Cell Culture Platform Technologies in Speed-Up CMC Process
Posted on March 7, 2023
H. Fai Poon, President, Jun Yuan, CTO, Wayne Wenyan Xu, Vice President of Research and Development, Henry Xiaoyu Yu, Director of Research and Development, Lothar Yulin Jiang, Director of Manufacturing, Quacell Biotechnology Ltd, Zhongshan, Guangdong, China
Abstract The commercial success of monoclonal antibodies has made biologics attractive to pharmaceutical companies. The approval pathway is often required to extensive chemistry, manufacturing and control (CMC) study to ensure the long-term safety and efficacy of biologics. However, the CMC studies ...
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