Dr. Jessica Molek
Scientific Manager, Downstream Process Development, BioPharm R&D, Glaxo Smith Kline

October 7, 2015
11:00 am – 12:00 pm
C-121

“Industrial production of a monoclonal antibody: Perspectives from biopharmaceutical process development”

Abstract: Monoclonal antibodies (MAbs) are an important and growing class of therapeutic proteins. The production of these molecules is no longer limited to specialized start-ups but is embraced by the pharmaceutical industry as a standard tool within the arsenal to fight cancer, resist autoimmune diseases and treat other specific illnesses. MAb process development and production methods play a major role in the industry’s ability to effectively bring products to the market rapidly and economically after a target has been identified. This lecture will provide an overview of the key elements of MAb production, including: genetically engineering cell lines to produce high levels of MAbs; designing nutritional media and optimizing bioreactor conditions that promote maximum cell growth and MAb production; scaling up bioreactor processes to pilot-scale and manufacturing-scale facilities; designing purification processes that maximize product yield while maintaining product quality; and using bio-analytical methods to characterize key product attributes.