ANALYSIS OF DISULFIDE BONDS

摘要

The present disclosure relates to methods of evaluating, identifying, and/or producing (e.g., manufacturing) pharmaceutical products (e.g., protein therapeutics). In some instances, methods herein allow highly resolved evaluation of the disulfide bond profiles of protein therapeutics.

主权项

1. A method of manufacturing a pharmaceutical product, said method comprising:
obtaining a sample of a batch of a test biologic; determining a disulfide bond profile for said sample; acquiring an assessment made by comparing said determined disulfide bond profile with a disulfide bond profile of a target protein (e.g., a specification including a disulfide bond profile of a target protein), wherein said target protein is a biologic approved under a primary approval pathway; processing said batch of said test biologic into a pharmaceutical product if said assessment reveals said determined disulfide bond profile conforms with said disulfide bond profile of said target protein; thereby manufacturing a pharmaceutical product.