The COVID-19 novel coronavirus pandemic has highlighted the biopharmaceutical industry’s need to create and implement chemistry, manufacturing, and controls (CMC) strategies that can expedite drug development during times of crisis. This bold topic was the premise of the 2021 CASSS Well-Characterized Biotechnology Products (WCBP) forum titled “Special Edition: Creating CMC Strategies for Pandemics and Beyond.” Held virtually on 25–28 January and 1–4 February 2021, the eight-day event addressed manifold considerations for SARS-CoV-2 virus prevention, diagnosis, and treatment. Five hundred attendees representing 100 companies and academic organizations from across 15 nations grappled with how to manage the needs of the biopharmaceutical supply chain, repurpose existing drugs, apply prior knowledge, adapt traditional process development paradigms, leverage existing platform technologies, and accelerate technical transfers amid unprecedented requirements. In this eBook, WCBP leaders summarize key insights from the event’s presentations, panel discussions, and workshop groups. Read the eBook now to learn how CMC strategies for pandemics might shape — and perhaps accelerate — all future development activities for vaccines, conventional biologics, and protein-based diagnostics.

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