A Quality Design Approach For Antibody Production
Abstract: Culture media optimization is an inevitable part of upstream process development that is geared to reduce the heterogeneity of numerous different charge variants and modifications during the production of therapeutic monoclonal antibodies (mAbs). A quality by design (QbD) approach is utilized during expression, especially with media optimization to significantly minimize changes in the glycosylation pattern, charge variants, aggregates, and low-molecular-weight species. QbD approach defines and assures the quality of the product through various development stages. An important step in QbD is the determination of the main quality attributes.
- 1) The relationship between the culture media components and the main quality attributes could be successfully utilized for rational optimization of mammalian cell culture media for mAbs production.2) Optimization of cell culture media and conditions based on the Stability Fingerprinting®
3) Different approaches minimize the heterogeneity of antibodies during their expression. Specially modulating cell culture conditions like media, pH, temperature, dissolved oxygen (dO2) as well as mutations of primary sequence reduces the rate of post-translations modifications on expressed proteins/antibodies.
Originally Presented Live By:
Indu Javeri is the President of CuriRx and former CEO of Formatech, Head of Manufacturing and Development Abbott Biotech, Associate Director Cambridge NeuroScience.