OKLAHOMA CITY, May 09, 2018 (GLOBE NEWSWIRE) -- 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.
The focus of the five-day PLI was quality systems, facilities, maintenance programs and the manufacturing of client’s candidate product.
“We are very pleased with the result of the FDA inspection demonstrating Cytovance’s unwavering commitment to quality and patient safety,” stated Eddie Miranda, Vice President of Quality at Cytovance Biologics. “I am proud of the entire Cytovance team who achieved such a success. This major milestone paved the way for Cytovance Biologics to enter commercial manufacturing of biopharmaceuticals beyond clinical production. Cytovance remains committed to providing the highest quality and long-term services to its clients.”
About Cytovance Biologics, Inc.
Cytovance® Biologics is a biopharmaceutical contract manufacturing company specializing in the production of therapeutic proteins and antibodies from both mammalian cell culture and microbial fermentation. In addition to its cGMP manufacturing services, the company offers process development, cGMP cell banking and support services from its Oklahoma City state-of-the-art facilities.