Cytovance® Biologics Introduces an Integrated Single-use Platform for Plasmid DNA (pDNA) Manufacture
OKLAHOMA CITY, Oct. 21, 2019 (GLOBE NEWSWIRE) -- Cytovance Biologics is a leading biopharmaceutical CDMO with a 15-year track record of supplying drug substance to clients, offering fast and cost-effective development of protein biologics from pre-clinical to commercial supply, globally. Cytovance Biologics announced today the addition of an integrated single-use platform for the manufacturing of plasmid DNA (pDNA) at their facilities in Oklahoma City, OK. Two grades are available (Critical Reagent Grade™, CGMP-grade) in lot sizes from 1g to 50g. One grade is available (R&D-grade) in lot sizes from 1g to 5g.
With the increasing market growth and demand for pDNA, specifically the gene therapy market, Cytovance Biologics’ addition of this integrated platform will enhance its overall offering of capabilities and will better serve its current clients as well as future clients.
“Cytovance Biologics is committed in investing additional capabilities and infrastructure to serve our clients and enable them to improve the lives of patients all around the world,” commented Yan Wang, Chief Executive Officer of Cytovance Biologics. “With this new platform, our teams will ensure high-quality, fast, and affordable plasmid development and delivery, which will be key to our clients and ultimately benefit the patients.”
“With our years of experience with products of varying biological sources and complexities coupled with the principles of phase-appropriate CGMPs, Cytovance Biologics is uniquely positioned to offer clients the flexible options that are being sought in a robust gene therapy supply chain partner,” added Jesse McCool, Chief Technology Officer of Cytovance Biologics. “Whether our clients need pDNA for early pre-clinical work or for advanced commercial efforts, our team will ensure a cost-effective and robust supply of high-quality plasmids that align with the regulatory expectations across a product’s lifecycle.”
For more information on our integrated pDNA platform, please visit: www.cytovance.com/manufacturing/pDNA
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.
Cytovance® offers deep industry expertise and unique customized services for the scale-up and CGMP manufacture of protein-based therapeutics; from early-stage pre-clinical development to commercial production, for both mammalian and microbial. Further information can be found at www.cytovance.com
Cytovance® Biologics Media Contact Information Mr. Lonnie Barish, MBA VP, Business Development and Marketing Email: email@example.com Office: +1 405-319-8310