Characterization and Release of Raw Materials Used in Upstream Processes for Production of Monoclonal Antibodies by Mammalian Cell Culture

by Uma Balasubramanian, Peter Salmon, David Robinson, and Jinyou Zhang, PhD
Volume 5, Issue 2 (Summer 2006)

Since the mid-1970’s, when Kohler and Milstein first discovered the process by which myeloma cells and splenocytes could be fused to produce monoclonal antibodies (MAbs), a whole new world of important therapeutic, prophylactic and diagnostic products has opened up, bringing in huge benefits for patients and manufacturers. The total sales of therapeutic MAbs reached more than $13 billion in 2005. Sixteen of the 18 FDA-approved MAbs came to the market after 1997, and over 150 are currently in clinical development, suggesting their increasing medical importance and the remarkable, recent advancements in development technology…

Citation:
Balasubramanian U, Salmon P, Robinson D, Zhang J. Characterization and Release of Raw Materials Used in Upstream Processes for Production of Monoclonal Antibodies by Mammalian Cell Culture. BioProcess J, 2006; 5(2): 7-13. https://doi.org/10.12665/J52.Balasubramanian