GMP Manufacturing
Accelerating GMP manufacturing while pursuing excellence
State-of-the-art 6,400 sq ft MHRA-inspected and licensed GMP facility located in central London
GMP vector products offered: LV and gamma-retro
Adherent and suspension cell lines available, initially delivering between 12L and 50L scale
Qualified internal & external QC testing vendors to deliver < 14-week turnaround times
Two full-time QPs compress wait times to QP certification and release of your vector, with a target of 6 months from the start of your campaign
Master Batch Records informed by the prior experience of ~200 GMP batches
Close collaboration with Process Development and Innovation teams
Single-use closed system harvest and downstream purification
Experienced regulatory submission writers for MHRA, FDA and EMA filings
Technology transfer and support for commercial scale manufacture