Tianjin’s Practice of Boosting CGT Products Incubation through GMP Pilot-Scale Platforms of New R&D Institutions
YUAN Hui1,2, ZHANG Honghai1,2, CHEN Jisheng1,2, SI Yuan1,2, WU Shuang1,2, LI Shanshan1,2, CHENG Tao1,3, ZHANG Yingchi1,2,3*
Pilot-scale trials represent a crucial stage in translating scientific research achievements from the laboratory to large-scale production, serving as a key bridge to cross the “valley of death” in the commercialization of R&D outcomes. Cell-based products, as living pharmaceuticals, involve complex manufacturing processes and pose significant challenges in quality control. With the rapid advancement of the cell and gene therapy industry, traditional small-scale laboratory preparations can no longer meet the demands of clinical translation and industrialization. Therefore, the construction of a pilot-scale platform that meets the requirements of GMP (good manufacturing practice) for pharmaceuticals has become imperative. Taking the GMP pilot-scale platform of Haihe Laboratory of Cell Ecosystem as an example, this paper systematically summarizes its effective practices in hardware construction, GMP, and scientific research programs. This study is intended to provide reference and insights for similar projects.
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