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
Lisa Crossley, PhD, the founder and principal of BioVentures, Ontario, Canada, 888.405.9549, firstname.lastname@example.org
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