即使在“正常”的时候,公司需要平衡time to filing an investigational new drug (IND) application against careful consideration of processes that can have far-reaching consequences on the quality of biologic products. But supply-chain interruptions still feature prominently in the news during the ongoing COVID-19 pandemic. From equipment to chemicals to plastic components, end users, their suppliers, and (critically) their suppliers’ suppliers all are feeling growing uncertainty about production timelines and availability of materials. In this eBook, BPI’s editor in chief shares insights from her discussions with several biopharmaceutical industry consultants and suppliers about strategies for navigating pandemic conditions that are compounding the complexities of speed to IND.
The contributors offer practical advice for biologic developers to bridge current supply issues — and point to opportunities that are emerging during this precarious time, especially for some small bioprocess suppliers. The discussions contained herein show that no easy supply-chain solutions exist, and each company faces its own obstacles on the path to IND submission based on its size, experience, and capabilities. However, many traditional strategies for speed to IND remain relevant despite supply-chain constraints and shortages of raw materials. Read the eBook now to learn what strategies still apply and how the current pandemic compels investigation of alternative raw materials and suppliers for preclinical and early clinical bioprocesses.
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