay that measures the cleavage of hyaluronic acid indirectly by detecting the remaining biotinylated-hyaluronic acid non-covalently bound to microtiter plate wells with a streptavidin-horseradish peroxidase conjugate and a chromogenic substrate. Reference Standards can be used, for example, to generate a standard curve to determine the activity in Units of the hyaluronidase being tested. As used herein, specific activity refers to Units of activity per mg protein. The milligrams of hyaluronidase is defined by the absorption of a solution of at 280 nm assuming a molar extinction coefficient of approximately 1.7, in units of M-1 cm-1. As used herein, “neutral active” refers to the ability of a PH20 polypeptide to enzymatically catalyse the cleavage of hyaluronic acid at neutral pH (e.g. at or about pH 7.0). The term “antibody” is used in the broadest sense and specifically includes monoclonal antibodies (including full length monoclonal antibodies), multi-specific antibodies (e.g. bispecific antibodies), and antibody fragments that exhibit a desired biological activity or function. An antibody generally comprises two heavy chains and two light chains, each comprising a variable domain and a constant domain. Each variable domain contains a hypervariable region containing three complementarity determining regions (CDR) flanked by four segments of the framework region. As used herein, the “framework region” contains all four segments FR1, FR2, FR3, and FR4 that flank a set of three hypervariable regions. Antibodies can be chimeric, humanized, or human, for example, and can be antigen- binding fragments of these. Antibodies are generally produced by immunizing an animal with an DB1 / 155561236.2 12 antigen, and can be produced by recombinant technology, or by synthesis of the amino acid sequence, for example. “Antibody fragments” comprise a portion of a full-length antibody, generally the antigen binding or variable region thereof. Examples of antibody fragments include Fab, Fab′, F(ab′)2 and Fv fragments; diabodies; linear antibodies; single-chain antibody molecules; and multispecific antibodies such as bispecific antibodies, for example formed from antibody fragments. “Functional fragments” substantially retain binding to an antigen of the full- length antibody and retain a biological activity. As used herein, “monoclonal antibody” as refers to an antibody obtained from a population of substantially homogeneous antibodies, i.e. the individual antibodies of the population are identical except for possible naturally occurring mutations that may be present in minor amounts. Monoclonal antibodies are highly specific, being directed against a single antigenic site. Furthermore, in contrast to conventional (polyclonal) antibody preparations that typically include different antibodies directed against different determinants (epitopes), each monoclonal antibody is directed against a single determinant on the antigen. The modifier “monoclonal” indicates the character of the antibody as being obtained from a substantially homogeneous population of antibodies and is not to be construed as requiring production of the antibody by any particular method. For example, monoclonal antibodies may be made by the hybridoma method first described by Kohler (1975), Nature 256:495, or may be made by recombinant DNA methods (see, e.g., U.S. Patent No.4,816,567). The “monoclonal antibodies” may also be isolated from phage antibody libraries. As used herein, “polyclonal antibody” as refers to a mixture of immunoglobulin molecules that are secreted against a particular antigen. Polyclonal antibodies are produced by different clones of plasma B cells leading to a heterogeneous antibody population that interact with different epitopes on the same antigen. As used herein, a “GPI-anchor attachment signal sequence” is a C-terminal sequence of amino acids that directs addition of a preformed GPI-anchor to the polypeptide within the lumen of the ER. GPI-anchor attachment signal sequences are present in the precursor polypeptides of GPI-anchored polypeptides, such as GPI-anchored PH20 polypeptides. The C-terminal GPI- anchor attachment signal sequence typically contains a predominantly hydrophobic region of 8- 20 amino acids, preceded by a hydrophilic spacer region of 8-12 amino acids, immediately downstream of the ω-site, or site of GPI-anchor attachment. GPI-anchor attachment signal sequences can be identified using methods well known in the art, such as but not limited to, in silico methods and algorithms (see, e.g. Udenfriend et al. (1995) Methods Enzymol.250:571- DB1 / 155561236.2 13 582, Eisenhaber et al., (1999) J. Biol. Chem.292: 741-758, Fankhauser et al., (2005) Bioinformatics 21:1846-1852, Omaetxebarria et al., (2007) Proteomics 7:1951-1960, Pierleoni et al., (2008) BMC Bioinformatics 9:392), including those that are readily available on bioinformatic websites, such as the ExPASy Proteomics tools site (e.g. the World Wide Web site expasy.ch / tools / ). As used herein, sequence identity refers to the relatedness between or among polypeptides among nucleic acid molecules. Sequence identity can be assessed by aligning two sequences and counting the number of differences between the aligned portion and the sequence to which it is compared. Whether any two molecules have nucleotide sequences or amino acid sequences that are at least 60%, 70%, 80%, 85%, 90%, 95%, 96%, 97%, 98% or 99% “identical” or “homologous” can be determined using known computer algorithms such as the “FASTA” program, using for example, the default parameters as in Pearson (1988) Proc. Natl. Acad. Sci. USA 85:2444 (other programs include the GCG program package (Devereux (1984) Nucleic Acids Research 12:387), BLASTP, BLASTN, FASTA (Altschul (1990) J. Mol. Biol.215:403); Guide to Huge Computers, Bishop, ed., Academic Press, 1994, and Carrillo (1988) SIAM J. Applied Math 48:1073). For example, the BLAST function of the National Center for Biotechnology Information database can be used to determine identity. Other commercially or publicly available programs include, DNAStar “MegAlign” program and the University of Wisconsin Genetics Computer Group (UWG) “Gap” program. Percent homology or identity of proteins and / or nucleic acid molecules can be determined, for example, by comparing sequence information using a GAP computer program (e.g. Needleman (1970) J. Mol. Biol.48:443, as revised by Smith and Waterman (1981) Adv. Appl. Math.2:482. Briefly, the GAP program defines similarity as the number of aligned symbols (i.e. nucleotides or amino acids), which are similar, divided by the total number of symbols in the shorter of the two sequences. Default parameters for the GAP program can include: (1) a unary comparison matrix (containing a value of 1 for identities and 0 for non-identities) and the weighted comparison matrix of Gribskov (1986) Nucl. Acids Res.14:6745, as described by Schwartz and Dayhoff, eds., Atlas of Protein Sequence and Structure, National Biomedical Research Foundation, pp.353-358 (1979); (2) a penalty of 3.0 for each gap and an additional 0.10 penalty for each symbol in each gap; and (3) no penalty for end gaps. Therefore, as used herein, the term “identity” or “homology” represents a comparison between a test and a reference polypeptide or polynucleotide. As used herein, the term at least “90% identical to” refers to percent identities from 90 to DB1 / 155561236.2 14 99.99 relative to the reference nucleic acid or amino acid sequence of the polypeptide. Identity at a level of 90% or more is indicative of the fact that, assuming for exemplification purposes a test and reference polypeptide length of 100 amino acids are compared. No more than 10% (i.e. 10 out of 100) of the amino acids in the test polypeptide differs from that of the reference polypeptide. Similar comparisons can be made between test and reference polynucleotides. Such differences can be represented as point mutations randomly distributed over the entire length of a polypeptide or they can be clustered in one or more locations of varying length up to the maximum allowable, e.g.10 / 100 amino acid difference (approximately 90% identity). Differences are defined as nucleic acid or amino acid substitutions, insertions or deletions. At the level of homologies or identities above about 85-90%, the result should be independent of the program and gap parameters set; such high levels of identity can be assessed readily, often by manual alignment without relying on software. As used herein, an aligned sequence refers to the use of homology (similarity and / or identity) to align corresponding positions in a sequence of nucleotides or amino acids. Typically, two or more sequences that are related by 50% or more identity are aligned. An aligned set of sequences refers to 2 or more sequences that are aligned at corresponding positions and can include aligning sequences derived from RNAs, such as ESTs and other cDNAs, aligned with genomic DNA sequence. As used herein, “denaturing condition” or “denaturation condition” refers to any condition or agent that, when exposed to a protein, affects or influences the degradation or denaturation of the protein, generally as a result of a loss or partial loss of the tertiary or secondary structure of the protein. Denaturing conditions can result in effects such as loss or reduction in activity, loss or reduction of solubility, aggregation and / or crystallization. As used herein, “resistance to a denaturation condition” refers to any amount of decreased reduction or elimination of a property or activity of the protein associated with or caused by denaturation. For example, denaturation is associated with or causes increased crystallization or aggregation, reduced solubility or decreased activity. Hence, resistance to denaturation means that the protein exhibits decreased aggregation or crystallization, increased solubility or increased or greater activity (e.g. hyaluronidase activity) when exposed to a denaturing condition compared to a reference protein (e.g. unmodified enzyme). As used herein, stability of a modified PH20 hyaluronidase means that it exhibits resistance to denaturation caused by a denaturation condition or denaturing agent. DB1 / 155561236.2 15 For clarity of disclosure, and not by way of limitation, the detailed description is divided into the subsections that follow. B. Soluble hyaluronidases Soluble hyaluronidases include any that, upon expression, are secreted from a cell and exist in soluble form. Such soluble hyaluronidases include, for example, but are not limited to, bacterial soluble hyaluronidases, non-human soluble hyaluronidases, such as bovine PH20 and ovine PH20, human soluble PH20, and variants thereof. Generally soluble forms of PH20 are produced using protein expression systems that facilitate correct N-glycosylation to ensure the polypeptide retains activity, since glycosylation is important for the catalytic activity and stability of hyaluronidases. Such cells include, for example Chinese Hamster Ovary (CHO) cells (e.g. DG44 CHO cells). Soluble PH20 hyaluronidase is available and sold, for example, under the trademark ENHANZE®. ENHANZE®technology provides to a drug delivery technology, employing the soluble hyaluronidases to facilitate the delivery of injected drugs and fluids. When co-formulated with other drugs or administered with other drugs, the ENHANZE®technology reduces treatment burden for patients. It can allow for large volume subcutaneous injection with increased dispersion and absorption of co-administered therapies. ENHANZE®technology has been marketed with biologics; it has not, prior to the instant description, been used for delivery of specific small molecules, nor for delivery of therapeutics for treatment and / or prevention of cancer. rHuPH20 refers to the composition produced upon expression in a cell, such as CHO cell, of nucleic acid encoding residues 36-482 of SEQ ID NO: 26, generally linked to the native or a heterologous signal sequence (residues 1-35 of SEQ ID NO: 26). rHuPH20 is produced by expression of a nucleic acid molecule, such as encoding amino acids 1-482 (set forth in SEQ ID NO: 26) in a mammalian cell. Translational processing removes the 35 amino acid signal sequence. As produced in the culture medium there is heterogeneity at the C-terminus such that the product, designated rHuPH20, includes a mixture of species that can include any one or more of the polypeptides 36-480, 36-481, and 36-482 of SEQ ID NO: 26, and some shorter polypeptides, in various abundance. rHuPH20 and forms of soluble hyaluronidase are produced in cells, such as CHO cells, for example DG44 CHO cells, that facilitate N-glycosylation. PH20 is a glycoprotein, and as known in the art, requires glycosylation retain activity. See, e.g. U.S. Patent Nos.8,927,249 and 9,284,543 (and PCT Publication No. WO 2010 / 077297), which DB1 / 155561236.2 16 describe the effects of glycosylation and partial glycosylation and elimination of glycosylation on the activity of soluble forms of PH20. These patents and publications also describe and exemplify I soluble C-terminally truncated forms of PH20. 1. Forms of Soluble Human PH20 Soluble hyaluronidases include bovine and ovine PH20, and recombinant and humanized forms thereof. Human PH20 in nature includes a GPI anchor and exists linked to sperm cells; it is not soluble. C-terminally-truncated forms thereof are soluble. Soluble forms of recombinant human PH20 have been produced and can be used in the compositions, combinations and methods described herein. Descriptions of and production of such soluble forms of PH20 are described, for example, in U.S. Patent Nos.7,767,429; 8,202,517; 8,431,380; 8,431,124; 8,450,470; 8,765,685; 8,772,246; 7,871,607; 7,846,431; 7,829,081; 8,105,586; 8,187,855; 8,257,699; 8,580,252; 9,677,061; and 9,677,062, each incorporated by reference herein. The soluble hyaluronidases, thus include forms of human PH20, which are neutral active hyaluronidases and which require glycosylation for activity. SEQ ID NO: 1 sets forth the sequence of the precursor polypeptides; the mature PH20 polypeptide (residues 36-509); soluble forms also include those with amino acid truncations at the N-terminal, such as deletions of the first one, two, three, or fours residues, such that the resulting polypeptides have an N-terminus, for example, at residue 36, 37, 38, 39, or 40, and a C- terminus at a residue from 465 to 500, and variants thereof, including, but not limited to, variants discussed below, variants known in the art, and allelic variants. Hyaluronidases for use in the compositions, combinations and methods herein are soluble neutral active hyaluronidases. Exemplary thereof are the soluble C-terminally truncated forms of mature human PH20. Soluble forms that have hyaluronidase activity, include but are not limited to, those that are truncated at residues from 465 to 500 of sequence ID No.1, and that are, upon expression, secreted. Exemplary thereof are polypeptides that have sequence 36-465, 36-466, 36- 467, 36-468, 36-469, 35-470, 36-471, 36-472, 36-474, 36-475, 36-476, 35-477, 36-478, 36-479, 36-480, 36-481, 36-482, 36-48335-484, 36-485, 36-486, 36-487, 36-488, 36-489, 36-490, 35- 491, 36-492, 36-493, 36-494, 36-495, 36-496, 36-497, 35-498, 36-499, and 36-500 of SEQ ID NO: 1, as well as N-terminally truncated forms of each of the preceding that lack two to five residues at the N-terminus, such as for example 37-368, 38-468, and any others that exhibit hyaluronidase activity at neutral pH, such as pH in the range of 7.0-7.4. Thus, such soluble forms include truncated forms of the mature form of human PH20 DB1 / 155561236.2 17 lacking all or a portion of the C-terminal GPI anchor, so long as the hyaluronidase is soluble and retains hyaluronidase activity. Soluble forms are secreted upon expression in mammalian cells, and are encoded with a signal sequence, such are residues 1-35 of SEQ ID NO.1 or a heterologous signal sequence that is cleaved by the cell to effect secretion. Soluble forms are forms that, when expressed in a cell, lack the signal peptide. Also included among soluble hyaluronidases are variants of the soluble PH20 polypeptides that exhibit hyaluronidase activity. Variants include polypeptides having at least 60%, 70%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or more sequence identity to any of the PH20 polypeptides 36-465, 36-466, 36-467, 36-468, 36-469, 35-470, 36-471, 36-472, 36-474, 36-475, 36-476, 35-477, 36- 478, 36-479, 36-480, 36-481, 36-482, 36-48335-484, 36-485, 36-486, 36-487, 36-488, 36-489, 36-490, 35-491, 36-492, 36-493, 36-494, 36-495, 36-496, 36-497, 35-498, 36-499, and 36-500 of SEQ ID NO: 1. Amino acid variants include conservative and non-conservative insertions, or deletions, or replacements, and include the modifications, singly or combinations of the modifications detailed, for example, in U.S. Patent No.11,041,149 and International PCT publication No. WO 2013 / 102144. U.S. Patent No.11,041,149 and International PCT publication No. WO 2013 / 102144 describe a systematic analysis and results identifying the effects of amino acid modifications at each residue in PH20 to thereby provide a structure / function map of PH20; a skilled person can identify replacement residues and consequent alterations in properties and activities, such as for effecting increases in enzymatic activity, stability in denaturing conditions, and also residues whose replacement or deletion decreases or eliminates enzymatic activity. It is understood that residues that are important or otherwise required for the activity of a hyaluronidase, such as any described above or known to those of skill in the art, are generally invariant and, except for possible conservative amino acid substitutions, cannot be changed. These include, for example, active site residues. For example, amino acid residues 111, 113 and 176 (corresponding to residues in the mature PH20 polypeptide) of a human PH20 polypeptide, or soluble form thereof, are generally invariant and are not altered. Other residues that confer glycosylation and formation of disulfide bonds required for proper folding also can be invariant. The soluble human PH20 hyaluronidase is GPI-anchored and is rendered soluble by truncation at the C-terminus by removal of all or a part of the GPI anchor. Such truncation can remove all of the GPI anchor attachment sequence or can remove only some of the GPI anchor attachment sequence. The resulting polypeptide, however, is soluble. In instances where the soluble hyaluronidase retains a portion of the GPI anchor attachment signal sequence, 1, 2, 3, 4, DB1 / 155561236.2 18 5, 6, 7 or more amino acid residues in the GPI anchor attachment signal sequence can be retained, provided the polypeptide is soluble. Polypeptides containing one or more amino acids of the GPI anchor are termed extended soluble hyaluronidases. One of skill in the art can determine whether a polypeptide is GPI-anchored using methods well known in the art. Such methods include, but are not limited to, using known algorithms to predict the presence and location of the GPI anchor attachment signal sequence and ω-site, and performing solubility analyses before and after digestion with phosphatidylinositol-specific phospholipase C (PI-PLC) or D (PI-PLD). Extended soluble hyaluronidases, which terminate for example, at residues 495, 496, 497, 498, 499, and 500, with reference to SEQ ID NO: 1, such as those set forth in SEQ ID NO: 52- 57, can be produced by making C-terminal truncations to any naturally GPI-anchored hyaluronidase such that the resulting polypeptide is soluble and contains one or more amino acid residues from the GPI anchor attachment signal sequence (see, e.g. U.S. Patent No.8,927,249). These include hyaluronidases that are neutral active, soluble, contain amino acid substitutions, and have at least 60%, 70%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95% or more sequence identity to any of SEQ ID NO: 52-57. Typically, for use in the compositions, combinations and methods herein, a soluble human hyaluronidase, such as a soluble human PH20, is used, such as a PH20 and variants having, for example, at least 91% or 95% or 98% sequence identity thereto, including those with 1 to 5 N-terminal residues deleted. Hyaluronidases used in the regimens, combinations, compositions, and methods herein can be recombinantly produced or can be purified or partially purified from natural sources, such as, for example, from testes extracts. Methods for production of recombinant proteins, including recombinant hyaluronidases, are well known in the art. Recombinant soluble forms of human PH20 have been generated and can be used in the compositions, combinations and methods provided herein. For example, with reference to SEQ ID NO: 1, which sets forth the sequence of full length precursor PH20, which includes a signal sequence (residues 1-35), soluble forms include, but are not limited to, C-terminal truncated polypeptides of human PH20 set forth in SEQ ID NO: 1 having a C-terminal amino acid residue 467, 468, 469, 470, 471, 472, 473, 474, 475, 476, 477, 478, 479, 480, 481, 482, 483, 484, 485, 486, 487, 488, 489, 490, 491, 492, 493, 494, 495, 496, 497, 498, 499 or 500 of the sequence of amino acids set forth in SEQ ID NO: 1, or polypeptides that exhibit at least 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or more sequence identity thereto, when aligned with the unmodified sequence of the soluble PH20, have activity at neutral pH, and are soluble DB1 / 155561236.2 19 (secreted into the medium when expressed in a mammalian cell). Soluble forms of human PH20 generally include those that contain amino acids 36-464 set forth in SEQ ID NO: 1 and terminate at any of residues, 465-500, and optionally include a 1-3 amino acid deletion at the N-terminus (i.e. lack residues 36, 36-37, or 36-38 of SEQ ID NO:1). For example, when expressed in mammalian cells, the 35 amino acid N-terminal signal sequence (residues 1-35 of SEQ ID NO:1) is cleaved during processing, and a soluble form of the protein is secreted. Thus, the mature soluble polypeptides include those that contain amino acids 36 to 467, 468, 469, 470, 471, 472, 473, 474, 475, 476, 477, 478, 479, 480, 481, 482, 483, and up to and including 500 of SEQ ID NO: 1. Exemplary of soluble hyaluronidases are soluble human PH20 polypeptides that are 442, 443, 444, 445, 446 or 447 amino acids in length, such as set forth those set forth above, and variants thereof that have, for example, at least 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% or 99% sequence identity thereto and retains hyaluronidase activity. The generation of such soluble forms of recombinant human PH20 are described, for example, in U.S. Patent No.7,767,429; 8,202,517; 8,431,380; 8,431,124; 8,450,470; 8,765,685; 8,772,246; 7,871,607; 7,846,431; 7,829,081; 8,105,586; 8,187,855; 8,257,699; 8,580,252; 9,677,061; and 9,677,062. Generally soluble forms of PH20 are produced using protein expression systems that facilitate correct N-glycosylation to ensure the polypeptide retains activity, since glycosylation is important for the catalytic activity and stability of hyaluronidases. Such cells include, for example Chinese Hamster Ovary (CHO) cells (e.g. DG44 CHO cells). The composition that recombinantly produced from mammalian cells, such as CHO cells, has been referred to rHuPH20. It refers to the composition produced upon expression in a cell, such as CHO cell, of nucleic acid encoding residues 36-482 of SEQ ID NO: 1, generally linked to the native (residues 1-35 of SEQ ID NO: 1) or a heterologous signal sequence. rHuPH20 is produced by expression of a nucleic acid molecule, such as encoding amino acids 1-482 (set forth in SEQ ID NO: 1) or 36 to 482 with a heterologous signal sequence. Post translational processing removes the 35 amino acid signal sequence, resulting in polypeptide or a mixture of polypeptides, including those set forth in SEQ ID NO: 3 and 44-49. As produced in the culture medium there is heterogeneity at the C-terminus such that the product, designated rHuPH20, includes a mixture of species that can include any one or more of SEQ ID NO: 3 and 44-49 in various abundance. Generally, the soluble hyaluronidases, rHuPH20 is produced in cells that facilitate correct N-glycosylation to retain activity, such as CHO cells (e.g. DG44 CHO cells). Human soluble PH20 hyaluronidase requires glycosylation for activity. When produced DB1 / 155561236.2 20 recombinantly from a vector encoding residues 36-582, the most abundant species is the 446 amino acid polypeptides corresponding to residues 36-481 of SEQ ID NO: 1. The particular distribution of resulting polypeptides can depend upon the particular method of production. An exemplary method for production of high levels of PH20 is detailed, for example in U.S. Patent Nos.8,187,855 and 8,343,487. 2. Glycosylation of hyaluronidases Glycosylation, including N- and O-linked glycosylation, of some hyaluronidases, including the soluble PH20 hyaluronidases, can be important for their catalytic activity and stability. For some hyaluronidases, removal of N-linked glycosylation can result in near complete inactivation of the hyaluronidase activity. For such hyaluronidases, the presence of N- linked glycans can be important for generating an active enzyme. N-linked oligosaccharides fall into several primary types (oligomannose, complex, hybrid, sulfated), all of which have (Man) 3-GlcNAc-GlcNAc- cores attached via the amide nitrogen of Asn residues that fall within -Asn-Xaa-Thr / Ser-sequences (where Xaa is not Pro). Glycosylation at an -Asn-Xaa-Cys-site has been reported for coagulation protein C. In some instances, a hyaluronidase, such as a PH20 hyaluronidase, can contain N-glycosidic and O- glycosidic linkages. For example, PH20 has O-linked oligosaccharides as well as N-linked oligosaccharides. There are six potential N-linked glycosylation sites at N82, N166, N235, N254, N368, N393 of human PH20 exemplified in SEQ ID NO: 1. 3. Variants As discussed above, variants of PH20 are known to those of skill in the art, or readily can be prepared in view of the skill and knowledge in the art. Variants include those with amino acid replacements, insertions, and deletions. Variants of the soluble PH20 polypeptides that have altered properties, such as increased stability and / or activity, have been produced. U.S. Patent No.9,447,401 and family members U.S. Patent Nos.10,865,400, 11,041,149 and 11,066,656 describe and provide a structure / function map of human PH20 detailing the effects of amino acid replacements at every residue in the catalytic domain of PH20. These patents provide about 7000 examples in which the effects of replacing each amino acid with 15 other amino acids on activity and stability were identified and described. By virtue of those patents, and earlier publications / patents, describing virtually all variants of soluble PH20 polypeptides are known in the art. A skilled person readily can prepare soluble hyaluronidases and variants thereof and know the properties of the resulting hyaluronidase. DB1 / 155561236.2 21 Other variants also are known to those of skill in the art, and can be used in the combinations, regimens, and methods described herein. For example, see, International PCT Publication No. WO2020 / 022791 and WO2020197230A which are incorporated by reference, and which describe modified PH20 polypeptides. These polypeptides, which include variants of the PH20 polypeptides that generally span residues 38-468, and include replacements, insertions, and deletions. The variants include for example one or more amino acid residues changes S343E, I344N, M345T, M348K, K349E, L353A, L354I, N356E, and I361T (with reference to SEQ ID NO:1), and others, including about 15 amino acid variations, and truncations at the N-terminus and C-terminus. Variants that contain such modifications and others are set forth in SEQ ID NO: 60-115 of International PCT publication No. WO2020 / 022791. Exemplary of these polypeptides is the polypeptide of SEQ ID NO:99, therein, and reproduced below as SEQ ID NO:2. International PCT Publication No. WO2021 / 150079 provides variant PH20 polypeptides described as having increased stability relative to unmodified PH20, such as those in rHuPH20. These variant polypeptides have been shown to have PH20 activity and are described as having use for subcutaneous co-administration with other agents. C. Methods of Administration and Regimens 1. Methods of Administration In an embodiment, each of the hyaluronidase and gamma globulin can be administered to a patient via injection. In an embodiment the hyaluronidase and gamma globulin is administered subcutaneously. For example, the hyaluronidase and gamma globulin can be administered to a patient subcutaneously in the abdominal tissue, leg or arm. The compositions for administration to a patient via an injection (e.g. subcutaneously) also may comprise suitable inert additives, stabilizers, carriers, or excipients. In an embodiment, the injectable composition comprises histidine. In an embodiment, the injectable composition comprises sodium chloride. In an embodiment, the injectable composition comprises polysorbate. In an embodiment, the polysorbate comprises polysorbate 80. In an embodiment, the injectable composition comprises an antioxidant. In an embodiment, the antioxidant comprises methionine. It is shown and described herein that when a gamma globulin is administered in combination with the hyaluronidase, dispersion of the co-injected gamma globulin is enhanced. By depolymerizing hyaluronan, hyaluronidase temporarily facilitates dispersion by reducing the viscosity of interstices. The permeability barrier in these tissues is restored to pre-injection levels DB1 / 155561236.2 22 within 24 to 48 hours after injection of hyaluronidase. This allows for higher volumes in a single injection of the gamma globulin to be administered to the patient. In an embodiment, the gamma globulin is administered at a concentration of about 10 mg / kg or about 50 mg / kg. In an embodiment, the gamma globulin is administered a concentration of about 100 mg / kg. 2. Regimens Provided are regimens for administration of an gamma globulin in combination with a soluble hyaluronidase. The gamma globulin generally is formulated as a solution for subcutaneous injection at effective concentrations, and the hyaluronidase is provided as a composition containing an effective concentration of soluble hyaluronidase for delivery of an effective amount of hyaluronidase in about 0.5 mL to 10 mL, such as 1 mL to 5 mL, or 1 mL to 3 mL. In accord with regimens and compositions provided herein, the hyaluronidase is administered in an amount suitable to allow a dose of from about 100 mg of the gamma globulin to be administered to the patient. Exemplary ranges include, but are not limited to, an amount suitable to allow a dose from 10 mg to 2000 mg be administered to the patient, or dose of at least 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 80 mg, 90 mg, 100 mg, 150 mg, 200 mg, 250 mg, 300 mg, 350 mg, 400 mg, 450 mg, 500 mg, 550 mg, 600 mg, 650 mg, 700 mg, 750 mg, 800 mg, 850 mg, 900 mg, 950 mg, 1000 mg, 1100 mg, 1200 mg, 1300 mg, 1400 mg, 1500 mg, 1600 mg, 1700 mg, 1800 mg, 1900 mg or 2000 mg or more to be administered to a patient. In other embodiments, the hyaluronidase is administered in an amount suitable to allow a dose of at least or at about an 100 mg to be administered. It is understood that a skilled practitioner can determine a particular dose, which can depend upon various parameters include the mass of the patient, the age of the patient, and other conditions of the patient. In an exemplary embodiment, an gamma globulin is administered at a dose of from 100 mg to 2000 mg, such as, but not limited to, a dose of from 900 mg to 2000 mg, such as for example, a dose of at least or at 10 mg to 1000 mg, such as for example, a dose of at least or at 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 80 mg, 90 mg, 100 mg, 150 mg, 200 mg, 250 mg, 300 mg, 350 mg, 400 mg, 450 mg, 500 mg, 550 mg, 600 mg, 650 mg, 700 mg, 750 mg, 800 mg, 850 mg, 900 mg, 950 mg, 1000 mg, 1100 mg, 1200 mg, 1300 mg, 1400 mg, 1500 mg, 1600 mg, 1700 mg, 1800 mg, 1900 mg or 2000 mg. Exemplary thereof the gamma globulin is administered at a dose of 1000 mg to 2000 mg or in amounts in between such doses. For DB1 / 155561236.2 23 example, the gamma globulin is administered at a dose of about 1500 mg, or at a dose of about 1750 mg, or at a dose of about 1900 mg, or at a dose of about 1950 mg. In an embodiment, the disclosed formulation is administered to the subject in multiple doses. Dosing may be about once, twice, three times, four times, five times, six times, or more than six times per day. Dosing may be about once a month, once every two weeks, once a week, or once every other day. In one embodiment, the disclosed formulation is administered about once per day to about 6 times per day. In one embodiment, the administration of the disclosed formulation continues for less than about 7 days. In yet another embodiment the administration continues for more than about 6, 10, 14, 28 days, two months, six months, or one year. In some cases, continuous dosing is achieved and maintained as long as necessary. Hyaluronidases have been used clinically since the 1950s. For example, rHuPH20, approved by the FDA in 2004, has been shown to be well tolerated in clinical evaluation of [subcutaneous] doses of up to 96,000 U, wherein U is USP units. For example, for purposes herein, hyaluronidase is administered at a dose of from 2000 to 15,000 U, such as, but not limited to from 5,000 to 15,000 U, such as 6,000 to 12,000 U, 8,000 to 12,000 U, such as at or about a dose of about 10,000 U, for example 10,000 U. The hyaluronidase is administered in volumes that range from at or about 0.5 mL to 10 mL, such as 1 mL to 5 mL, or at or about1 mL to 3 mL [injection], such as a 1 mL [injection]; the volume is a function of the specific activity of a particular formulation of the hyaluronidase. The particular amount depends upon parameters understood by those of skill in the art. In an embodiment, combination dosing regimen is provided that comprises administering hyaluronidase; and a gamma globulin, wherein hyaluronidase is administered at a dose of from 4000 to 15,000 U; and the gamma globulin is administered at a dose of from 10 to 100 mg / kg wherein the combination dosing regimen is administered once every 3 months to once every 6 months. 3. Methods of determining injection parameters In one aspect, the present disclosure provides a method of determining one or more parameters of an injection of a formulation in a human subject, the method comprising: administering to an animal subject via subcutaneous injection from a high volume autoinjector about 3 mL to about 50 mL of a formulation comprising a therapeutically effective amount of a hyaluronidase enzyme; DB1 / 155561236.2 24 measuring one or more parameters of the subcutaneous injection in the animal subject; and determining the same one or more parameters of the subcutaneous injection in the human subject from the one or more measured parameters from the animal subject; wherein the one or more parameters are selected from injection time, injection force, and injection site reaction data. In one embodiment, the hyaluronidase enzyme is a soluble hyaluronidase enzyme. In one embodiment, the hyaluronidase enzyme is a recombinant human hyaluronidase enzyme. In one embodiment, the hyaluronidase enzyme is a recombinant human hyaluronidase PH20 enzyme. In one embodiment, the soluble hyaluronidase enzyme comprises a sequence having at least 85%, at least 86%, at least 87%, at least 88%, at least 89%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% amino acid sequence identity to an amino acid sequence described elsewhere herein. In one embodiment, the soluble hyaluronidase enzyme comprises a sequence having at least 95% amino acid sequence identity to an amino acid sequence described elsewhere herein. In one embodiment, the recombinant human hyaluronidase PH20 enzyme comprises a sequence having at least 85%, at least 86%, at least 87%, at least 88%, at least 89%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% amino acid sequence identity to an amino acid sequence of SEQ ID NO: 1. In one embodiment, the recombinant human hyaluronidase PH20 enzyme comprises a sequence having at least 95% amino acid sequence identity to an amino acid sequence of SEQ ID NO: 1. In one embodiment, the hyaluronidase enzyme has an activity of between about 150 U / mL to about 1,000 kU / mL, about 150 U / mL to about 900 kU / mL, about 150 U / mL to about 800 kU / mL, about 150 U / mL to about 700 kU / mL, about 150 U / mL to about 600 kU / mL, about 150 U / mL to about 500 kU / mL, about 150 U / mL to about 400 kU / mL, about 150 U / mL to about 300 kU / mL, about 150 U / mL to about 200 kU / mL, about 500 U / mL to about 200 kU / mL, about 1 kU / mL to about 200 kU / mL, about 10 kU / mL to about 200 kU / mL, about 25 kU / mL to about 200 kU / mL, about 50 kU / mL to about 200 kU / mL, about 100 kU / mL to about 200 kU / mL, about 100 kU / mL to about 150 kU / mL, or about 120 kU / mL. In one embodiment, the hyaluronidase enzyme has an activity of about 10 kU / mL for a 5 mL formulation or about 5 kU / mL for a 10 mL formulation. In one embodiment, the hyaluronidase enzyme has a minimum activity of about 150 U / mL and a maximum activity of about 110,000 U / mL (110 kU / mL). In one embodiment, the hyaluronidase enzyme is recombinant human hyaluronidase PH20 enzyme with an activity of about 120 kU / mL. In another embodiment, the hyaluronidase enzyme is recombinant human DB1 / 155561236.2 25 hyaluronidase PH20 enzyme with a minimum activity of about 150 U / mL and a maximum activity of about 110,000 U / mL. In one embodiment, the concentration of hyaluronidase enzyme in the formulation is between about 10 U / mL to about 50,000 U / mL, about 10 U / mL to about 45,000 U / mL, about 10 U / mL to about 40,000 U / mL, about 10 U / mL to about 35,000 U / mL, about 10 U / mL to about 30,000 U / mL, about 10 U / mL to about 25,000 U / mL, about 10 U / mL to about 20,000 U / mL, about 10 U / mL to about 15,000 U / mL, about 10 U / mL to about 10,000 U / mL, about 100 U / mL to about 9,000 U / mL, about 100 U / mL to about 8,000 U / mL, about 100 U / mL to about 7,000 U / mL, about 100 U / mL to about 6,000 U / mL, about 100 U / mL to about 5,000 U / mL, about 500 U / mL to about 5,000 U / mL, about 500 U / mL to about 4,000 U / mL, about 500 U / mL to about 3,000 U / mL, about 1,000 U / mL to about 3,000 U / mL, about 1,500 U / mL to about 3,000 U / mL, about 1,500 U / mL to about 2,500 U / mL, or about 2,000 U / mL. In one embodiment, the formulation comprises about 1,500 U / mL to about 10,000 U / mL of hyaluronidase enzyme. In one embodiment, the formulation comprises about 1,500 U / mL to about 10,000 U / mL of recombinant human hyaluronidase PH20 enzyme. In one embodiment, the formulation comprises about 2,000 U / mL of recombinant human hyaluronidase PH20 enzyme. In one embodiment, the formulation comprises about 5,000 U / mL of recombinant human hyaluronidase PH20 enzyme. In another embodiment, the formulation comprises at least 4,000 U / mL of recombinant human hyaluronidase PH20 enzyme. In another embodiment, the formulation comprises at least 7,500 U / mL of recombinant human hyaluronidase PH20 enzyme. In another embodiment, the formulation comprises at least 10,000 U / mL of recombinant human hyaluronidase PH20 enzyme. In one embodiment, the formulation comprises about 4,000 U / mL of recombinant human hyaluronidase PH20 enzyme. In one embodiment, the formulation comprises a hyaluronidase enzyme that permits a high volume of the formulation to be injected into a subject in need thereof at a high flow rate. In one embodiment, the formulation comprises a hyaluronidase enzyme at a concentration and / or activity that permits a high volume of the formulation to be injected into a subject in need thereof at a high flow rate. In one embodiment, the formulation further comprises a therapeutically effective amount of an active ingredient selected from a small molecule, a protein, a peptide fragment, a biologic, a nanoparticle, an antibody, an antibody fragment, and a small molecule antiviral. In one embodiment, the formulation further comprises a monoclonal antibody. In one embodiment, the formulation further comprises a polyclonal antibody. The monoclonal or polyclonal antibody can be any monoclonal or polyclonal antibody that is suitable for high DB1 / 155561236.2 26 volume administration to a subject. In one embodiment, the monoclonal or polyclonal antibody can be any monoclonal or polyclonal antibody that is suitable for high volume administration to a subject using a high volume autoinjector. In one embodiment, a monoclonal or polyclonal antibody that is “suitable for high volume administration” refers to a monoclonal or polyclonal antibody wherein a therapeutically effective dose can be administered to a subject in a volume of greater than about 3 mL, greater than about 4 mL, greater than about 5 mL, greater than about 6 mL, greater than about 7 mL, greater than about 8 mL, greater than about 9 mL, greater than about 10 mL, greater than about 11 mL, greater than about 12 mL, greater than about 13 mL, greater than about 14 mL, greater than about 15 mL, greater than about 16 mL, greater than about 17 mL, greater than about 18 mL, greater than about 19 mL, or greater than about 20 mL. Exemplary monoclonal or polyclonal antibodies include, but are not limited to, trastuzumab, rituximab, pertuzumab, atezolizumab, immune globulin, daratumumab, efgartigimod alfa, nivolumab, and ocrelizumab. In one embodiment, the formulation comprises a combination of a recombinant human hyaluronidase PH20 enzyme and trastuzumab (e.g., Herceptin SC). In one embodiment, the formulation comprises a combination of a recombinant human hyaluronidase PH20 enzyme and rituximab (e.g., Mabthera SC). In one embodiment, the formulation comprises a combination of a recombinant human hyaluronidase PH20 enzyme, trastuzumab, and pertuzumab (e.g., Phesgo). In one embodiment, the formulation comprises a combination of a recombinant human hyaluronidase PH20 enzyme and atezolizumab (e.g., Tecentriq SC). In one embodiment, the formulation comprises a combination of a recombinant human hyaluronidase PH20 enzyme and immune globulin (e.g., HyQvia). In one embodiment, the formulation comprises a combination of a recombinant human hyaluronidase PH20 enzyme and daratumumab (e.g., Darzalex). In one embodiment, the formulation comprises a combination of a recombinant human hyaluronidase PH20 enzyme and efgartigimod alfa (e.g., Vyvgart). In one embodiment, the formulation comprises a combination of a recombinant human hyaluronidase PH20 enzyme and nivolumab (e.g., Opdivo Qvantig). In one embodiment, the formulation comprises a combination of a recombinant human hyaluronidase PH20 enzyme and ocrelizumab (e.g., Ocrevus SC). In one embodiment, the formulation further comprises gamma globulin. In one embodiment, the formulation comprises dose of gamma globulin described elsewhere herein. In one embodiment, the animal subject is a pig. In one embodiment, the animal subject is a miniature pig. In one embodiment, the animal subject is a Yucatan miniature pig. In one embodiment, the method comprises administering about 10 mL to about 20 mL of the formulation to the animal subject. In one embodiment, the method comprises administering DB1 / 155561236.2 27 about 10 mL to about 20 mL of the formulation to the human subject. In one embodiment, administering about 3 mL to about 15 mL of the formulation to the animal subject. In one embodiment, about 3 mL to about 15 mL of the formulation to the human subject. In one embodiment, the method comprises administering about 3 mL, about 3.1 mL, about 3.2 mL, about 3.4 mL, about 3.5 mL, about 3.6 mL, about 3.7 mL, about 3.8 mL, about 3.9 mL, about 4 mL, about 4.1 mL, about 4.2 mL, about 4.3 mL, about 4.4 mL, about 4.5 mL, about 5 mL, about 5.1 mL, about 5.2 mL, about 5.3 mL, about 5.4 mL, about 5.5 mL, about 5.6 mL, about 5.7 mL, about 5.8 mL, about 5.9 mL, about 6 mL, about 6.1 mL, about 6.2 mL, about 6.3 mL, about 6.4 mL, about 6.5 mL, about 6.6 mL, about 6.7 mL, about 6.8 mL, about 6.9 mL, about 7 mL, about 7.1 mL, about 7.2 mL, about 7.3 mL about 7.4 mL, about 7.5 mL, about 7.6 mL, about 7.7 mL, about 7.8 mL, about 7.9 mL, about 8 mL, about 8.1 mL, about 8.2 mL, about 8.3 mL, about 8.4 mL, about 8.5 mL, about 8.6 mL, about 8.7 mL, about 8.8 mL, about 8.9 mL, about 9 mL, about 9.1 mL, about 9.2 mL, about 9.3 mL, about 9.4 mL, about 9.5 mL, about 9.6 mL, about 9.7 mL, about 9.8 mL, about 9.9 mL, about 10 mL, about 10.1 mL, about 10.2 mL, about 10.3 mL, about 10.4 mL, about 10.5 mL, about 10.6 mL, about 10.7 mL, about 10.8 mL, about 10.9 mL, about 11 mL, about 11.1 mL, about 11.2 mL, about 11.3 mL, about 11.4 mL, about 11.5 mL, about 11.6 mL, about 11.7 mL, about 11.8 mL, about 11.9 mL, about 12 mL, about 12.1 mL, about 12.2 mL, about 12.3 mL, about 12.4 mL, about 12.5 mL, about 12.6 mL, about 12.7 mL, about 12.8 mL, about 12.9 mL, about 13 mL, about 13.1 mL, about 13.2 mL, about 13.3 mL, about 13.4 mL, about 13.5 mL, about 13.6 mL, about 13.7 mL, about 13.8 mL, about 13.9 mL, about 14 mL, about 14.1 mL, about 14.2 mL, about 14.3 mL, about 14.4 mL, about 14.5 mL, about 14.6 mL, about 14.7 mL, about 14.8 mL, about 14.9 mL, about 15 mL, about 15.1 mL, about 15.2 mL, about 15.3 mL, about 15.4 mL, about 15.5 mL, about 15.6 mL, about 15.7 mL, about 15.8 mL, about 15.9 mL, about 16 mL, about 16.1 mL, about 16.2 mL, about 16.3 mL, about 16.4 mL, about 16.5 mL, about 16.6 mL, about 16.7 mL, about 16.8 mL, about 16.9 mL about 17 mL, about 17.1 mL, about 17.2 mL, about 17.3 mL, about 17.4 mL, about 17.5 mL, about 17.6 mL, about 17.7 mL, about 17.8 mL, about 17.9 mL, about 18 mL, about 18.1 mL, about 18.2 mL, about 18.3 mL, about 18.4 mL, about 18.5 mL, about 18.6 mL, about 18.7 mL, about 18.8 mL, about 18.9 mL, about 19 mL, about 19.1 mL, about 19.2 mL, about 19.3 mL, about 19.4 mL, about 19.5 mL, about 19.6 mL, about 19.7 mL, about 19.8 mL, about 19.9 mL, about 20 mL, about 20.1 mL, about 20.2 mL, about 20.3 mL, about 20.4 mL, about 20.5 mL, about 20.6 mL, about 20.7 mL, about 20.8 mL, about 20.9 mL, about 21 mL, about 21.1 mL, about 21.2 mL, about 21.3 mL, about 21.4 mL, about 21.5 mL, about 21.6 mL, about 21.7 mL, about 21.8 mL, about 21.9 mL, about 22 mL, about 22.1 mL, about 22.2 mL, about 22.3 mL, about 22.4 DB1 / 155561236.2 28 mL, about 22.5 mL, about 22.6 mL, about 22.7 mL, about 22.8 mL, about 22.9 mL, about 23 mL, about 23.1 mL, about 23.2 mL, about 23.3 mL, about 23.4 mL, about 23.5 mL, about 23.6 mL, about 23.7 mL, about 23.8 mL, about 23.9 mL, about 24 mL, about 24.1 mL, about 24.2 mL, about 24.3 mL, about 24.4 mL, about 24.5 mL, about 24.6 mL, about 24.7 mL, about 24.8 mL, about 24.9 mL, or about 25 mL to the animal subject. In one embodiment, the method comprises administering about 3 mL, about 3.1 mL, about 3.2 mL, about 3.4 mL, about 3.5 mL, about 3.6 mL, about 3.7 mL, about 3.8 mL, about 3.9 mL, about 4 mL, about 4.1 mL, about 4.2 mL, about 4.3 mL, about 4.4 mL, about 4.5 mL, about 5 mL, about 5.1 mL, about 5.2 mL, about 5.3 mL, about 5.4 mL, about 5.5 mL, about 5.6 mL, about 5.7 mL, about 5.8 mL, about 5.9 mL, about 6 mL, about 6.1 mL, about 6.2 mL, about 6.3 mL, about 6.4 mL, about 6.5 mL, about 6.6 mL, about 6.7 mL, about 6.8 mL, about 6.9 mL, about 7 mL, about 7.1 mL, about 7.2 mL, about 7.3 mL about 7.4 mL, about 7.5 mL, about 7.6 mL, about 7.7 mL, about 7.8 mL, about 7.9 mL, about 8 mL, about 8.1 mL, about 8.2 mL, about 8.3 mL, about 8.4 mL, about 8.5 mL, about 8.6 mL, about 8.7 mL, about 8.8 mL, about 8.9 mL, about 9 mL, about 9.1 mL, about 9.2 mL, about 9.3 mL, about 9.4 mL, about 9.5 mL, about 9.6 mL, about 9.7 mL, about 9.8 mL, about 9.9 mL, about 10 mL, about 10.1 mL, about 10.2 mL, about 10.3 mL, about 10.4 mL, about 10.5 mL, about 10.6 mL, about 10.7 mL, about 10.8 mL, about 10.9 mL, about 11 mL, about 11.1 mL, about 11.2 mL, about 11.3 mL, about 11.4 mL, about 11.5 mL, about 11.6 mL, about 11.7 mL, about 11.8 mL, about 11.9 mL, about 12 mL, about 12.1 mL, about 12.2 mL, about 12.3 mL, about 12.4 mL, about 12.5 mL, about 12.6 mL, about 12.7 mL, about 12.8 mL, about 12.9 mL, about 13 mL, about 13.1 mL, about 13.2 mL, about 13.3 mL, about 13.4 mL, about 13.5 mL, about 13.6 mL, about 13.7 mL, about 13.8 mL, about 13.9 mL, about 14 mL, about 14.1 mL, about 14.2 mL, about 14.3 mL, about 14.4 mL, about 14.5 mL, about 14.6 mL, about 14.7 mL, about 14.8 mL, about 14.9 mL, about 15 mL, about 15.1 mL, about 15.2 mL, about 15.3 mL, about 15.4 mL, about 15.5 mL, about 15.6 mL, about 15.7 mL, about 15.8 mL, about 15.9 mL, about 16 mL, about 16.1 mL, about 16.2 mL, about 16.3 mL, about 16.4 mL, about 16.5 mL, about 16.6 mL, about 16.7 mL, about 16.8 mL, about 16.9 mL about 17 mL, about 17.1 mL, about 17.2 mL, about 17.3 mL, about 17.4 mL, about 17.5 mL, about 17.6 mL, about 17.7 mL, about 17.8 mL, about 17.9 mL, about 18 mL, about 18.1 mL, about 18.2 mL, about 18.3 mL, about 18.4 mL, about 18.5 mL, about 18.6 mL, about 18.7 mL, about 18.8 mL, about 18.9 mL, about 19 mL, about 19.1 mL, about 19.2 mL, about 19.3 mL, about 19.4 mL, about 19.5 mL, about 19.6 mL, about 19.7 mL, about 19.8 mL, about 19.9 mL, about 20 mL, about 20.1 mL, about 20.2 mL, about 20.3 mL, about 20.4 mL, about 20.5 mL, about 20.6 mL, about 20.7 mL, about 20.8 mL, about 20.9 mL, about 21 mL, about 21.1 mL, about 21.2 mL, about 21.3 mL, DB1 / 155561236.2 29 about 21.4 mL, about 21.5 mL, about 21.6 mL, about 21.7 mL, about 21.8 mL, about 21.9 mL, about 22 mL, about 22.1 mL, about 22.2 mL, about 22.3 mL, about 22.4 mL, about 22.5 mL, about 22.6 mL, about 22.7 mL, about 22.8 mL, about 22.9 mL, about 23 mL, about 23.1 mL, about 23.2 mL, about 23.3 mL, about 23.4 mL, about 23.5 mL, about 23.6 mL, about 23.7 mL, about 23.8 mL, about 23.9 mL, about 24 mL, about 24.1 mL, about 24.2 mL, about 24.3 mL, about 24.4 mL, about 24.5 mL, about 24.6 mL, about 24.7 mL, about 24.8 mL, about 24.9 mL, or about 25 mL to the human subject. In one embodiment, the method comprises administering the same amount of the formulation to both the animal subject and the human subject. In one embodiment, the method comprises administering about 10 mL of the formulation to both the animal subject and the human subject. In one embodiment, the formulation is in a prefilled syringe. In one embodiment, the prefilled syringe contains about 3 mL, about 3.1 mL, about 3.2 mL, about 3.4 mL, about 3.5 mL, about 3.6 mL, about 3.7 mL, about 3.8 mL, about 3.9 mL, about 4 mL, about 4.1 mL, about 4.2 mL, about 4.3 mL, about 4.4 mL, about 4.5 mL, about 5 mL, about 5.1 mL, about 5.2 mL, about 5.3 mL, about 5.4 mL, about 5.5 mL, about 5.6 mL, about 5.7 mL, about 5.8 mL, about 5.9 mL, about 6 mL, about 6.1 mL, about 6.2 mL, about 6.3 mL, about 6.4 mL, about 6.5 mL, about 6.6 mL, about 6.7 mL, about 6.8 mL, about 6.9 mL, about 7 mL, about 7.1 mL, about 7.2 mL, about 7.3 mL about 7.4 mL, about 7.5 mL, about 7.6 mL, about 7.7 mL, about 7.8 mL, about 7.9 mL, about 8 mL, about 8.1 mL, about 8.2 mL, about 8.3 mL, about 8.4 mL, about 8.5 mL, about 8.6 mL, about 8.7 mL, about 8.8 mL, about 8.9 mL, about 9 mL, about 9.1 mL, about 9.2 mL, about 9.3 mL, about 9.4 mL, about 9.5 mL, about 9.6 mL, about 9.7 mL, about 9.8 mL, about 9.9 mL, about 10 mL, about 10.1 mL, about 10.2 mL, about 10.3 mL, about 10.4 mL, about 10.5 mL, about 10.6 mL, about 10.7 mL, about 10.8 mL, about 10.9 mL, about 11 mL, about 11.1 mL, about 11.2 mL, about 11.3 mL, about 11.4 mL, about 11.5 mL, about 11.6 mL, about 11.7 mL, about 11.8 mL, about 11.9 mL, about 12 mL, about 12.1 mL, about 12.2 mL, about 12.3 mL, about 12.4 mL, about 12.5 mL, about 12.6 mL, about 12.7 mL, about 12.8 mL, about 12.9 mL, about 13 mL, about 13.1 mL, about 13.2 mL, about 13.3 mL, about 13.4 mL, about 13.5 mL, about 13.6 mL, about 13.7 mL, about 13.8 mL, about 13.9 mL, about 14 mL, about 14.1 mL, about 14.2 mL, about 14.3 mL, about 14.4 mL, about 14.5 mL, about 14.6 mL, about 14.7 mL, about 14.8 mL, about 14.9 mL, about 15 mL, about 15.1 mL, about 15.2 mL, about 15.3 mL, about 15.4 mL, about 15.5 mL, about 15.6 mL, about 15.7 mL, about 15.8 mL, about 15.9 mL, about 16 mL, about 16.1 mL, about 16.2 mL, about 16.3 mL, about 16.4 mL, about 16.5 mL, about 16.6 mL, about 16.7 mL, about 16.8 mL, about 16.9 mL about 17 mL, about 17.1 mL, about 17.2 mL, about 17.3 mL, about 17.4 mL, about 17.5 mL, about 17.6 mL, about 17.7 mL, DB1 / 155561236.2 30 about 17.8 mL, about 17.9 mL, about 18 mL, about 18.1 mL, about 18.2 mL, about 18.3 mL, about 18.4 mL, about 18.5 mL, about 18.6 mL, about 18.7 mL, about 18.8 mL, about 18.9 mL, about 19 mL, about 19.1 mL, about 19.2 mL, about 19.3 mL, about 19.4 mL, about 19.5 mL, about 19.6 mL, about 19.7 mL, about 19.8 mL, about 19.9 mL, about 20 mL, about 20.1 mL, about 20.2 mL, about 20.3 mL, about 20.4 mL, about 20.5 mL, about 20.6 mL, about 20.7 mL, about 20.8 mL, about 20.9 mL, about 21 mL, about 21.1 mL, about 21.2 mL, about 21.3 mL, about 21.4 mL, about 21.5 mL, about 21.6 mL, about 21.7 mL, about 21.8 mL, about 21.9 mL, about 22 mL, about 22.1 mL, about 22.2 mL, about 22.3 mL, about 22.4 mL, about 22.5 mL, about 22.6 mL, about 22.7 mL, about 22.8 mL, about 22.9 mL, about 23 mL, about 23.1 mL, about 23.2 mL, about 23.3 mL, about 23.4 mL, about 23.5 mL, about 23.6 mL, about 23.7 mL, about 23.8 mL, about 23.9 mL, about 24 mL, about 24.1 mL, about 24.2 mL, about 24.3 mL, about 24.4 mL, about 24.5 mL, about 24.6 mL, about 24.7 mL, about 24.8 mL, about 24.9 mL, or about 25 mL of the formulation. In one embodiment, the prefilled syringe comprises a needle having a gauge of about 20 to about 33. In one embodiment, the prefilled syringe comprises a BDL needle having a gauge of about 20 to about 33. In one embodiment, the prefilled syringe comprises a needle having a gauge of about 20 to about 33. In one embodiment, the prefilled syringe comprises a 20 gauge needle, a 21 gauge needle, a 22 gauge needle, a 23 gauge needle, a 24 gauge needle, a 25 gauge needle, a 26 gauge needle, a 27 gauge needle, a 28 gauge needle, a 29 gauge needle, a 30 gauge needle, a 31 gauge needle, a 32 gauge needle, or a 33 gauge needle. In one embodiment, the prefilled syringe comprises a 20 gauge needle, a 21 gauge needle, a 22 gauge needle, a 23 gauge needle, a 24 gauge needle, a 25 gauge needle, a 26 gauge needle, a 27 gauge needle, a 28 gauge needle, a 29 gauge needle, a 30 gauge needle, a 31 gauge needle, a 32 gauge needle, or a 33 gauge needle. In one embodiment, the prefilled syringe comprises a 25 gauge Terumo needle. In one embodiment, the prefilled syringe comprises a 25 gauge BDL needle. In one embodiment, the method comprises administering the formulation to the animal subject at a rate of about 0.08 mL / sec to about 1.00 mL / sec. In one embodiment, the method comprises administering the formulation to the human subject at a rate of about 0.08 mL / sec to about 1.00 mL / sec. In one embodiment, the method comprises administering the formulation to the animal subject at a rate of at least about 0.08 mL / sec to about 1.0 mL / sec. In one embodiment, the method comprises administering the formulation to the human subject at a rate of at least about 0.08 mL / sec to about 1.0 mL / sec. In one embodiment, the method comprises administering the formulation to the animal subject at a rate of at least or faster than about 0.08 mL / sec to about 1.00 mL / sec. In one embodiment, the method comprises administering the DB1 / 155561236.2 31 formulation to the human subject at a rate of at least or faster than about 0.08 mL / sec to about 1.00 mL / sec. In one embodiment, the method comprises administering the formulation to the animal subject and the human subject at the same rate or about the same rate. In one embodiment, administering the formulation to the animal subject takes about 10 seconds to about 40 seconds. In one embodiment, administering the formulation to the human subject takes about 10 seconds to about 40 seconds. In one embodiment, administering the formulation to the animal subject takes at least about 10 seconds to about 40 seconds. In one embodiment, administering the formulation to the human subject takes at least about 10 seconds to about 40 seconds. In one embodiment, administering the formulation to the animal subject takes at least or less than about 10 seconds to about 40 seconds. In one embodiment, administering the formulation to the human subject takes at least or less than about 10 seconds to about 40 seconds. In one embodiment, administering the formulation to the animal subject takes about 15 seconds to about 30 seconds. In one embodiment, administering the formulation to the human subject takes about 15 seconds to about 30 seconds. In one embodiment, administering the formulation to the animal subject takes at least about 15 seconds to about 30 seconds. In one embodiment, administering the formulation to the human subject takes at least about 15 seconds to about 30 seconds. In one embodiment, administering the formulation to the animal subject takes at least or less than about 15 seconds to about 30 seconds. In one embodiment, administering the formulation to the human subject takes at least or less than about 15 seconds to about 30 seconds. In one embodiment, the method comprises administering about 10 mL of the formulation to the animal subject at a rate of about 0.32 mL / sec to about 0.42 mL / sec. In one embodiment, the method comprises administering about 10 mL of the formulation to the human subject at a rate of about 0.32 mL / sec to about 0.42 mL / sec. In one embodiment, the method comprises administering about 10 mL of the formulation to the animal subject and the human subject at a rate of about 0.32 mL / sec to about 0.42 mL / sec. Injection force In one embodiment, the one or more parameters is injection force. In one embodiment, the animal subject used for injection force measurements is a pig. In one embodiment, the animal subject used for injection force measurements is a miniature pig. In one embodiment, the animal subject used for injection force measurements is a Yucatan miniature pig. In one embodiment, the formulation used for injection force measurements further comprises gamma globulin. In one embodiment, the formulation comprises a dose of gamma globulin described elsewhere herein. DB1 / 155561236.2 32 In one embodiment, the subcutaneous administration to the animal subject of the formulation used for injection force measurements occurs via a high volume autoinjector fitted with a 25 gauge needle. In one embodiment, the subcutaneous administration to the animal subject of the formulation used for injection force measurements occurs via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. In one embodiment, the high volume autoinjector is fitted with a 25 gauge Terumo needle. In one embodiment, the high volume autoinjector is fitted with a 25 gauge BDL needle. In one embodiment, the prefilled syringe is fitted with a 25 gauge Terumo needle. In one embodiment, the prefilled syringe is fitted with a 25 gauge BDL needle. In one embodiment, the subcutaneous administration to the human subject occurs via a high volume autoinjector fitted with a 25 gauge needle. In one embodiment, the subcutaneous administration to the human subject occurs via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. In one embodiment, the high volume autoinjector is fitted with a 25 gauge Terumo needle. In one embodiment, the high volume autoinjector is fitted with a 25 gauge BDL needle. In one embodiment, the prefilled syringe is fitted with a 25 gauge Terumo needle. In one embodiment, the prefilled syringe is fitted with a 25 gauge BDL needle. In one embodiment, the subcutaneous administration to the human subject occurs via a high volume autoinjector that is the same or substantially the same as the one used for administration of the formulation to the animal subject. In one embodiment, the method further comprises determining the injection force of the subcutaneous injection in the human subject by multiplying the measured injection force of the animal subject by a scaling factor. In one embodiment, the scaling factor is about 0.80 to about 0.99. In one embodiment, the scaling factor is about 0.85 to about 0.95. In one embodiment, the scaling factor is about 0.88 to about 0.92. In one embodiment, the injection force is measured in Newtons (N). In one embodiment, the method comprises: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.42 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the injection force of the subcutaneous injection in the miniature pig to be about 25 N to about 50 N; and determining the injection force of an identical subcutaneous injection in the human subject by multiplying the miniature pig injection force by a scaling factor of about 0.85 to about 0.95, obtaining an estimated injection force of about 21 N to about 48 N. DB1 / 155561236.2 33 In one embodiment, the method comprises: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.36 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the injection force of the subcutaneous injection in the miniature pig to be about 40 N to about 46 N; and determining the injection force of an identical subcutaneous injection in the human subject by multiplying the miniature pig injection force by a scaling factor of about 0.88 to about 0.92, obtaining an estimated injection force of about 35 N to about 42 N. In one embodiment, the subcutaneous administration to the animal subject comprises a single injection. In one embodiment, the subcutaneous administration to the human subject comprises a single injection. In one embodiment, the subcutaneous administration to the animal subject and the human subject comprises a single injection. In one embodiment, the subcutaneous administration to the animal subject comprises two or more injections. In one embodiment, the subcutaneous administration to the human subject comprises two or more injections. In one embodiment, the subcutaneous administration to the animal subject and the human subject comprises two or more injections. Injection time In one embodiment, the one or more measured parameters is injection time. In one embodiment, the animal subject used for injection time measurements is a pig. In one embodiment, the animal subject used for injection time measurements is a miniature pig. In one embodiment, the animal subject used for injection time measurements is a Yucatan miniature pig. In one embodiment, the formulation used for injection time measurements further comprises gamma globulin. In one embodiment, the formulation comprises a dose of gamma globulin described elsewhere herein. In one embodiment, the subcutaneous administration to the animal subject of the formulation used for injection time measurements occurs via a high volume autoinjector fitted with a 25 gauge needle. In one embodiment, the subcutaneous administration to the animal subject of the formulation used for injection time measurements occurs via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. In one embodiment, the high volume autoinjector is fitted with a 25 gauge Terumo needle. In one embodiment, the high volume autoinjector is fitted with a 25 gauge BDL needle. In one DB1 / 155561236.2 34 embodiment, the prefilled syringe is fitted with a 25 gauge Terumo needle. In one embodiment, the prefilled syringe is fitted with a 25 gauge BDL needle. In one embodiment, the subcutaneous administration to the human subject occurs via a high volume autoinjector fitted with a 25 gauge needle. In one embodiment, the subcutaneous administration to the human subject occurs via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. In one embodiment, the high volume autoinjector is fitted with a 25 gauge Terumo needle. In one embodiment, the high volume autoinjector is fitted with a 25 gauge BDL needle. In one embodiment, the prefilled syringe is fitted with a 25 gauge Terumo needle. In one embodiment, the prefilled syringe is fitted with a 25 gauge BDL needle. In one embodiment, the subcutaneous administration to the human subject occurs via a high volume autoinjector that is the same or substantially the same as the one used for administration of the formulation to the animal subject. In one embodiment, the method comprises determining the injection time of the subcutaneous injection in the human subject by multiplying the measured injection time of the animal subject by a scaling factor. In one embodiment, the scaling factor is about 0.80 to about 0.99. In one embodiment, the scaling factor is about 0.85 to about 0.95. In one embodiment, the scaling factor is about 0.88 to about 0.92. In one embodiment, the injection time is measured in seconds. In one embodiment, the method comprises: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.36 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the injection time of the subcutaneous injection in the miniature pig to be about 15 seconds to about 35 seconds; and determining the injection time of an identical subcutaneous injection in the human subject by multiplying the miniature pig injection time by a scaling factor of about 0.85 to about 0.95, obtaining an estimated injection time of about 13 seconds to about 33 seconds. In one embodiment, the method comprises: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.36 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the injection time of the subcutaneous injection in the miniature pig to be about 18 seconds to about 30 seconds; and DB1 / 155561236.2 35 determining the injection time of an identical subcutaneous injection in the human subject by multiplying the miniature pig injection time by a scaling factor of about 0.88 to about 0.92, obtaining an estimated injection time of about 16 seconds to about 28 seconds. In one embodiment, the subcutaneous administration to the animal subject comprises a single injection. In one embodiment, the subcutaneous administration to the human subject comprises a single injection. In one embodiment, the subcutaneous administration to the animal subject and the human subject comprises a single injection. In one embodiment, the subcutaneous administration to the animal subject comprises two or more injections. In one embodiment, the subcutaneous administration to the human subject comprises two or more injections. In one embodiment, the subcutaneous administration to the animal subject and the human subject comprises two or more injections. Injection site reaction data In one embodiment, the one or more measured parameters is injection site reaction data. In one embodiment, the injection site reaction data comprises one or more of back leakage at the injection site, swelling volume at the injection site, swelling height at the injection site, bleb swelling size at the injection site, bleb induration at the injection site, and bleb resolution at the injection site. In one embodiment, the animal subject used for injection site reaction data measurements is a pig. In one embodiment, the animal subject used for injection site reaction data measurements is a miniature pig. In one embodiment, the animal subject used for injection site reaction data measurements is a Yucatan miniature pig. In one embodiment, the formulation used for injection site reaction data measurements further comprises gamma globulin. In one embodiment, the formulation comprises a dose of gamma globulin described elsewhere herein. In one embodiment, the subcutaneous administration to the animal subject of the formulation used for injection site reaction data measurements occurs via a high volume autoinjector fitted with a 25 gauge needle. In one embodiment, the subcutaneous administration to the animal subject of the formulation used for injection site reaction data measurements occurs via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. In one embodiment, the high volume autoinjector is fitted with a 25 gauge Terumo needle. In one embodiment, the high volume autoinjector is fitted with a 25 gauge BDL needle. In one embodiment, the prefilled syringe is fitted with a 25 gauge Terumo needle. In one embodiment, the prefilled syringe is fitted with a 25 gauge BDL needle. DB1 / 155561236.2 36 In one embodiment, the subcutaneous administration to the human subject occurs via a high volume autoinjector fitted with a 25 gauge needle. In one embodiment, the subcutaneous administration to the human subject occurs via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. In one embodiment, the high volume autoinjector is fitted with a 25 gauge Terumo needle. In one embodiment, the high volume autoinjector is fitted with a 25 gauge BDL needle. In one embodiment, the prefilled syringe is fitted with a 25 gauge Terumo needle. In one embodiment, the prefilled syringe is fitted with a 25 gauge BDL needle. In one embodiment, the subcutaneous administration to the human subject occurs via a high volume autoinjector that is the same or substantially the same as the one used for administration of the formulation to the animal subject. In one embodiment, the method comprises: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.42 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the one or more injection site reactions of the subcutaneous injection in the miniature pig and assigning a score from 0, 1, 2, 3, or 4; and determining that the one or more injection site reactions of an identical subcutaneous injection in the human subject will have the same score. In one embodiment, the method comprises: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.36 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the one or more injection site reactions of the subcutaneous injection in the miniature pig and assigning a score from 0, 1, 2, 3, or 4; and determining that the one or more injection site reactions of an identical subcutaneous injection in the human subject will have the same score. In one embodiment, the subcutaneous administration to the animal subject comprises a single injection. In one embodiment, the subcutaneous administration to the human subject comprises a single injection. In one embodiment, the subcutaneous administration to the animal subject and the human subject comprises a single injection. In one embodiment, the subcutaneous administration to the animal subject comprises two or more injections. In one embodiment, the subcutaneous administration to the human subject comprises two or more injections. In one embodiment, the subcutaneous administration to the animal subject and the human subject comprises two or more injections. DB1 / 155561236.2 37 Clauses of the Disclosure Clause 1. A method of determining one or more parameters of an injection of a formulation in a human subject, the method comprising: administering to an animal subject via subcutaneous injection from a high volume autoinjector about 3 mL to about 50 mL of a formulation comprising a therapeutically effective amount of a hyaluronidase enzyme; measuring one or more parameters of the subcutaneous injection in the animal subject; and determining the same one or more parameters of the subcutaneous injection in the human subject from the one or more measured parameters from the animal subject; wherein the one or more parameters are selected from injection time, injection force, and injection site reaction data. Clause 2. The method of clause 1, the hyaluronidase enzyme is a soluble hyaluronidase enzyme. Clause 3. The method of clause 1 or 2, wherein the hyaluronidase enzyme is a recombinant human hyaluronidase enzyme. Clause 4. The method of any one of clauses 1-3, wherein the hyaluronidase enzyme is a recombinant human hyaluronidase PH20 enzyme. Clause 5. The method of clause 4, wherein the recombinant human hyaluronidase PH20 enzyme comprises a sequence having at least 95% amino acid sequence identity to an amino acid sequence of SEQ ID NO: 1. Clause 6. The method of any one of clauses 1-5, wherein the formulation further comprises a therapeutically effective amount of an active ingredient selected from a small molecule, a protein, a peptide fragment, a biologic, a nanoparticle, an antibody, an antibody fragment, and a small molecule antiviral. Clause 7. The method of clause 6, wherein the antibody comprises a monoclonal antibody or a polyclonal antibody. Clause 8. The method of clause 7, wherein the monoclonal antibody or the polyclonal antibody comprises trastuzumab, rituximab, pertuzumab, atezolizumab, immune globulin, daratumumab, efgartigimod alfa, nivolumab, or ocrelizumab. Clause 9. The method of clause 6, wherein the protein comprises gamma globulin. Clause 10. The method of any one of clauses 1-9, wherein the animal subject is a miniature pig. Clause 11. The method of any one of clauses 1-10, wherein the animal subject is a Yucatan miniature pig. Clause 12. The method of any one of clauses 1-11, comprising administering about 10 mL to about 20 mL of the formulation to the animal subject. DB1 / 155561236.2 38 Clause 13. The method of any one of clauses 1-9, comprising administering about 10 mL to about 20 mL of the formulation to the human subject. Clause 14. The method of any one of clauses 1-12, comprising administering about 3 mL to about 15 mL of the formulation to the animal subject. Clause 15. The method of any one of clauses 1-9 or 13, comprising administering about 3 mL to about 15 mL of the formulation to the human subject. Clause 16. The method of any one of clauses 1-12 or 14, comprising administering about 3 mL, about 3.1 mL, about 3.2 mL, about 3.4 mL, about 3.5 mL, about 3.6 mL, about 3.7 mL, about 3.8 mL, about 3.9 mL, about 4 mL, about 4.1 mL, about 4.2 mL, about 4.3 mL, about 4.4 mL, about 4.5 mL, about 5 mL, about 5.1 mL, about 5.2 mL, about 5.3 mL, about 5.4 mL, about 5.5 mL, about 5.6 mL, about 5.7 mL, about 5.8 mL, about 5.9 mL, about 6 mL, about 6.1 mL, about 6.2 mL, about 6.3 mL, about 6.4 mL, about 6.5 mL, about 6.6 mL, about 6.7 mL, about 6.8 mL, about 6.9 mL, about 7 mL, about 7.1 mL, about 7.2 mL, about 7.3 mL about 7.4 mL, about 7.5 mL, about 7.6 mL, about 7.7 mL, about 7.8 mL, about 7.9 mL, about 8 mL, about 8.1 mL, about 8.2 mL, about 8.3 mL, about 8.4 mL, about 8.5 mL, about 8.6 mL, about 8.7 mL, about 8.8 mL, about 8.9 mL, about 9 mL, about 9.1 mL, about 9.2 mL, about 9.3 mL, about 9.4 mL, about 9.5 mL, about 9.6 mL, about 9.7 mL, about 9.8 mL, about 9.9 mL, about 10 mL, about 10.1 mL, about 10.2 mL, about 10.3 mL, about 10.4 mL, about 10.5 mL, about 10.6 mL, about 10.7 mL, about 10.8 mL, about 10.9 mL, about 11 mL, about 11.1 mL, about 11.2 mL, about 11.3 mL, about 11.4 mL, about 11.5 mL, about 11.6 mL, about 11.7 mL, about 11.8 mL, about 11.9 mL, about 12 mL, about 12.1 mL, about 12.2 mL, about 12.3 mL, about 12.4 mL, about 12.5 mL, about 12.6 mL, about 12.7 mL, about 12.8 mL, about 12.9 mL, about 13 mL, about 13.1 mL, about 13.2 mL, about 13.3 mL, about 13.4 mL, about 13.5 mL, about 13.6 mL, about 13.7 mL, about 13.8 mL, about 13.9 mL, about 14 mL, about 14.1 mL, about 14.2 mL, about 14.3 mL, about 14.4 mL, about 14.5 mL, about 14.6 mL, about 14.7 mL, about 14.8 mL, about 14.9 mL, about 15 mL, about 15.1 mL, about 15.2 mL, about 15.3 mL, about 15.4 mL, about 15.5 mL, about 15.6 mL, about 15.7 mL, about 15.8 mL, about 15.9 mL, about 16 mL, about 16.1 mL, about 16.2 mL, about 16.3 mL, about 16.4 mL, about 16.5 mL, about 16.6 mL, about 16.7 mL, about 16.8 mL, about 16.9 mL about 17 mL, about 17.1 mL, about 17.2 mL, about 17.3 mL, about 17.4 mL, about 17.5 mL, about 17.6 mL, about 17.7 mL, about 17.8 mL, about 17.9 mL, about 18 mL, about 18.1 mL, about 18.2 mL, about 18.3 mL, about 18.4 mL, about 18.5 mL, about 18.6 mL, about 18.7 mL, about 18.8 mL, about 18.9 mL, about 19 mL, about 19.1 mL, about 19.2 mL, about 19.3 mL, about 19.4 mL, about 19.5 mL, about 19.6 mL, about 19.7 mL, DB1 / 155561236.2 39 about 19.8 mL, about 19.9 mL, about 20 mL, about 20.1 mL, about 20.2 mL, about 20.3 mL, about 20.4 mL, about 20.5 mL, about 20.6 mL, about 20.7 mL, about 20.8 mL, about 20.9 mL, about 21 mL, about 21.1 mL, about 21.2 mL, about 21.3 mL, about 21.4 mL, about 21.5 mL, about 21.6 mL, about 21.7 mL, about 21.8 mL, about 21.9 mL, about 22 mL, about 22.1 mL, about 22.2 mL, about 22.3 mL, about 22.4 mL, about 22.5 mL, about 22.6 mL, about 22.7 mL, about 22.8 mL, about 22.9 mL, about 23 mL, about 23.1 mL, about 23.2 mL, about 23.3 mL, about 23.4 mL, about 23.5 mL, about 23.6 mL, about 23.7 mL, about 23.8 mL, about 23.9 mL, about 24 mL, about 24.1 mL, about 24.2 mL, about 24.3 mL, about 24.4 mL, about 24.5 mL, about 24.6 mL, about 24.7 mL, about 24.8 mL, about 24.9 mL, or about 25 mL to the animal subject. Clause 17. The method of any one of clauses 1-9, 13, or 15, comprising administering about 3 mL, about 3.1 mL, about 3.2 mL, about 3.4 mL, about 3.5 mL, about 3.6 mL, about 3.7 mL, about 3.8 mL, about 3.9 mL, about 4 mL, about 4.1 mL, about 4.2 mL, about 4.3 mL, about 4.4 mL, about 4.5 mL, about 5 mL, about 5.1 mL, about 5.2 mL, about 5.3 mL, about 5.4 mL, about 5.5 mL, about 5.6 mL, about 5.7 mL, about 5.8 mL, about 5.9 mL, about 6 mL, about 6.1 mL, about 6.2 mL, about 6.3 mL, about 6.4 mL, about 6.5 mL, about 6.6 mL, about 6.7 mL, about 6.8 mL, about 6.9 mL, about 7 mL, about 7.1 mL, about 7.2 mL, about 7.3 mL about 7.4 mL, about 7.5 mL, about 7.6 mL, about 7.7 mL, about 7.8 mL, about 7.9 mL, about 8 mL, about 8.1 mL, about 8.2 mL, about 8.3 mL, about 8.4 mL, about 8.5 mL, about 8.6 mL, about 8.7 mL, about 8.8 mL, about 8.9 mL, about 9 mL, about 9.1 mL, about 9.2 mL, about 9.3 mL, about 9.4 mL, about 9.5 mL, about 9.6 mL, about 9.7 mL, about 9.8 mL, about 9.9 mL, about 10 mL, about 10.1 mL, about 10.2 mL, about 10.3 mL, about 10.4 mL, about 10.5 mL, about 10.6 mL, about 10.7 mL, about 10.8 mL, about 10.9 mL, about 11 mL, about 11.1 mL, about 11.2 mL, about 11.3 mL, about 11.4 mL, about 11.5 mL, about 11.6 mL, about 11.7 mL, about 11.8 mL, about 11.9 mL, about 12 mL, about 12.1 mL, about 12.2 mL, about 12.3 mL, about 12.4 mL, about 12.5 mL, about 12.6 mL, about 12.7 mL, about 12.8 mL, about 12.9 mL, about 13 mL, about 13.1 mL, about 13.2 mL, about 13.3 mL, about 13.4 mL, about 13.5 mL, about 13.6 mL, about 13.7 mL, about 13.8 mL, about 13.9 mL, about 14 mL, about 14.1 mL, about 14.2 mL, about 14.3 mL, about 14.4 mL, about 14.5 mL, about 14.6 mL, about 14.7 mL, about 14.8 mL, about 14.9 mL, about 15 mL, about 15.1 mL, about 15.2 mL, about 15.3 mL, about 15.4 mL, about 15.5 mL, about 15.6 mL, about 15.7 mL, about 15.8 mL, about 15.9 mL, about 16 mL, about 16.1 mL, about 16.2 mL, about 16.3 mL, about 16.4 mL, about 16.5 mL, about 16.6 mL, about 16.7 mL, about 16.8 mL, about 16.9 mL about 17 mL, about 17.1 mL, about 17.2 mL, about 17.3 mL, about 17.4 mL, about 17.5 mL, about 17.6 mL, about 17.7 mL, about 17.8 mL, about 17.9 mL, DB1 / 155561236.2 40 about 18 mL, about 18.1 mL, about 18.2 mL, about 18.3 mL, about 18.4 mL, about 18.5 mL, about 18.6 mL, about 18.7 mL, about 18.8 mL, about 18.9 mL, about 19 mL, about 19.1 mL, about 19.2 mL, about 19.3 mL, about 19.4 mL, about 19.5 mL, about 19.6 mL, about 19.7 mL, about 19.8 mL, about 19.9 mL, about 20 mL, about 20.1 mL, about 20.2 mL, about 20.3 mL, about 20.4 mL, about 20.5 mL, about 20.6 mL, about 20.7 mL, about 20.8 mL, about 20.9 mL, about 21 mL, about 21.1 mL, about 21.2 mL, about 21.3 mL, about 21.4 mL, about 21.5 mL, about 21.6 mL, about 21.7 mL, about 21.8 mL, about 21.9 mL, about 22 mL, about 22.1 mL, about 22.2 mL, about 22.3 mL, about 22.4 mL, about 22.5 mL, about 22.6 mL, about 22.7 mL, about 22.8 mL, about 22.9 mL, about 23 mL, about 23.1 mL, about 23.2 mL, about 23.3 mL, about 23.4 mL, about 23.5 mL, about 23.6 mL, about 23.7 mL, about 23.8 mL, about 23.9 mL, about 24 mL, about 24.1 mL, about 24.2 mL, about 24.3 mL, about 24.4 mL, about 24.5 mL, about 24.6 mL, about 24.7 mL, about 24.8 mL, about 24.9 mL, or about 25 mL to the human subject. Clause 18. The method of any one of clauses 1-17, wherein the formulation is in a prefilled syringe. Clause 19. The method of clause 18, wherein the prefilled syringe contains about 3 mL, about 3.1 mL, about 3.2 mL, about 3.4 mL, about 3.5 mL, about 3.6 mL, about 3.7 mL, about 3.8 mL, about 3.9 mL, about 4 mL, about 4.1 mL, about 4.2 mL, about 4.3 mL, about 4.4 mL, about 4.5 mL, about 5 mL, about 5.1 mL, about 5.2 mL, about 5.3 mL, about 5.4 mL, about 5.5 mL, about 5.6 mL, about 5.7 mL, about 5.8 mL, about 5.9 mL, about 6 mL, about 6.1 mL, about 6.2 mL, about 6.3 mL, about 6.4 mL, about 6.5 mL, about 6.6 mL, about 6.7 mL, about 6.8 mL, about 6.9 mL, about 7 mL, about 7.1 mL, about 7.2 mL, about 7.3 mL about 7.4 mL, about 7.5 mL, about 7.6 mL, about 7.7 mL, about 7.8 mL, about 7.9 mL, about 8 mL, about 8.1 mL, about 8.2 mL, about 8.3 mL, about 8.4 mL, about 8.5 mL, about 8.6 mL, about 8.7 mL, about 8.8 mL, about 8.9 mL, about 9 mL, about 9.1 mL, about 9.2 mL, about 9.3 mL, about 9.4 mL, about 9.5 mL, about 9.6 mL, about 9.7 mL, about 9.8 mL, about 9.9 mL, about 10 mL, about 10.1 mL, about 10.2 mL, about 10.3 mL, about 10.4 mL, about 10.5 mL, about 10.6 mL, about 10.7 mL, about 10.8 mL, about 10.9 mL, about 11 mL, about 11.1 mL, about 11.2 mL, about 11.3 mL, about 11.4 mL, about 11.5 mL, about 11.6 mL, about 11.7 mL, about 11.8 mL, about 11.9 mL, about 12 mL, about 12.1 mL, about 12.2 mL, about 12.3 mL, about 12.4 mL, about 12.5 mL, about 12.6 mL, about 12.7 mL, about 12.8 mL, about 12.9 mL, about 13 mL, about 13.1 mL, about 13.2 mL, about 13.3 mL, about 13.4 mL, about 13.5 mL, about 13.6 mL, about 13.7 mL, about 13.8 mL, about 13.9 mL, about 14 mL, about 14.1 mL, about 14.2 mL, about 14.3 mL, about 14.4 mL, about 14.5 mL, about 14.6 mL, about 14.7 mL, about 14.8 mL, about 14.9 mL, about 15 DB1 / 155561236.2 41 mL, about 15.1 mL, about 15.2 mL, about 15.3 mL, about 15.4 mL, about 15.5 mL, about 15.6 mL, about 15.7 mL, about 15.8 mL, about 15.9 mL, about 16 mL, about 16.1 mL, about 16.2 mL, about 16.3 mL, about 16.4 mL, about 16.5 mL, about 16.6 mL, about 16.7 mL, about 16.8 mL, about 16.9 mL about 17 mL, about 17.1 mL, about 17.2 mL, about 17.3 mL, about 17.4 mL, about 17.5 mL, about 17.6 mL, about 17.7 mL, about 17.8 mL, about 17.9 mL, about 18 mL, about 18.1 mL, about 18.2 mL, about 18.3 mL, about 18.4 mL, about 18.5 mL, about 18.6 mL, about 18.7 mL, about 18.8 mL, about 18.9 mL, about 19 mL, about 19.1 mL, about 19.2 mL, about 19.3 mL, about 19.4 mL, about 19.5 mL, about 19.6 mL, about 19.7 mL, about 19.8 mL, about 19.9 mL, about 20 mL, about 20.1 mL, about 20.2 mL, about 20.3 mL, about 20.4 mL, about 20.5 mL, about 20.6 mL, about 20.7 mL, about 20.8 mL, about 20.9 mL, about 21 mL, about 21.1 mL, about 21.2 mL, about 21.3 mL, about 21.4 mL, about 21.5 mL, about 21.6 mL, about 21.7 mL, about 21.8 mL, about 21.9 mL, about 22 mL, about 22.1 mL, about 22.2 mL, about 22.3 mL, about 22.4 mL, about 22.5 mL, about 22.6 mL, about 22.7 mL, about 22.8 mL, about 22.9 mL, about 23 mL, about 23.1 mL, about 23.2 mL, about 23.3 mL, about 23.4 mL, about 23.5 mL, about 23.6 mL, about 23.7 mL, about 23.8 mL, about 23.9 mL, about 24 mL, about 24.1 mL, about 24.2 mL, about 24.3 mL, about 24.4 mL, about 24.5 mL, about 24.6 mL, about 24.7 mL, about 24.8 mL, about 24.9 mL, or about 25 mL of the formulation. Clause 20. The method of clause 18 or 19, wherein the prefilled syringe comprises a needle having a gauge of about 20 to about 33. Clause 21. The method of any one of clauses 18-20, wherein the prefilled syringe comprises a 20 gauge needle, a 21 gauge needle, a 22 gauge needle, a 23 gauge needle, a 24 gauge needle, a 25 gauge needle, a 26 gauge needle, a 27 gauge needle, a 28 gauge needle, a 29 gauge needle, a 30 gauge needle, a 31 gauge needle, a 32 gauge needle, or a 33 gauge needle. Clause 22. The method of any one of clauses 1-12, 14, or 16, comprising administering the formulation to the animal subject at a rate of about 0.08 mL / sec to about 1.00 mL / sec. Clause 23. The method of any one of clauses 1-9, 13, 15, or 17, comprising administering the formulation to the human subject at a rate of about 0.08 mL / sec to about 1.00 mL / sec. Clause 24. The method of any one of clauses 1-12, 14, 16, or 22, comprising administering the formulation to the animal subject at a rate of at least about 0.08 mL / sec to about 1.0 mL / sec. Clause 25. The method of any one of clauses 1-9, 13, 15, 17, or 23, comprising administering the formulation to the human subject at a rate of at least about 0.08 mL / sec to about 1.0 mL / sec. Clause 26. The method of any one of clauses 1-12, 14, or 16, comprising administering the formulation to the animal subject at a rate of at least or faster than about 0.08 mL / sec to about 1.00 mL / sec. DB1 / 155561236.2 42 Clause 27. The method of any one of clauses 1-9, 13, 15, or 17, comprising administering the formulation to the human subject at a rate of at least or faster than about 0.08 mL / sec to about 1.00 mL / sec. Clause 28. The method of any one of clauses 1-12, 14, 16, 22, or 24, wherein administering the formulation to the animal subject takes about 10 seconds to about 40 seconds. Clause 29. The method of any one of clauses 1-9, 13, 15, 17, 23, or 25, wherein administering the formulation to the human subject takes about 10 seconds to about 40 seconds. Clause 30. The method of any one of clauses 1-12, 14, 16, 22, or 24, wherein administering the formulation to the animal subject takes at least about 10 seconds to about 40 seconds. Clause 31. The method of any one of clauses 1-9, 13, 15, 17, 23, or 25, wherein administering the formulation to the human subject takes at least about 10 seconds to about 40 seconds. Clause 32. The method of any one of clauses 1-12, 14, 16, 22, or 24, wherein administering the formulation to the animal subject takes at least or less than about 10 seconds to about 40 seconds. Clause 33. The method of any one of clauses 1-9, 13, 15, 17, 23, or 25, wherein administering the formulation to the human subject takes at least or less than about 10 seconds to about 40 seconds. Clause 34. The method of any one of clauses 1-12, 14, 16, 22, or 24, wherein administering the formulation to the animal subject takes about 15 seconds to about 30 seconds. Clause 35. The method of any one of clauses 1-9, 13, 15, 17, 23, or 25, wherein administering the formulation to the human subject takes about 15 seconds to about 30 seconds. Clause 36. The method of any one of clauses 1-12, 14, 16, 22, or 24, wherein administering the formulation to the animal subject takes at least about 15 seconds to about 30 seconds. Clause 37. The method of any one of clauses 1-9, 13, 15, 17, 23, or 25, wherein administering the formulation to the human subject takes at least about 15 seconds to about 30 seconds. Clause 38. The method of any one of clauses 1-12, 14, 16, 22, or 24, wherein administering the formulation to the animal subject takes at least or less than about 15 seconds to about 30 seconds. Clause 39. The method of any one of clauses 1-9, 13, 15, 17, 23, or 25, wherein administering the formulation to the human subject takes at least or less than about 15 seconds to about 30 seconds. Clause 40. The method any one of clauses 1-12, 14, 16, 22, or 24, comprising administering about 10 mL of the formulation to the animal subject at a rate of about 0.32 mL / sec to about 0.42 mL / sec. DB1 / 155561236.2 43 Clause 41. The method any one of clauses 1-9, 13, 15, 17, 23, or 25, comprising administering about 10 mL of the formulation to the human subject at a rate of about 0.32 mL / sec to about 0.42 mL / sec. Clause 42. The method of any one of clauses 1-41, wherein the parameter is injection force. Clause 43. The method of clause 42, wherein the animal subject is a miniature pig. Clause 44. The method of clause 42 or 43, wherein the animal subject is a Yucatan miniature pig. Clause 45. The method of any one of clauses 42-44, wherein the formulation further comprises gamma globulin. Clause 46. The method of any one of clauses 42-45, wherein the subcutaneous administration to the animal subject occurs via a high volume autoinjector fitted with a 25 gauge needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. Clause 47. The method of clause 42 or 45, wherein the subcutaneous administration to the human subject occurs via a high volume autoinjector fitted with a 25 gauge needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. Clause 48. The method of any one of clauses 42-47, comprising determining the injection force of the subcutaneous injection in the human subject by multiplying the measured injection force of the animal subject by a scaling factor. Clause 49. The method of clause 48, wherein the scaling factor is about 0.80 to about 0.99. Clause 50. The method of clause 48 or 49, wherein the scaling factor is about 0.85 to about 0.95; optionally about 0.88 to about 0.92. Clause 51. The method of any one of clauses 42-50, wherein the injection force is measured in Newtons (N). Clause 52. The method of any one of clauses 42-51, comprising: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.42 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the injection force of the subcutaneous injection in the miniature pig to be about 25 N to about 50 N; and determining the injection force of an identical subcutaneous injection in the human subject by multiplying the miniature pig injection force by a scaling factor of about 0.85 to about 0.95, obtaining an estimated injection force of about 21 N to about 48 N. DB1 / 155561236.2 44 Clause 53. The method of any one of clauses 42-52, comprising: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.36 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the injection force of the subcutaneous injection in the miniature pig to be about 40 N to about 46 N; and determining the injection force of an identical subcutaneous injection in the human subject by multiplying the miniature pig injection force by a scaling factor of about 0.88 to about 0.92, obtaining an estimated injection force of about 35 N to about 42 N. Clause 54. The method of any one of clauses 1-41, wherein the parameter is injection time. Clause 55. The method of clause 54, wherein the animal subject is a miniature pig. Clause 56. The method of clause 54 or 55, wherein the animal subject is a Yucatan miniature pig. Clause 57. The method of any one of clauses 54-56, wherein the formulation further comprises gamma globulin. Clause 58. The method of any one of clauses 54-57, wherein the subcutaneous administration to the animal subject occurs via a high volume autoinjector fitted with a 25 gauge needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. Clause 59. The method of clauses 54 or 57, wherein the subcutaneous administration to the human subject occurs via a high volume autoinjector fitted with a 25 gauge needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. Clause 60. The method of any one of clauses 54-59, comprising determining the injection time of the subcutaneous injection in the human subject by multiplying the measured injection time of the animal subject by a scaling factor. Clause 61. The method of clause 60, wherein the scaling factor is about 0.80 to about 0.99. Clause 62. The method of clause 60 or 61, wherein the scaling factor is about 0.85 to about 0.95; optionally about 0.88 to about 0.92. Clause 63. The method of any one of clauses 54-62, wherein the injection time is measured in seconds. Clause 64. The method of any one of clauses 54-63, comprising: DB1 / 155561236.2 45 administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.36 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the injection time of the subcutaneous injection in the miniature pig to be about 15 seconds to about 35 seconds; and determining the injection time of an identical subcutaneous injection in the human subject by multiplying the miniature pig injection time by a scaling factor of about 0.85 to about 0.95, obtaining an estimated injection time of about 13 seconds to about 33 seconds. Clause 65. The method of any one of clauses 54-64, comprising: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.36 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the injection time of the subcutaneous injection in the miniature pig to be about 18 seconds to about 30 seconds; and determining the injection time of an identical subcutaneous injection in the human subject by multiplying the miniature pig injection time by a scaling factor of about 0.88 to about 0.92, obtaining an estimated injection time of about 16 seconds to about 28 seconds. Clause 66. The method of any one of clauses 1-41, wherein the parameter is injection site reaction data. Clause 67. The method of clause 66, wherein the injection site reaction data comprises one or more of back leakage at the injection site, swelling volume at the injection site, swelling height at the injection site, bleb swelling size at the injection site, bleb induration at the injection site, and bleb resolution at the injection site. Clause 68. The method of clause 66 or 67, wherein the animal subject is a miniature pig. Clause 69. The method of any one of clauses 66-68, wherein the animal subject is a Yucatan miniature pig. Clause 70. The method of any one of clauses 66-69, wherein the formulation further comprises gamma globulin. Clause 71. The method of any one of clauses 66-70, wherein the subcutaneous administration to the animal subject occurs via a high volume autoinjector fitted with a 25 gauge needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. Clause 72. The method of any one of clauses 66, 67, or 70, wherein the subcutaneous administration to the human subject occurs via a high volume autoinjector fitted with a 25 gauge DB1 / 155561236.2 46 needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. Clause 73. The method of any one of clauses 66-72, comprising: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.42 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the one or more injection site reactions of the subcutaneous injection in the miniature pig and assigning a score from 0, 1, 2, 3, or 4; and determining that the one or more injection site reactions of an identical subcutaneous injection in the human subject will have the same score. Clause 74. The method of any one of clauses 66-73, comprising: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.36 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the one or more injection site reactions of the subcutaneous injection in the miniature pig and assigning a score from 0, 1, 2, 3, or 4; and determining that the one or more injection site reactions of an identical subcutaneous injection in the human subject will have the same score. Clause 75. The method of any one of clauses 66-71, 73, or 74, wherein the subcutaneous administration to the animal subject comprises a single injection. Clause 76. The method of any one of clauses 66, 67, 70, or 72-74, wherein the subcutaneous administration to the human subject comprises a single injection. Clause 77. The method of any one of clauses 66-71, 73, or 75, wherein the subcutaneous administration to the animal subject comprises two or more injections. Clause 78. The method of any one of clauses 66, 67, 69, or 71-73, wherein the subcutaneous administration to the human subject comprises two or more injections. EXAMPLES The following examples are included for illustrative purposes only and are not intended to limit the scope of the invention. Example 1: Miniature Pig as a Preclinical Model to Predict the Clinical Injection Times of a 10 mL High-Volume Auto-Injector (HVAI) with Recombinant Human Hyaluronidase (rHuPH20) DB1 / 155561236.2 47 Auto-injectors have now grown to hold volumes up to 10 mL; however, one limitation to rapid, bulk fluid flow is hyaluronan (HA) in the SC space. rHuPH20 depolymerizes HA to transiently reduce this barrier and tissue back-pressure, enabling high-volume, rapid SC injections. We have developed a clinic-ready 10 mL HVAI, and assessed it use in an animal model that could predictively translate preclinical findings to human injection time outcome utilizing rHuPH20. 10 mL of GGL with rHuPH20 was injected in 30 seconds using a pump, syringe, and 25G needle (BD or Terumo) into mini-pigs. A load-cell measured injection forces of 67.4 and 42.6 N for BD and Terumo needles, respectively. This was then repeated using the HVAI, with the same two needles, in the mini-pig to determine mean injection times of 30.0 and 19.8 seconds, respectively. The clinical trial initiated using the same pump, syringe, and Terumo 25G needle. Injection forces were measured to be 38.7 N for the same 10 mL, 30 second SC injection. Based on these data, it was calculated that the predicted time for injection with the HVAI in humans was 27.2 seconds. The clinical trial resulted in an injection time of 27.9 seconds. The duration of each injection was measured and recorded. Additional endpoints included measurement of post-injection back-leakage, local injection site measurements (bleb area and volume), qualitative scoring assessment of the local tissue for erythema, swelling size and induration, and standard imaging to quantitate post-injection changes of the skin. Assembly of all devices occurred in a sterile fill and finish hood under aseptic conditions. COC syringes were used to contain test solutions in the HVAI device. Springs used in this study had the same k spring constant as the devices used in a previous study using the HVAI (Studies 22148 and 23027). Prior to final assembly COC syringes were brought to room temperature for at least 30 minutes. The syringe cap was removed and replaced with a 25G x 1-inch Becton Dickinson needle and loaded into a jig where the HVAI was assembled by Halozyme engineering staff. After final assembly of the HVAI a needle guard was placed over the needle to bring the exposed needle depth to 10 mm ± 1 mm. The length of each needle was recorded. Animal Description Species: Pig (Sus scrofa domestica) Strain: Yucatan miniature Sex: Female Age: ~4-6 months Body weight: ~18-22 kg Quantity: 3 Source: Premier BioSource (Ramona, CA) DB1 / 155561236.2 48 Husbandry: The animals were housed in steel pens with automatic water provided ad libitum. The animals were fed twice daily (AM and PM) but kept NPO after midnight on the day of the study to prevent anesthesia complications. The room environment was set to maintain a temperature of ~ 19-23°C and a relative humidity of 40-70%, with a 12-hour light / 12-hour dark time cycle. The animals were acclimated to the vivarium for a minimum of 3 days prior to study start. Test Materials Table 1. Summary of test materials Test Material Supplier Catalog # High Volume Auto-Injector (HVAI) Halozyme N / A COC syringes SCHOTT, Inc. N / A Sterile rubber plunger for COC syringes SCHOTT, Inc. N / A Rubber plunger positioning platform Halozyme N / A Syringe caps Becton Dickinson 305819 25G x 1 inch Precision Glide needle Becton Dickinson 305125 Surgical Eye Spears BVI Merocel®400101 Standard Digital Camera Canon S120 Digital Caliper Fisher 06-664-16 12 mm biopsy punch Accuderm NC9253254 10% neutral buffered formalin Fisher Scientific 22-026-435 The duration of the injection was measured using a hand-held stopwatch (Fisher). Following administration any back-leakage was collected for a period of 30 seconds and weighed using an analytical balance with a sensitivity of 0.1 mg. Qualitative assessments and photographic images were taken immediately post-injection. Study Procedure Prior to the start of study, the animals were assessed for general health, and body weights collected. All anesthesia was administered and monitored. One day prior to the study, syringes were filled with appropriate test solutions and assembled into HVAIs then stored at 2-8°C. Devices were allowed to acclimate to room temperature for at least 30 minutes prior to use and used within 2 hours. After anesthetization the animal was placed in dorsal recumbence on a heated surgical table and was maintained under isoflurane gas for the entire duration of the procedure. Following anesthetization, the abdominal region was cleaned with Nolvasan followed by wiping the injection site with gauze containing 70% isopropanol and wiped dry with sterile DB1 / 155561236.2 49 gauze. Injection sites were located on the left and right abdominal regions, ~5 cm cranially from the inguinal fold towards the midline and ~3 cm towards the midline of the animal. Each of the injection sites were marked with a permanent marker and then photographed with the standard and 3D cameras prior to needle insertion. Once injections were completed, two additional devices were brought to room temperature for use with the next animal. The needle was inserted vertically into the marked injection site and the HVAI held in place by hand. Target needle insertion depth was ~10 mm. Injections were timed using a stopwatch. Upon completion of the injection the needle was removed and the HVAI device discarded. Test solution back-leakage was then absorbed to a tared eye-spear for 30 seconds on the injection site and the weight of the eye spear was measured using an analytical balance. The margins of the injection site bleb were marked with a permanent marker and measured for length, width, and height using a digital caliper and recorded then photographed with the standard and 3D cameras. Caliper measurements and photographs were taken immediately post- injection. Local injection sites were qualitatively assessed and graded daily for erythema severity, swelling size appearance, and firmness, using a scoring system described in Table 4 Table 5, and Table 6, respectively. Table 4. Grading scale for erythema formation Scale Description 0 No erythema 1 Very slight erythema (barely perceptible) 2 Well defined erythema 3 Moderate to severe erythema 4 Severe erythema (beet redness) to slight eschar formation Table 5. Grading scale for swelling formation Scale Description 0 No swelling 1 Very slight swelling 2 Slight swelling 3 Moderate swelling 4 Severe swelling Table 6. Grading scale for swelling firmness (induration) Scale Description 0 No perceptible difference in firmness after injection DB1 / 155561236.2 50 1 Very slightly firm (barely perceptible) 2 Mildly firm 3 Moderately firm 4 Very firm Approximately, 24 hours post-dosing of the first injection, each animal was re- anesthetized, and injection sites assessed for erythema, induration and swelling, then photographed and returned to its cage. Following the assessment after day three, the animal was humanely euthanized using an injectable euthanasia drug provided by the vivarium staff. Following euthanasia full thickness punch biopsies of the injection site were taken (12 mm) and placed in 10 % formalin. After obtaining the punch biopsies the animal carcass was removed and disposed of as biohazardous waste. Sections were made from tissue samples and assessed for histopathology using hematoxylin and eosin staining methods. Analyses were performed on each injection site (2 biopsies) and one untreated site. Three tissue depths were examined from each tissue section following level sectioning technique, representing the beginning, middle and end of each section. Calculations And Statistical Methods Assessment of Injection Time The duration of the injection was measured using a digital stopwatch with resolution of 0.1 seconds. Assessment of Local Swelling Volume and Area Using Caliper Measurement and 3D Imaging Volume and area of post-injection swelling were measured using both caliper measurement and 3D camera image analysis. For caliper measurements a digital caliper was utilized to measure length, width and height of the bleb that formed post-injection. The length and width are defined as the edge to edge measurements of the bleb (i.e., diameter) along their longest axes. These values were manually recorded, and the volume determined using the formula for half of an ellipsoid Vol = (2 / 3)*π*A*B*C where A = Length / 2, B = Width / 2 and C = Height. 3D imaging was applied as a longitudinal methodology to measure post-injection swelling. By obtaining high definition pre- and post-injection 3D images the distances between two registered surfaces can be determined. The camera captures images using a factory calibrated bifocal imaging system to measure distance between surfaces. Surface registration was performed using a multipoint method that utilized common landmarks between the pre-injection DB1 / 155561236.2 51 image and the post-injection image. Using the proprietary software, the volume, area and height of the post- injection swelling was calculated for each injection (Canfield Biosciences, Inc.). Caliper measurement and 3D imaging measurement yield different values for volume, area, and bleb height. The differences are a result of the difference in the bleb size measurement. The 3D measurement calculates bleb height based on the top of the bleb to the original skin position, while the bleb height from caliper measurements measure from the top of the bleb to the height at the edge of the bleb. Due to skin curvature, this may yield an overall increase in bleb height for the caliper measurements compared to the 3D measurements, resulting in greater bleb volume and height. However, the measurements are consistent with each other and therefore differ only due to the methodology. Quantitative measurements were taken immediately post-injection (T0) and daily afterwards up to ~72 hours. Duration of Injection The back-leakage was collected using a pre-weighed eye spear for 30 seconds post- injection. The eye spear was then re-weighed, and the weight of the back-leakage recorded. The local injection site swelling (bleb) was marked and measured using a digital caliper. Pre- and post-injection photographs were taken using a 3D imaging system (Canfield Scientific). This technology permits point-to-point alignment of these two images through multipoint surface registration. The distance between any two points is then represented using a colorimetric surface contour map. Regions where there is no difference between the two images are displayed in gray. Where the post-injection image is higher than the pre-injection image, the region is displayed in shades of blue. Where the post-injection image is lower than the pre-injection image the distance is displayed in shades of orange. The color intensity is proportional to the amount of distance measured between images with darker blue color indicating greater distance from the pre- injection image. Out of range measurements (distances greater than 6 mm) are depicted in white. Bleb measurements of volume and height include regions out of range. Each animal had a pre-injection 3D image taken of the injection site followed by a second image taken immediately post-injection and these images were mapped to each other using multipoint registration. These registered pre- / post-injection images were then used to calculate the bleb volume, height, circumference, length, and width for each bleb using proprietary software (Vectra H1 software; Canfield Sciences). Qualitative assessments were taken immediately post-injection (T0) and daily thereafter. No erythema, swelling or induration was detected on D1, D2 or D3 post-injection. DB1 / 155561236.2 52 O W)- c5 e2 s(15- D5t9a B- *s2e3..0m9sGi--- ---±3e 4T - -0.60 ul)52 60aN( no2V Fn iitcAm / ejndIeLtc mo IA ej 0o2muV rrPe *8T.H d--^0. -- -0 e- -8- - G4 tc15ejl2 oarir PTlacini)D1.8.lCniMB-2D±---0.1±am / ESG5N4.7-030.4ni L±2 6 5emNzil0(it2ecu: rlB oli t orFm 6 1wo )0.Ihdoeiulr.e0.1± ±%8 %28.1±Ap TV Cp -7.6. .0.99 4AG8 29-( 1 .7 3H3 4 3 5e5h2ttahtem6i.4.t)D fn MBoi -0±D -- -0- ±tmESG5 1.N - - - -2.n / uL±22362omNma 0(e1eh:crtAogtrF ondim 3.3toahoeil uriCpe0.0±D --- ---±mptT-4N- -0.s A e G.50 022 2rofsnoitBal& gi gpoluai–p e )mcceAFAin Hol ielcarTs()Cutoro– im:ea n y ria:S h2 aoeni cn H.oitdut(Cmy d er svce s hc 2.et zla 5pD0oe1lr ef5jngi naus fai0D1- IIpie 63nB216m -He 4Ai 5a 45x 0m %0V m51E1 1H / 1BD Bolded data was generated from a human clinical trial. When the 25G-Terumo needle was used in the Preclinical Study, the applied force was measured at 42.6 ± 1.1 (N ± SEM). However, the measured values for the clinical trial at this same flow rate were 10% lower. This can be calculated as: % Decrease = 100 - (38.7)*100 / 42.6) = -9.15% (~90.85% of the value measured in the pig study) Therefore, the predicted time for the HVAI injection using the 25G-Terumo needle would be: 25G-Terumo: 90.85% * 19.8 sec = 18.0 sec 25G-BDL 90.85% * 30.0 sec = 27.5 sec Based upon these estimates, it is recommended that the 25G-BD needle set be used for testing the HVAI device in Injection Visit #2 of the Halozyme 104-105 clinical trial. Projected AF values are calculated by multiplying the values from 104-105 – Cohort A by 2x because the Hagen-Poiseuille equation predicts that pressure will increase directly proportional to the flow rate. Therefore, since P = F / A, the applied force should increase 2x when the flow rate is increased by 2x. Projected HVAI Injection times are calculated by multiplying the values from the preclinical mini-pig study (bold) x 90.8%. Example 3 FIGS.1A-1B contain data with different needle gauges for the injection of 10 mL of GGL + rHuPH20 in mini-pigs. The needle gauge selection was used to control injection times. FIG.1A contains data obtained using a syringe pump. FIG.1B contains data obtained using an HVAI. FIG.2 provides data from a human study demonstrating that the mini-pig model may predict human injection times for HVAI. The data was obtained from a study of humans (Part B) injected with 10 mL over 30 seconds. A comparison of the applied force during injection between human and mini-pig provides a scaling factor as seen in the table below. Syringe Pump Applied Force (Mean ± SEM) Mini-pig (25G-TW) 42.6 ± 1.1 Human (25G-TW) 38.7 ± 0.6 Scaling factor 90.8% (-9.2%) DB1 / 155561236.2 54 The data from the mini-pig model predicted the HVAI injection times in humans (FIG.2 and table below). Preclinical data guided the choice of needle gauge for the human study to target 30 seconds. HVAI 25G-TW Time (sec) 25G Time (sec) Minipig 19.8 ± 0.5 30.0 ± 1.1 Projected Human (90.8%) 18.0 27.5 Measured Human --- 27.9 ± 0.8 FIGS.3A-3B contain data demonstrating that the mini-pig model can estimate injection site reactions for HVAI. FIG.3A provides the mini-pig injection site reaction data. FIG.3B provides the human injection site reaction data. DB1 / 155561236.2 55

Claims

CLAIMS 1. A method of determining one or more parameters of an injection of a formulation in a human subject, the method comprising: administering to an animal subject via subcutaneous injection from a high volume autoinjector about 3 mL to about 50 mL of a formulation comprising a therapeutically effective amount of a hyaluronidase enzyme; measuring one or more parameters of the subcutaneous injection in the animal subject; and determining the same one or more parameters of the subcutaneous injection in the human subject from the one or more measured parameters from the animal subject; wherein the one or more parameters are selected from injection time, injection force, and injection site reaction data.

2. The method of claim 1, the hyaluronidase enzyme is a soluble hyaluronidase enzyme.

3. The method of claim 1 or 2, wherein the hyaluronidase enzyme is a recombinant human hyaluronidase enzyme.

4. The method of any one of claims 1-3, wherein the hyaluronidase enzyme is a recombinant human hyaluronidase PH20 enzyme.

5. The method of claim 4, wherein the recombinant human hyaluronidase PH20 enzyme comprises a sequence having at least 95% amino acid sequence identity to an amino acid sequence of SEQ ID NO:

1.

6. The method of any one of claims 1-5, wherein the formulation further comprises a therapeutically effective amount of an active ingredient selected from a small molecule, a protein, a peptide fragment, a biologic, a nanoparticle, an antibody, an antibody fragment, and a small molecule antiviral.

7. The method of claim 6, wherein the antibody comprises a monoclonal antibody or a polyclonal antibody. DB1 / 155561236.2 568. The method of claim 7, wherein the monoclonal antibody or the polyclonal antibody comprises trastuzumab, rituximab, pertuzumab, atezolizumab, immune globulin, daratumumab, efgartigimod alfa, nivolumab, or ocrelizumab.

9. The method of claim 6, wherein the protein comprises gamma globulin.

10. The method of any one of claims 1-9, wherein the animal subject is a miniature pig.

11. The method of any one of claims 1-10, wherein the animal subject is a Yucatan miniature pig.

12. The method of any one of claims 1-11, comprising administering about 10 mL to about 20 mL of the formulation to the animal subject.

13. The method of any one of claims 1-9, comprising administering about 10 mL to about 20 mL of the formulation to the human subject.

14. The method of any one of claims 1-12, comprising administering about 3 mL to about 15 mL of the formulation to the animal subject.

15. The method of any one of claims 1-9 or 13, comprising administering about 3 mL to about 15 mL of the formulation to the human subject.

16. The method of any one of claims 1-12 or 14, comprising administering about 3 mL, about 3.1 mL, about 3.2 mL, about 3.4 mL, about 3.5 mL, about 3.6 mL, about 3.7 mL, about 3.8 mL, about 3.9 mL, about 4 mL, about 4.1 mL, about 4.2 mL, about 4.3 mL, about 4.4 mL, about 4.5 mL, about 5 mL, about 5.1 mL, about 5.2 mL, about 5.3 mL, about 5.4 mL, about 5.5 mL, about 5.6 mL, about 5.7 mL, about 5.8 mL, about 5.9 mL, about 6 mL, about 6.1 mL, about 6.2 mL, about 6.3 mL, about 6.4 mL, about 6.5 mL, about 6.6 mL, about 6.7 mL, about 6.8 mL, about 6.9 mL, about 7 mL, about 7.1 mL, about 7.2 mL, about 7.3 mL about 7.4 mL, about 7.5 mL, about 7.6 mL, about 7.7 mL, about 7.8 mL, about 7.9 mL, about 8 mL, about 8.1 mL, about 8.2 mL, about 8.3 mL, about 8.4 mL, about 8.5 mL, about 8.6 mL, about 8.7 mL, about 8.8 mL, about 8.9 mL, about 9 mL, about 9.1 mL, about 9.2 mL, about 9.3 mL, about 9.4 mL, about 9.5 mL, about 9.6 mL, about 9.7 mL, about 9.8 mL, about 9.9 mL, about 10 mL, about 10.1 mL, about 10.2 DB1 / 155561236.2 57mL, about 10.3 mL, about 10.4 mL, about 10.5 mL, about 10.6 mL, about 10.7 mL, about 10.8 mL, about 10.9 mL, about 11 mL, about 11.1 mL, about 11.2 mL, about 11.3 mL, about 11.4 mL, about 11.5 mL, about 11.6 mL, about 11.7 mL, about 11.8 mL, about 11.9 mL, about 12 mL, about 12.1 mL, about 12.2 mL, about 12.3 mL, about 12.4 mL, about 12.5 mL, about 12.6 mL, about 12.7 mL, about 12.8 mL, about 12.9 mL, about 13 mL, about 13.1 mL, about 13.2 mL, about 13.3 mL, about 13.4 mL, about 13.5 mL, about 13.6 mL, about 13.7 mL, about 13.8 mL, about 13.9 mL, about 14 mL, about 14.1 mL, about 14.2 mL, about 14.3 mL, about 14.4 mL, about 14.5 mL, about 14.6 mL, about 14.7 mL, about 14.8 mL, about 14.9 mL, about 15 mL, about 15.1 mL, about 15.2 mL, about 15.3 mL, about 15.4 mL, about 15.5 mL, about 15.6 mL, about 15.7 mL, about 15.8 mL, about 15.9 mL, about 16 mL, about 16.1 mL, about 16.2 mL, about 16.3 mL, about 16.4 mL, about 16.5 mL, about 16.6 mL, about 16.7 mL, about 16.8 mL, about 16.9 mL about 17 mL, about 17.1 mL, about 17.2 mL, about 17.3 mL, about 17.4 mL, about 17.5 mL, about 17.6 mL, about 17.7 mL, about 17.8 mL, about 17.9 mL, about 18 mL, about 18.1 mL, about 18.2 mL, about 18.3 mL, about 18.4 mL, about 18.5 mL, about 18.6 mL, about 18.7 mL, about 18.8 mL, about 18.9 mL, about 19 mL, about 19.1 mL, about 19.2 mL, about 19.3 mL, about 19.4 mL, about 19.5 mL, about 19.6 mL, about 19.7 mL, about 19.8 mL, about 19.9 mL, about 20 mL, about 20.1 mL, about 20.2 mL, about 20.3 mL, about 20.4 mL, about 20.5 mL, about 20.6 mL, about 20.7 mL, about 20.8 mL, about 20.9 mL, about 21 mL, about 21.1 mL, about 21.2 mL, about 21.3 mL, about 21.4 mL, about 21.5 mL, about 21.6 mL, about 21.7 mL, about 21.8 mL, about 21.9 mL, about 22 mL, about 22.1 mL, about 22.2 mL, about 22.3 mL, about 22.4 mL, about 22.5 mL, about 22.6 mL, about 22.7 mL, about 22.8 mL, about 22.9 mL, about 23 mL, about 23.1 mL, about 23.2 mL, about 23.3 mL, about 23.4 mL, about 23.5 mL, about 23.6 mL, about 23.7 mL, about 23.8 mL, about 23.9 mL, about 24 mL, about 24.1 mL, about 24.2 mL, about 24.3 mL, about 24.4 mL, about 24.5 mL, about 24.6 mL, about 24.7 mL, about 24.8 mL, about 24.9 mL, or about 25 mL to the animal subject.

17. The method of any one of claims 1-9, 13, or 15, comprising administering about 3 mL, about 3.1 mL, about 3.2 mL, about 3.4 mL, about 3.5 mL, about 3.6 mL, about 3.7 mL, about 3.8 mL, about 3.9 mL, about 4 mL, about 4.1 mL, about 4.2 mL, about 4.3 mL, about 4.4 mL, about 4.5 mL, about 5 mL, about 5.1 mL, about 5.2 mL, about 5.3 mL, about 5.4 mL, about 5.5 mL, about 5.6 mL, about 5.7 mL, about 5.8 mL, about 5.9 mL, about 6 mL, about 6.1 mL, about 6.2 mL, about 6.3 mL, about 6.4 mL, about 6.5 mL, about 6.6 mL, about 6.7 mL, about 6.8 mL, about 6.9 mL, about 7 mL, about 7.1 mL, about 7.2 mL, about 7.3 mL about 7.4 mL, about 7.5 mL, about 7.6 mL, about 7.7 mL, about 7.8 mL, about 7.9 mL, about 8 mL, about 8.1 mL, about DB1 / 155561236.2 588.2 mL, about 8.3 mL, about 8.4 mL, about 8.5 mL, about 8.6 mL, about 8.7 mL, about 8.8 mL, about 8.9 mL, about 9 mL, about 9.1 mL, about 9.2 mL, about 9.3 mL, about 9.4 mL, about 9.5 mL, about 9.6 mL, about 9.7 mL, about 9.8 mL, about 9.9 mL, about 10 mL, about 10.1 mL, about 10.2 mL, about 10.3 mL, about 10.4 mL, about 10.5 mL, about 10.6 mL, about 10.7 mL, about 10.8 mL, about 10.9 mL, about 11 mL, about 11.1 mL, about 11.2 mL, about 11.3 mL, about 11.4 mL, about 11.5 mL, about 11.6 mL, about 11.7 mL, about 11.8 mL, about 11.9 mL, about 12 mL, about 12.1 mL, about 12.2 mL, about 12.3 mL, about 12.4 mL, about 12.5 mL, about 12.6 mL, about 12.7 mL, about 12.8 mL, about 12.9 mL, about 13 mL, about 13.1 mL, about 13.2 mL, about 13.3 mL, about 13.4 mL, about 13.5 mL, about 13.6 mL, about 13.7 mL, about 13.8 mL, about 13.9 mL, about 14 mL, about 14.1 mL, about 14.2 mL, about 14.3 mL, about 14.4 mL, about 14.5 mL, about 14.6 mL, about 14.7 mL, about 14.8 mL, about 14.9 mL, about 15 mL, about 15.1 mL, about 15.2 mL, about 15.3 mL, about 15.4 mL, about 15.5 mL, about 15.6 mL, about 15.7 mL, about 15.8 mL, about 15.9 mL, about 16 mL, about 16.1 mL, about 16.2 mL, about 16.3 mL, about 16.4 mL, about 16.5 mL, about 16.6 mL, about 16.7 mL, about 16.8 mL, about 16.9 mL about 17 mL, about 17.1 mL, about 17.2 mL, about 17.3 mL, about 17.4 mL, about 17.5 mL, about 17.6 mL, about 17.7 mL, about 17.8 mL, about 17.9 mL, about 18 mL, about 18.1 mL, about 18.2 mL, about 18.3 mL, about 18.4 mL, about 18.5 mL, about 18.6 mL, about 18.7 mL, about 18.8 mL, about 18.9 mL, about 19 mL, about 19.1 mL, about 19.2 mL, about 19.3 mL, about 19.4 mL, about 19.5 mL, about 19.6 mL, about 19.7 mL, about 19.8 mL, about 19.9 mL, about 20 mL, about 20.1 mL, about 20.2 mL, about 20.3 mL, about 20.4 mL, about 20.5 mL, about 20.6 mL, about 20.7 mL, about 20.8 mL, about 20.9 mL, about 21 mL, about 21.1 mL, about 21.2 mL, about 21.3 mL, about 21.4 mL, about 21.5 mL, about 21.6 mL, about 21.7 mL, about 21.8 mL, about 21.9 mL, about 22 mL, about 22.1 mL, about 22.2 mL, about 22.3 mL, about 22.4 mL, about 22.5 mL, about 22.6 mL, about 22.7 mL, about 22.8 mL, about 22.9 mL, about 23 mL, about 23.1 mL, about 23.2 mL, about 23.3 mL, about 23.4 mL, about 23.5 mL, about 23.6 mL, about 23.7 mL, about 23.8 mL, about 23.9 mL, about 24 mL, about 24.1 mL, about 24.2 mL, about 24.3 mL, about 24.4 mL, about 24.5 mL, about 24.6 mL, about 24.7 mL, about 24.8 mL, about 24.9 mL, or about 25 mL to the human subject.

18. The method of any one of claims 1-17, wherein the formulation is in a prefilled syringe.

19. The method of claim 18, wherein the prefilled syringe contains about 3 mL, about 3.1 mL, about 3.2 mL, about 3.4 mL, about 3.5 mL, about 3.6 mL, about 3.7 mL, about 3.8 mL, DB1 / 155561236.2 59about 3.9 mL, about 4 mL, about 4.1 mL, about 4.2 mL, about 4.3 mL, about 4.4 mL, about 4.5 mL, about 5 mL, about 5.1 mL, about 5.2 mL, about 5.3 mL, about 5.4 mL, about 5.5 mL, about 5.6 mL, about 5.7 mL, about 5.8 mL, about 5.9 mL, about 6 mL, about 6.1 mL, about 6.2 mL, about 6.3 mL, about 6.4 mL, about 6.5 mL, about 6.6 mL, about 6.7 mL, about 6.8 mL, about 6.9 mL, about 7 mL, about 7.1 mL, about 7.2 mL, about 7.3 mL about 7.4 mL, about 7.5 mL, about 7.6 mL, about 7.7 mL, about 7.8 mL, about 7.9 mL, about 8 mL, about 8.1 mL, about 8.2 mL, about 8.3 mL, about 8.4 mL, about 8.5 mL, about 8.6 mL, about 8.7 mL, about 8.8 mL, about 8.9 mL, about 9 mL, about 9.1 mL, about 9.2 mL, about 9.3 mL, about 9.4 mL, about 9.5 mL, about 9.6 mL, about 9.7 mL, about 9.8 mL, about 9.9 mL, about 10 mL, about 10.1 mL, about 10.2 mL, about 10.3 mL, about 10.4 mL, about 10.5 mL, about 10.6 mL, about 10.7 mL, about 10.8 mL, about 10.9 mL, about 11 mL, about 11.1 mL, about 11.2 mL, about 11.3 mL, about 11.4 mL, about 11.5 mL, about 11.6 mL, about 11.7 mL, about 11.8 mL, about 11.9 mL, about 12 mL, about 12.1 mL, about 12.2 mL, about 12.3 mL, about 12.4 mL, about 12.5 mL, about 12.6 mL, about 12.7 mL, about 12.8 mL, about 12.9 mL, about 13 mL, about 13.1 mL, about 13.2 mL, about 13.3 mL, about 13.4 mL, about 13.5 mL, about 13.6 mL, about 13.7 mL, about 13.8 mL, about 13.9 mL, about 14 mL, about 14.1 mL, about 14.2 mL, about 14.3 mL, about 14.4 mL, about 14.5 mL, about 14.6 mL, about 14.7 mL, about 14.8 mL, about 14.9 mL, about 15 mL, about 15.1 mL, about 15.2 mL, about 15.3 mL, about 15.4 mL, about 15.5 mL, about 15.6 mL, about 15.7 mL, about 15.8 mL, about 15.9 mL, about 16 mL, about 16.1 mL, about 16.2 mL, about 16.3 mL, about 16.4 mL, about 16.5 mL, about 16.6 mL, about 16.7 mL, about 16.8 mL, about 16.9 mL about 17 mL, about 17.1 mL, about 17.2 mL, about 17.3 mL, about 17.4 mL, about 17.5 mL, about 17.6 mL, about 17.7 mL, about 17.8 mL, about 17.9 mL, about 18 mL, about 18.1 mL, about 18.2 mL, about 18.3 mL, about 18.4 mL, about 18.5 mL, about 18.6 mL, about 18.7 mL, about 18.8 mL, about 18.9 mL, about 19 mL, about 19.1 mL, about 19.2 mL, about 19.3 mL, about 19.4 mL, about 19.5 mL, about 19.6 mL, about 19.7 mL, about 19.8 mL, about 19.9 mL, about 20 mL, about 20.1 mL, about 20.2 mL, about 20.3 mL, about 20.4 mL, about 20.5 mL, about 20.6 mL, about 20.7 mL, about 20.8 mL, about 20.9 mL, about 21 mL, about 21.1 mL, about 21.2 mL, about 21.3 mL, about 21.4 mL, about 21.5 mL, about 21.6 mL, about 21.7 mL, about 21.8 mL, about 21.9 mL, about 22 mL, about 22.1 mL, about 22.2 mL, about 22.3 mL, about 22.4 mL, about 22.5 mL, about 22.6 mL, about 22.7 mL, about 22.8 mL, about 22.9 mL, about 23 mL, about 23.1 mL, about 23.2 mL, about 23.3 mL, about 23.4 mL, about 23.5 mL, about 23.6 mL, about 23.7 mL, about 23.8 mL, about 23.9 mL, about 24 mL, about 24.1 mL, about 24.2 mL, about 24.3 mL, about 24.4 mL, about 24.5 mL, about 24.6 mL, about 24.7 mL, about 24.8 mL, about 24.9 mL, or about 25 mL of the formulation. DB1 / 155561236.2 6020. The method of claim 18 or 19, wherein the prefilled syringe comprises a needle having a gauge of about 20 to about 33.

21. The method of any one of claims 18-20, wherein the prefilled syringe comprises a 20 gauge needle, a 21 gauge needle, a 22 gauge needle, a 23 gauge needle, a 24 gauge needle, a 25 gauge needle, a 26 gauge needle, a 27 gauge needle, a 28 gauge needle, a 29 gauge needle, a 30 gauge needle, a 31 gauge needle, a 32 gauge needle, or a 33 gauge needle.

22. The method of any one of claims 1-12, 14, or 16, comprising administering the formulation to the animal subject at a rate of about 0.08 mL / sec to about 1.00 mL / sec.

23. The method of any one of claims 1-9, 13, 15, or 17, comprising administering the formulation to the human subject at a rate of about 0.08 mL / sec to about 1.00 mL / sec.

24. The method of any one of claims 1-12, 14, 16, or 22, comprising administering the formulation to the animal subject at a rate of at least about 0.08 mL / sec to about 1.0 mL / sec.

25. The method of any one of claims 1-9, 13, 15, 17, or 23, comprising administering the formulation to the human subject at a rate of at least about 0.08 mL / sec to about 1.0 mL / sec.

26. The method of any one of claims 1-12, 14, or 16, comprising administering the formulation to the animal subject at a rate of at least or faster than about 0.08 mL / sec to about 1.00 mL / sec.

27. The method of any one of claims 1-9, 13, 15, or 17, comprising administering the formulation to the human subject at a rate of at least or faster than about 0.08 mL / sec to about 1.00 mL / sec.

28. The method of any one of claims 1-12, 14, 16, 22, or 24, wherein administering the formulation to the animal subject takes about 10 seconds to about 40 seconds.

29. The method of any one of claims 1-9, 13, 15, 17, 23, or 25, wherein administering the formulation to the human subject takes about 10 seconds to about 40 seconds. DB1 / 155561236.2 6130. The method of any one of claims 1-12, 14, 16, 22, or 24, wherein administering the formulation to the animal subject takes at least about 10 seconds to about 40 seconds.

31. The method of any one of claims 1-9, 13, 15, 17, 23, or 25, wherein administering the formulation to the human subject takes at least about 10 seconds to about 40 seconds.

32. The method of any one of claims 1-12, 14, 16, 22, or 24, wherein administering the formulation to the animal subject takes at least or less than about 10 seconds to about 40 seconds.

33. The method of any one of claims 1-9, 13, 15, 17, 23, or 25, wherein administering the formulation to the human subject takes at least or less than about 10 seconds to about 40 seconds.

34. The method of any one of claims 1-12, 14, 16, 22, or 24, wherein administering the formulation to the animal subject takes about 15 seconds to about 30 seconds.

35. The method of any one of claims 1-9, 13, 15, 17, 23, or 25, wherein administering the formulation to the human subject takes about 15 seconds to about 30 seconds.

36. The method of any one of claims 1-12, 14, 16, 22, or 24, wherein administering the formulation to the animal subject takes at least about 15 seconds to about 30 seconds.

37. The method of any one of claims 1-9, 13, 15, 17, 23, or 25, wherein administering the formulation to the human subject takes at least about 15 seconds to about 30 seconds.

38. The method of any one of claims 1-12, 14, 16, 22, or 24, wherein administering the formulation to the animal subject takes at least or less than about 15 seconds to about 30 seconds.

39. The method of any one of claims 1-9, 13, 15, 17, 23, or 25, wherein administering the formulation to the human subject takes at least or less than about 15 seconds to about 30 seconds.

40. The method any one of claims 1-12, 14, 16, 22, or 24, comprising administering about 10 mL of the formulation to the animal subject at a rate of about 0.32 mL / sec to about 0.42 mL / sec. DB1 / 155561236.2 6241. The method any one of claims 1-9, 13, 15, 17, 23, or 25, comprising administering about 10 mL of the formulation to the human subject at a rate of about 0.32 mL / sec to about 0.42 mL / sec.

42. The method of any one of claims 1-41, wherein the parameter is injection force.

43. The method of claim 42, wherein the animal subject is a miniature pig.

44. The method of claim 42 or 43, wherein the animal subject is a Yucatan miniature pig.

45. The method of any one of claims 42-44, wherein the formulation further comprises gamma globulin.

46. The method of any one of claims 42-45, wherein the subcutaneous administration to the animal subject occurs via a high volume autoinjector fitted with a 25 gauge needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle.

47. The method of claim 42 or 45, wherein the subcutaneous administration to the human subject occurs via a high volume autoinjector fitted with a 25 gauge needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle.

48. The method of any one of claims 42-47, comprising determining the injection force of the subcutaneous injection in the human subject by multiplying the measured injection force of the animal subject by a scaling factor.

49. The method of claim 48, wherein the scaling factor is about 0.80 to about 0.

99.

50. The method of claim 48 or 49, wherein the scaling factor is about 0.85 to about 0.95; optionally about 0.88 to about 0.

92.

51. The method of any one of claims 42-50, wherein the injection force is measured in Newtons (N). DB1 / 155561236.2 6352. The method of any one of claims 42-51, comprising: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.42 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the injection force of the subcutaneous injection in the miniature pig to be about 25 N to about 50 N; and determining the injection force of an identical subcutaneous injection in the human subject by multiplying the miniature pig injection force by a scaling factor of about 0.85 to about 0.95, obtaining an estimated injection force of about 21 N to about 48 N.

53. The method of any one of claims 42-52, comprising: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.36 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the injection force of the subcutaneous injection in the miniature pig to be about 40 N to about 46 N; and determining the injection force of an identical subcutaneous injection in the human subject by multiplying the miniature pig injection force by a scaling factor of about 0.88 to about 0.92, obtaining an estimated injection force of about 35 N to about 42 N.

54. The method of any one of claims 1-41, wherein the parameter is injection time.

55. The method of claim 54, wherein the animal subject is a miniature pig.

56. The method of claim 54 or 55, wherein the animal subject is a Yucatan miniature pig.

57. The method of any one of claims 54-56, wherein the formulation further comprises gamma globulin.

58. The method of any one of claims 54-57, wherein the subcutaneous administration to the animal subject occurs via a high volume autoinjector fitted with a 25 gauge needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle. DB1 / 155561236.2 6459. The method of claims 54 or 57, wherein the subcutaneous administration to the human subject occurs via a high volume autoinjector fitted with a 25 gauge needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle.

60. The method of any one of claims 54-59, comprising determining the injection time of the subcutaneous injection in the human subject by multiplying the measured injection time of the animal subject by a scaling factor.

61. The method of claim 60, wherein the scaling factor is about 0.80 to about 0.

99.

62. The method of claim 60 or 61, wherein the scaling factor is about 0.85 to about 0.95; optionally about 0.88 to about 0.

92.

63. The method of any one of claims 54-62, wherein the injection time is measured in seconds.

64. The method of any one of claims 54-63, comprising: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.36 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the injection time of the subcutaneous injection in the miniature pig to be about 15 seconds to about 35 seconds; and determining the injection time of an identical subcutaneous injection in the human subject by multiplying the miniature pig injection time by a scaling factor of about 0.85 to about 0.95, obtaining an estimated injection time of about 13 seconds to about 33 seconds.

65. The method of any one of claims 54-64, comprising: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.36 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the injection time of the subcutaneous injection in the miniature pig to be about 18 seconds to about 30 seconds; and DB1 / 155561236.2 65determining the injection time of an identical subcutaneous injection in the human subject by multiplying the miniature pig injection time by a scaling factor of about 0.88 to about 0.92, obtaining an estimated injection time of about 16 seconds to about 28 seconds.

66. The method of any one of claims 1-41, wherein the parameter is injection site reaction data.

67. The method of claim 66, wherein the injection site reaction data comprises one or more of back leakage at the injection site, swelling volume at the injection site, swelling height at the injection site, bleb swelling size at the injection site, bleb induration at the injection site, and bleb resolution at the injection site.

68. The method of claim 66 or 67, wherein the animal subject is a miniature pig.

69. The method of any one of claims 66-68, wherein the animal subject is a Yucatan miniature pig.

70. The method of any one of claims 66-69, wherein the formulation further comprises gamma globulin.

71. The method of any one of claims 66-70, wherein the subcutaneous administration to the animal subject occurs via a high volume autoinjector fitted with a 25 gauge needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle.

72. The method of any one of claims 66, 67, or 70, wherein the subcutaneous administration to the human subject occurs via a high volume autoinjector fitted with a 25 gauge needle, optionally via a high volume autoinjector that dispenses the formulation from a prefilled syringe fitted with a 25 gauge needle.

73. The method of any one of claims 66-72, comprising: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.42 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; DB1 / 155561236.2 66measuring the one or more injection site reactions of the subcutaneous injection in the miniature pig and assigning a score from 0, 1, 2, 3, or 4; and determining that the one or more injection site reactions of an identical subcutaneous injection in the human subject will have the same score.

74. The method of any one of claims 66-73, comprising: administering to a miniature pig animal subject via subcutaneous injection about 10 mL of the formulation at a rate of about 0.30 mL / sec to about 0.36 mL / sec with a high volume autoinjector dispensing the formulation from a prefilled syringe fitted with a 25 gauge needle; measuring the one or more injection site reactions of the subcutaneous injection in the miniature pig and assigning a score from 0, 1, 2, 3, or 4; and determining that the one or more injection site reactions of an identical subcutaneous injection in the human subject will have the same score.

75. The method of any one of claims 66-71, 73, or 74, wherein the subcutaneous administration to the animal subject comprises a single injection.

76. The method of any one of claims 66, 67, 70, or 72-74, wherein the subcutaneous administration to the human subject comprises a single injection.

77. The method of any one of claims 66-71, 73, or 75, wherein the subcutaneous administration to the animal subject comprises two or more injections.

78. The method of any one of claims 66, 67, 69, or 71-73, wherein the subcutaneous administration to the human subject comprises two or more injections. DB1 / 155561236.2 67

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