Articles
RSSA Strategy For Developing A Monoclonal Antibody Purification Platform
November 13, 2009
•Feature Article: A Strategy For Developing A Monoclonal Antibody Purification Platform
Anna Grönberg, Elin Monié, Maria Murby, Gustav Rodrigo, Elisabeth Wallby, and Hans J. Johansson
Monoclonal antibodies (MAbs), the fastest growing segment within the biopharmaceutical industry, currently represent about 25% of the field (1). More than 20 monoclonal antibodies and Fc fusion protein pharmaceuticals are approved for sale in the United States and Europe, and approximately 200 MAbs are in clinical trials for a wide variety of indications. The market is predicted to continue to grow by 20.9% per year and reach US$16.7 billion in 2008.
The vast need for MAbs for preclinical and clinical studies justifies standardizing the production process, from cell culture to downstream purification, as well as related analytical tools. Platform technologies are standard sets of unit operations, conditions, and methods applied to molecules of a given class. They are used by many large biopharmaceutical companies and allow for rapid and economical product development from R&D through clinical phases to manufacturing.
Click Here To Download:•Feature Article: A Strategy For Developing A Monoclonal Antibody Purification Platform
