Oklahoma City, OK. – August 28, 2019 – Cytovance® Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, announced today the company will participate in the upcoming Bioprocess International (BPI) Conference #BPIconf at the Boston Convention and Exhibition Center (BCEC) in Boston, MA on September 9-12, 2019.
Oklahoma City, OK June 27, 2019. Cytovance® Biologics, a leading biopharmaceutical contract development and manufacturing organization (CDMO), announced today the appointment of Jesse McCool, Ph.D. as Chief Technology Officer. Dr. McCool will continue to provide scientific and operational oversight as the SVP of R&D Services and will be responsible for leading Cytovance’s overall technology transformation.
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.
Cytovance® Biologics announces Siwa Biotech’s receipt of FDA licensure of Anti-Fya and Anti-Fyb recombinant monoclonal Blood Grouping Reagents. These reagents were developed and manufactured by Siwa Biotech Corp. and filled by Cytovance®. In 2018, Cytovance® completed a successful Pre-Licensing Inspection (PLI) by the FDA in support of these products with no form 483 issued.
Cytovance® Biologics, Inc., a leading full-service biopharmaceutical contract development and manufacturing services company is pleased to announce the United States Food & Drug Administration (FDA) has concluded a successful Pre-License Inspection at Cytovance® with no 483 observations.
Cytovance® Biologics, Inc., a leading full-service biopharmaceutical contract manufacturer of mammalian and microbial biologics, announces completion of first batch in new state-of-the-art 1000L microbial facility.
Cytovance® Biologics, Inc., a leading full-service biopharmaceutical contract manufacturer of mammalian and microbial biologics, announces and welcomes Edwin Miranda as Vice President of Quality. Edwin Miranda will be leading the full breadth of Cytovance’s Quality function.