Frequently Asked Questions
Master Cell Banks/Working Cell Bank Manufacturing
In a traditional relationship with a CMO for cell banking, there are “hand-over” points to be considered, each of which can add time delays to your overall programme plan. With our integrated Cellca CLD and cell banking approach we can accelerate the programme in the following ways:
- RCB entry into the Cell Banking Facility requires sterility, identity and mycoplasma assurance. Testing of the RCB will run concurrently with the final stages of the CLD process saving approximately 4-8 weeks.
- As this cell banking process is specifically designed around the Cellca CLD platform, there is no requirement for pre-studies to be carried out and the cell banking can commence immediately on receipt of the RCB (and in line with clean room slot availability). This saves approximately 4 weeks.
- As an integrated biosafety testing organisation time delays for shipping and scheduling, the assays can be reduced by pre-allocation of testing slots.
- From the point of receipt of the RCB to release of the MCB, one can use the following estimated timeline:
|1. Cell banking process||3 weeks|
|2. Cell Bank Release Testing||6 weeks; limited to sterility, mycoplasma & ID testing|
|3. Cell Bank Characterization||12 weeks; runs concurrently with Release Testing|
|4. Quality Release of Bank||1 week|
|5. Overall timeline from RCB to Release||GMP Cell Banks can be released upon completion of sterility and mycoplasma testing. This could be completed within 9 weeks of initiation of the bank. Full characterisation of the bank to confirm freedom from other adventitious agents could be completed within 12 weeks|