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.

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Authors

Dr. Nandu Deorkar

Vice President, Research & Development – Biopharma Production

During his more than 25-year career in materials technology research & development, Dr Deorkar has worked on various aspects of chemical/polymer R&D, drug development, formulation, drug delivery technologies, process development, and technology transfer. Dr Deorkar earned his PhD in chemistry from the Indian Institute of Technology, Bombay, and his MBA from Fairleigh Dickinson University, New Jersey (USA).

Jonathan Fura

Manager, Research & Development

In his current role, Jonathan focuses on developing technologies that are utilised 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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