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OKLAHOMA CITY, March 08, 2021 (GLOBE NEWSWIRE) — Cytovance® Biologics, a leading biopharmaceutical contract development and manufacturing organization (CDMO) of mammalian, microbial biologics and gene therapy plasmid DNA (pDNA), announces a licensing opportunity for pDNA manufacturing. The Keystone Expression System® pDNA platform is an end-to-end solution for manufacturing GMP pDNA at scale in a manufacturer’s own facility.
“This is a great opportunity for biologics manufacturers to reduce the time and cost of getting their pDNA products to market through the use of our perfected manufacturing process,” stated Matt Delaney, Vice President of Business Development and Marketing for Cytovance. “Our platform is uniquely designed to process plasmids with low shear lysis and purification steps to produce high-quality, high-yield pDNA,” Mr. Delaney added.
License opportunities are currently available for either a 30L or 300L manufacturing scale. Each license includes end-to-end documentation including process descriptions, analytical standard operating procedures, critical equipment lists, facility layout, and much more. To ensure that pDNA manufacturing can begin quickly, Cytovance also offers hands-on process training, with our experts, at the manufacturer’s facility.
To learn more about Cytovance Biologics and the opportunity for pDNA Manufacturing Licensing, visit https://www.cytovance.com/about-us.
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 its 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.
Media Contact:
Jodie Gutkowski
Tel: 405-319-8309
E-mail: jgutkowski@cytovance.com
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