Protein Characterization Through the Stages - Biomanufacturers should follow a risk-based approach to decide which methods to use to characterize their products. - BioPharm International


Protein Characterization Through the Stages
Biomanufacturers should follow a risk-based approach to decide which methods to use to characterize their products.

BioPharm International Supplements


As the biopharmaceutical industry continues to evolve, so must its analytical techniques. Protein characterization plays a critical role in determining the safety and efficacy of biological products, and as such there is a need to continue to improve the accuracy, sensitivity, specificity, and robustness of protein assays, and to develop novel assays that target specific areas of concern. Biomanufacturers must leverage their experience and knowledge to determine which methods to apply at each stage of the drug development process, and use a risk-based approach to guide their selection. Collaboration between manufacturers and regulatory agencies is critical in the ongoing search for an answer to the question—How well characterized is well characterized enough?

Lisa Crossley, PhD, the founder and principal of BioVentures, Ontario, Canada, 888.405.9549,


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