Challenges in Chromatography
Processing times can be reduced and yields increased by utilizing new hydrophobic interaction chromatography tools
Advances in protein and peptide engineering continue, enabling the creation of new biological products with improved therapeutic and diagnostic potential. Bringing these promising biologics to market effectively depends, in part, on solving significant downstream purification process challenges – such as separation of closely related impurities – that are the result of the increased complexity of producing these biologics.
Platform-based chromatographic approaches have been successful in separating and purifying monoclonal antibody products, but the newer generations of biologics feature different hurdles for purification process developers to overcome. Product- and process-related impurities, including host cell protein, aggregates, and charge and glycosylation variants, are persistent and often difficult to separate. As a result, process developers are increasingly exploring mixed-mode and multimode chromatographic media to achieve these separations.
Author
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).
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