时间轴
2019年冠状病毒病(COVID-19)
大流行
药物开发
严重急性呼吸综合征冠状病毒2型(SARS-CoV-2)
新产品开发
计算机科学
医学
业务
疾病
传染病(医学专业)
药理学
内科学
药品
数学
统计
营销
作者
Kee W. Tan,Pengfei Ji,Zichen Qian,Ge‐Xia Qiao,Shuai Wang,Qin Li,Mingzhu Gu,Qi Zhang,Chengjian Hou,Yang Huang,Dujuan Lian,Junghao Wang,Zheng Zhang,Sam Zhang,J. Wu,Weichang Zhou
摘要
Since the Coronavirus Disease 2019 (COVID-19) outbreak, unconventional cell line development (CLD) strategies have been taken to enable development of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-neutralizing antibodies at expedited speed. We previously reported a novel chemistry, manufacturing, and control (CMC) workflow and demonstrated a much-shortened timeline of 3-6 months from DNA to investigational new drug (IND) application. Hereafter, we have incorporated this CMC strategy for many SARS-CoV-2-neutralizing antibody programs at WuXi Biologics. In this paper, we summarize the accelerated development of a total of seven antibody programs, some of which have received emergency use authorization approval in less than 2 years. Stable pools generated under good manufacturing practice (GMP) conditions consistently exhibited similar productivity and product quality at different scales and batches, enabling rapid initiation of phase I clinical trials. Clones with comparable product quality as parental pools were subsequently screened and selected for late-stage development and manufacturing. Moreover, a preliminary stability study plan was devised to greatly reduce the time required for final clone determination and next-generation sequencing-based viral testing was implemented to support rapid conditional release of the master cell bank for GMP production. The successful execution of these COVID-19 programs relies on our robust, fit for purpose, and continuously improving CLD platform. The speed achieved for pandemic-related biologics development may innovate typical biologics development timelines and become a new standard in the industry.
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