Cytovance® Biologics announced that it has received a notification letter and an Establishment Inspection Reports (EIRs) from the U.S. Food and Drug Administration (FDA) for its Oklahoma City site, FEI registration numbers: 3006341547. The notification and the EIR are to close, under 21 CFR 20.64(d)(3), a Pre-Approval Inspection (PAI) that occurred between May 1st and May 9th, 2019, for a client’s product. The client has filed its product with the FDA for market approval.
This was Cytovance’s second PAI. The previous PAI, associated with a recent FDA market approval, took place in April 2018.
This second PAI is a major milestone for Cytovance, further demonstrating its capabilities and cGMP compliance in manufacturing commercial products for clients. Eddie Miranda, Vice President of Quality at Cytovance Biologics, states, “I am very proud of the entire Cytovance team that accomplished this major success. Cytovance will continue to pursue the highest quality standard in its services to clients.”
“Compliance to cGMP is at the core of Cytovance’s business,” said Yan Wang, CEO of Cytovance Biologics, “Our clients demand it, and we are one hundred percent committed to it.”
About Cytovance Biologics
Cytovance® Biologics is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that excels in the rapid and cost-effective development and manufacture of large molecule active pharmaceutical ingredients (APIs) from both mammalian cell culture and microbial fermentation such as monoclonal antibodies, fragment antibodies, bispecifics, enzymes, fusion proteins, vaccines and other biological products including plasmid DNA and cell-based therapeutics. In addition to our clinical and commercial cGMP API manufacturing services, Cytovance offers well integrated development services supporting the entire product lifecycle including cell line development, cell banking, microbial strain development, process and analytical development, and process characterization. A centralized, responsive program management team coordinates all critical chemistry, manufacturing and controls (CMC) activities for each client program around raw materials management, QC testing, ICH stability studies, and regulatory support. Our 140,000 sq. ft. state-of-the-art facilities in Oklahoma City are designed to meet U.S., EU, and other global regulatory standards.