METHODS FOR REDUCING PARTICLE FORMATION AND COMPOSITIONS MADE USING THEM

Claims

The biopharmaceutical compositions and drug products disclosed herein exhibit reduced levels of subvisible particle formation. These compositions and drug products comprise a protein and a surfactant or stabilizer containing a high percentage (e.g., at least 97%) of a long-chain fatty acid ester. Furthermore, methods for preparing and storing such compositions and drug products are disclosed herein.

1. A pharmaceutical product packaged in a primary packaging component, characterized in that the pharmaceutical product comprises: from 100 mg / mL to 250 mg / mL of an IgG antibody; and a mixture of polyoxyethylene sorbitan fatty acid esters, wherein an oleic acid ester content in the mixture is 98% to 100% of all fatty acid esters in the mixture.

13. A process for reducing the formation of subvisible and visible particles in a pharmaceutical product, characterized in that it comprises: a) preparing a pharmaceutical product; b) including a pharmaceutical composition comprising 100 mg / mL to 250 mg / mL of an IgG antibody, a mixture of polyoxyethylene sorbitan fatty acid esters, wherein the oleic acid ester content in the mixture is 98% to 100% of all fatty acid esters in the mixture, and an esterase; and c) storing the pharmaceutical product at a temperature between 2°C and 8°C for a period between 6 and 24 months, after which between 0 and 3,000 particles with a diameter between 10 microns and 300 microns can be detected in the pharmaceutical product by flow imaging microscopy or membrane microscopy.