The global pandemic outbreak COVID-19 (SARS-COV-2), has prompted many pharmaceutical companies to develop vaccines and therapeutic biologics for its prevention and treatment. Most of the therapeutic biologics are common human IgG antibodies, which were identified by next-generation sequencing (NGS) with the B cells from the convalescent patients. To fight against pandemic outbreaks like COVID-19, biologics development strategies need to be optimized to speed up the timeline. Since the advent of therapeutic biologics, strategies of transfection and cell line selection have been continuously improved for greater productivity and efficiency. NGS has also been implemented for accelerated cell bank testing. These recent advances enable us to rethink and reshape the chemistry, manufacturing, and controls (CMC) strategy in order to start supplying Good Manufacturing Practices (GMP) materials for clinical trials as soon as possible. We elucidated an accelerated CMC workflow for biologics, including using GMP-compliant pool materials for phase I clinical trials, selecting the final clone with product quality similar to that of phase I materials for late-stage development and commercial production.

中文翻译：

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重塑细胞系开发和 CMC 策略以快速应对大流行爆发

全球大流行爆发 COVID-19 (SARS-COV-2)，促使许多制药公司开发疫苗和治疗性生物制剂以预防和治疗。大多数治疗性生物制剂是常见的人类 IgG 抗体，这些抗体是通过下一代测序 (NGS) 与康复患者的 B 细胞鉴定的。为了对抗像 COVID-19 这样的大流行爆发，需要优化生物制剂开发策略以加快时间表。自从治疗性生物制剂出现以来，转染和细胞系选择的策略一直在不断改进，以提高生产力和效率。NGS 也已用于加速细胞库测试。这些最新进展使我们能够重新思考和重塑化学、制造、和控制 (CMC) 策略，以便尽快开始为临床试验提供良好生产规范 (GMP) 材料。我们阐明了生物制剂的加速 CMC 工作流程，包括使用符合 GMP 的池材料进行 I 期临床试验，选择产品质量与 I 期材料相似的最终克隆用于后期开发和商业生产。