- Production of Pre-Master Cell Bank
- Simulation of MCB and WCB to determine GMP cell banking parameters
- Production of GMP MCB and WCB (200 vials of each)
- QC testing and QP release
- Storage of GMP Cell Banks
All cell banks are produced in controlled clean rooms using products of non-animal origin material and are certified animal-free.
The banks are manufactured in GMP accredited facilities under an accredited Quality Management System.
The GMP cell banks are manufactured in accordance to the requirements defined in ICH guideline Q5D and release by a Qualified Person (QP) in our FDA inspected facility.