2019年冠状病毒病(COVID-19)
2019-20冠状病毒爆发
严重急性呼吸综合征冠状病毒2型(SARS-CoV-2)
病毒学
倍他科诺病毒
医学
爆发
内科学
传染病(医学专业)
疾病
作者
Kee W. Tan,Pengfei Ji,Hang Zhou,Sam Zhang,Weichang Zhou
摘要
Abstract The COVID-19 pandemic has spurred adoption of revolutionary initiatives by regulatory agencies and pharmaceutical industry worldwide to deliver therapeutic COVID-19 antibodies to patients at unprecedented speed. Among these, timeline of Chemistry, Manufacturing, and Control (CMC), which involves process development and manufacturing activities critical for the assurance of product quality and consistency before first-in-human clinical trials, was greatly reduced from typically 12-15 months (using clonal materials) to approximately 3 months (using non-clonal materials) in multiple cases. In this perspective, we briefly review the acceleration approaches published for therapeutic COVID-19 antibodies and subsequently discuss the applicability of these approaches to achieve investigational new drug (IND) timelines of ≤10 months in over 60 COVID-19 and non-COVID-19 programs performed at WuXi Biologics. We are of the view that, with demonstrated product quality and consistency, innovative approaches used for COVID-19 can be widely applied in all disease areas for greater speed to clinic.
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