The Cell Therapy Pilot-scale Process Technology Platform, based on the digital twin flexible cell intelligent manufacturing TjiaoLoong series production lines, offers customers services including method validation, quality research, stability studies, and the production of clinical phase I and II samples.
We employ stepwise scaling, empirical scaling, and mathematical simulation scaling methods to analyze and adjust aspects such as materials, equipment, and process parameters in the small-scale process.
In pilot process research, we investigate and optimize Critical Process Parameters (CPPs) to obtain a stable process that closely aligns with commercial production requirements. This platform provides representative cell samples for safety evaluation, quality research, and stability studies of cell-based new drugs.
