An Approach to Generating Better Biosimilars: Considerations in Controlling Glycosylation Variability in Protein Therapeutics
Continued expansion of the biosimilar marketplace has led to many commercial opportunities and technical challenges. The biological systems used to manufacture such drug products are inherently variable—a feature that has important consequences for the reproducibility, safety, and efficacy of the resulting products. A prerequisite for introducing such biologics into routine clinical use is to ensure consistency of lot quality. Process understanding and consistency are critical because slight changes can lead to adverse effects such as immunogenicity, with potentially serious safety implications.
In generating biosimilars, it is crucial to ensure that all clinically active attributes of the biotherapeutic, including protein posttranslational modifications (PTMs), are accounted for and confirmed. One such PTM that must be carefully monitored is protein glycosylation, which is the attachment of carbohydrates to a protein structure. Protein glycosylation can be a critical quality attribute for proteins used in discovery and biotherapeutics because it often plays a key role in their efficacy, safety, stability, and functionality.
Authors
Dr. Nandu Deorkar
Ph.D., MBA, Senior Vice President, Research & Development – Biopharma Production, Avantor
Nandu Deorkar is Senior Vice President, Biopharma Production Research & Development for Avantor. He is responsible for innovation strategy and planning, and execution of new products and technology development. During his more than 25-year career in research & development, Dr. Deorkar has been leading teams working on various aspects of upstream and downstream bioprocessing, single use systems, chemical/polymer R&D, drug development, formulation, drug delivery technologies, process development, and technology transfer. He has published more than 30 articles and holds more than 20 patents. Dr. Deorkar received Ph.D. from Indian Institute of Technology, Mumbai, India and MBA in Marketing from Fairleigh Dickinson University, Madison, NJ, USA.
Dr. Jonathan Fura
Manager, Research & Development
In his current role, Jonathan focuses on developing technologies that are utilized to advance the development and manufacturing of antibody-based biopharmaceuticals and diagnostics. Jonathan holds a Ph.D. in chemistry with a focus on developing immunomodulation therapeutic strategies.
Lori Fortin
Senior Manager, R&D
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