Monday, July 30, 2007
P12

Rapid Development of Mammalian Cell Production Process of Clinical Material for Proof of Principle of Novel Therapeutic Molecules

Jianwei Zhu1, Yueqing Xie1, Vinay V. Vyas1, Beverly Keseling1, John Roach1, George Mitra1, and Stephen P. Creekmore2. (1) Biopharmaceutical Development Program, SAIC Frederick and National cancer Institute at Frederick, Building 432, Room208, Wood Street,, P O Box B, Frederick, MD 21702, (2) Biological Resources Branch, National Cancer Institute, Building 1052, PO Box B, Frederick, MD 21702

The Biopharmaceutical Development Program (BDP) of the National Cancer Institute at Frederick and SAIC Frederick manufactures biopharmaceuticals, including monoclonal antibodies, recombinant therapeutic proteins, and other biologics through mammalian cell culture. The BDP produces “research grade” as well as “clinical grade” materials for the purpose of exploring “proof of principle” of novel therapeutic concepts and early clinical trials. Our goal is the rapid translation of innovative scientific discoveries into therapeutic products that hold the real hope for preventing and curing cancer, AIDS, and other diseases. In the presentation, we elucidate the procedure that leads to successful development of a variety of therapeutic biologics through case studies, as well as expose development challenges in bringing projects from laboratory bench to clinic. A rapid cell culture process development procedure has been established in the program for biologics production using cell culture technology. A few projects will be analyzed in detail through cell line development, medium study, process development and scale-up, and technology transfer to GMP production.

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