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
Milestones | Content | Delivery standard |
---|---|---|
Analytical method transfer and validation | In process control and release test transfer and verification | / |
Cell line transfer and testing | MCB & WCB transfer Mycoplasma and sterility test |
/ |
Process transfer and validation | Cell culture & purification process transfer 3/10L engineering run |
The process and product meet the quality requirements |
Material purchasing and release test | Material purchasing Release test of raw materials per client's internal control standard Release test of excipient and packaging materials per pharmacopoeia or client's standards |
/ |
GMP documentation preparation for drug substance production | Prepare GMP Documentation including process instructtion, SOP, BPR and training records | Comply with relative requirements of GMP documentation system |
200L-scale GMP manufacturing of drug substance | 1 batch 200L-scale GMP manufacturing of drug substance | Production in compliance with GMP quality management regulation, sample passed all the required QC tests. |
Drug substance release test | Drug substance release test | Complete release test according to GMP requirement |
GMP documentation preparation for fill and finish | Prepare GMP Documentation including process instructtion, SOP, BPR and training records | Comply with relative requirements of GMP documentation system |
Fill and finish | 1 batch of fill and finish (vials) | Production compliance to GMP, and samples are meet quality requirements. |
Drug product release test | Drug product release test | Complete release test according to GMP requirement |
Milestones | Content | Delivery standard |
---|---|---|
Analytical method transfer and validation | In process control and release test transfer and verification | / |
Cell line transfer and testing | MCB & WCB transfer Mycoplasma and sterility test |
/ |
Process transfer and validation | Cell culture & purification process transfer 3/10L engineering run |
The process and product meet the quality requirements |
50L Qualification run | 1 batch of 50L qualification run | |
Material purchasing and release test | Material purchasing Release test of raw materials per client's internal control standard Release test of excipient and packaging materials per pharmacopoeia or client's standards |
/ |
GMP documentation preparation for drug substance production | Prepare GMP Documentation including process instructtion, SOP, BPR and training records | Comply with relative requirements of GMP documentation system |
500L-scale GMP manufacturing of drug substance | 1 batch 500L-scale GMP manufacturing of drug substance | Production in compliance with GMP quality management regulation, sample passed all the required QC tests. |
Drug substance release test | Drug substance release test | Complete release test according to GMP requirement |
GMP documentation preparation for fill and finish | Prepare GMP Documentation including process instructtion, SOP, BPR and training records | Comply with relative requirements of GMP documentation system |
Fill and finish | 1 batch of fill and finish (vials) | Production compliance to GMP, and samples are meet quality requirements. |
Drug product release test | Drug product release test | Complete release test according to GMP requirement |