Comprehensive and refined technology transfer process
Zero-Crossover with Unidirectional Flow
GenScript ProBio owns three segregated large-scale cell culture GMP upstream production lines, with a total culture volume of 2,200L (including 6x200L and 2x500L of disposable bioreactor systems); Two segregated downstream purification production lines.
GenScript ProBio GMP factory has strict physical isolation rules so that multiple samples can be produced simultaneously. The whole process, including solution preparation, cell culture, downstream chromatography and filtration, adopts single-use technology that effectively avoids the risk of cross-contamination. In addition, the GenScript ProBio Technology Transfer Team has established a comprehensive and refined technology transfer process and has implemented comprehensive risk control in the technology transfer process, which ensures the smooth transfer of customer projects and the successful completion of landing production.
Figure1. PDA TR65 Tech Transfer