Challenges in Biopharmaceutical Scale-up to Production
Challenges in the scale-up of biopharmaceuticals to production are described with a primary emphasis on antibody production using suspension-adapted animal cell lines grown in fed-batch bioreactors. Specific challenges focus on cell line development, media formulation, fed-batch process definition, and scale-up. Cost implications for biopharmaceutical production are examined for these specific areas of technology development. Decision and cost analysis methodologies, research and development expenditures, manufacturing process economics, upfront capital investment costs, ongoing expenditures, and efficiency initiatives are described as they relate to current and future production opportunities
About the Author
Beth Junker, Ph.D.
Senior Director, Fermentation Development and Operations, Merck Research Laboratories
Beth Junker received her BSE degree in chemical engineering (Princeton University, 1984) and her Ph.D. degree in biochemical engineering (Massachusetts Institute of Technology, 1989). For the past 15 years, she has been working in the fermentation development and operations area of the Bioprocess Research and Development Department of Merck Research Laboratories. Along with process development responsibilities for natural product-producing fermentations, Dr. Junker is responsible for developing scale-up techniques for suspension animal cell processes. She has led efforts to culture hybridoma and insect cells in modified-microbial and dual use fermenters, as well as demonstrate viral production for anchorage-dependent cells using both microcarriers and static mixer reactors.