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.

Read more


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).

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

Solutions for bioprocessing

From the small-scale bench to full commercial manufacturing, we enable our customers to reach the market with new treatments for patients, faster and safer. Learn more about our offering for biopharmaceutical manufacturing.

Customer support

Contact us

Ready to streamline your bioprocessing manufacturing workflows? Avantor Biopharma Production can help.

Avantor®, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve. Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world.