METHODS RELATED TO BIOLOGICS

摘要

The present invention relates to the characterization and production of biologics.

主权项

1. A method of manufacturing a recombinant antibody drug product, comprising:
providing or obtaining a test antibody preparation; determining (or acquiring a determination of) whether the level of antibody isoform A in the test antibody preparation is within a first pre-determined range, wherein antibody isoform A comprises a first amino acid sequence consisting of amino acids 1-214 of SEQ ID NO:1, a second amino acid sequence consisting of amino acids 1-448 of SEQ ID NO:2 and a third amino acid sequence consisting of amino acids 1-447 of SEQ ID NO:2 wherein amino acid 447 is a C-terminal Pro-NH2, and processing at least a portion of the test antibody preparation as an antibody drug product if the level of antibody isoform A is within the first predetermined range, thereby manufacturing an antibody drug product.