Method of preparing an antibody pharmaceutical formulation

Abstract

The present disclosure provides materials and methods for preparing an antibody pharmaceutical formulation having a viscosity of 10 cP or less comprising exchanging a composition comprising the antigen binding protein with a diafiltration buffer comprising calcium at a temperature greater than 30 DEG C.

Description

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 717,357, filed August 10, 2018, the disclosure of which is incorporated herein by reference in its entirety. [0002] Incorporation by reference of electronically submitted material [0003] Incorporated by reference in its entirety is the computer-readable nucleotide / amino acid sequence listing filed concurrently with this document, identified as follows: ASCII (text) file entitled "53022A_SeqListing.txt", 17,859 bytes, created at August 8, 2019. [0004] incorporated by reference [0005] The following applications are hereby incorporated by reference in their entirety: International Patent Application No. PCT / US 2012 / 049331, filed August 2, 2012, which claims U.S. Provisional Patent Application No. 61 / 515,191, filed August 4, 2011 U.S. Patent Application No. 11 / 410,540, filed April 25, 2006, which claims U.S. Provisional Patent Application No. 60 / 792,645, filed April 17, 2006, U.S....

AI Technical Summary

Problems solved by technology

However, highly concentrated protein formulations present several problems, including instability due to the formation of particulates and increased viscosity due to numerous intermolecular interactions due to the macromolecular nature of antibodies

Highly viscous formulations are also difficult to manufacture, difficult to draw into syringes and difficult to inject

Using force when handling viscous formulations can lead to excessive foaming, which can lead to denaturation and inactivation of active biologics

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