The development of biologics, from initial molecule selection to commercial product, presents
complex challenges related to stability, manufacturability, and immunogenicity. Skipping essential risk
assessments can lead to costly consequences, including reformulation, reduced shelf life, additional testing,
regulatory delays, or even project termination. Download this article to learn more about how a structured,
data-driven developability workflow can de-risk biologics during early stages of development.
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Bristol Myers Squibb's Nathan Pennell explains how the MRD endpoint supports accelerated approval in multiple myeloma without changing how clinicians monitor patients.