Akadeum has been successfully customer-audited per US and EU GMP standards, and the products meet endotoxin, sterility, and viral requirements per USP and ICH standards. As expected for raw materials ...
Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S.
ANKTIVA ® Drug Substance completed and released with two-year storage stability data sufficient for 170,000 doses of ANKTIVA product ImmunityBio’s 400,000 square foot GMP fill-finish facility in ...