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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