How are your GMP products packaged, to be sure they are stable and sterile?
This question is part of the following Ask The Expert session:
GMP Proteins for Cell Therapy Manufacturing
Job Title: Product Manager
Unless requested differently, our GMP proteins are lyophilized in glass vials, which is typically very stable. We have environmentally controlled stability chambers that are in continuous use to ensure that there is a documented understanding of protein stability during storage. Although GMP proteins as not labeled as sterile, microbial testing is done on all bulk product and on each bottled lot of GMP proteins. In addition endotoxin testing is performed. Lot specific sterility testing as per USP or Ph. Eur. can be done upon request.