Cytovance® Biologics LLC, a biopharmaceutical contract manufacturing company specializing in mammalian cell culture, today announced the completion of a collaboration with Invitrogen´s PD–Direct® Bioprocess Services. Cytovance Biologics has successfully completed the process transfer and scale–up to 100 L of a fed–batch bioreactor production process using Invitrogen´s new CD OptiCHO TM Medium and CHO CD EfficientFeed TM supplement designed specifically for the fed–batch production process.
"We are very pleased with the results of the scale–up at Cytovance, which demonstrates the robustness of the integrated GIBCO® media product platforms across processing scales and the flawless transfer to the Cytovance team," Steve Gorfien, Director, BioProduction Products and PD–Direct® Services.
"The completion of this development collaboration models the scientific competence we apply to all of our projects," said John Lightholder, Vice President of Process Science of Cytovance Biologics.
The project with Invitrogen was executed in Cytovance´s multi–product cGMP production facility in Oklahoma City. The 44,000 sq. ft. facility meets the latest international regulatory standards and is custom–designed for efficient and cost–effective production. Cytovance specializes in the execution of clinical and commercial production of antibody and recombinant protein products derived from cell culture at scales up to 500L (w/v) from both fed–batch and perfusion processes. This project involved a 2–step scale–up from a shake flask process through two 5 L bioreactor runs and then into production in the Cytovance cGMP 100Liter production facility using a recombinant CHO cell line producing approximately 1 gram per liter.
About Cytovance Biologics
Cytovance Biologics is a biopharmaceutical contract manufacturing company specializing in the production of therapeutic proteins and antibodies from mammalian cell culture. In addition to its cGMP manufacturing services, the company offers process development, cGMP cell banking and support services from its Oklahoma City, Okla. facilities. The company´s approach couples considerable client–side experience with the necessary technical and operational expertise to deliver precision science, agile manufacture, and reasonable business to that meet international regulatory standards and facilitate efficient completion of clinical development. For more information on Cytovance, visit www.cytovance.com.
About Invitrogen´s PD–Direct® Bioprocess Services
PD–Direct® Bioprocess Services (www.invitrogen.com/pddirect) is a business unit within Invitrogen which specializes in developing cell lines, cell culture media strategies and process optimization leveraging Invitrogen products and capabilities for customers to shorten their development timelines and improve process performance. GIBCO® Bioproduction (www.invitrogen.com/bioproduction) is committed to the cell culture success of customers with products spanning their workflow from cell line development through to large scale bioreactor manufacturing.
Please visit Cytovance Biologics and Invitrogen PD–Direct® Bioprocess Services during the upcoming Bioprocess International Conference from September 23rd through the 26th at the Disneyland® Hotel Anaheim, CA.
