Investing in high quality, compliant cell banks to ensure consistent cell performance through the various stages of research, development and manufacturing. With the right cell bank strategy, you can have confidence your first manufacturing batch is comparable to your research experiments performed in previous years.
High quality master and working cell banks
The most robust strategy for large scale cell production is the use of a Master Cell Bank (MCB) and Working Cell Banks (WCB). An MCB is produced and extensively characterised, ensuring an acceptable quality of starting cells for future banks. WCB’s are then produced from these MCB vials, with each WCB typically using comparable manufacturing processes to ensure consistency. This strategy can yield tens of thousands of vials for research, development and manufacturing, enough vials to support production of some cellular agriculture products for decades, and all from a single starting vial.
Our quality management system is built to support effective operational control and the required documentation to support regulatory submissions for your cell banks.
Achieving quality and consistency
Consistent quality cell banks are needed for both research and manufacturing. Our semi-automated cell banking process reduces variability across each vial in the cell banks we produce. Our experience with large-scale cultures supports the generation of large numbers of vials per bank with higher numbers of cells per vial.
- Scale – Our scale-up experience with both adherent and suspension cultures allows us to produce large quantities of cells needed for large cell bank sizes.
- Speed – We use semi-automated cell banking processes to reduce the time taken between harvesting and cryopreservation of cells.
- Consistency – our semi-automated process lets us fill up to 200 vials in less than 5 minutes, maximising consistency between the first and last vial.
- Control – we use controlled rate freezers to monitor the cryopreservation process. Once in storage, our cell bank storage tanks are monitored, to give you and the regulators confidence in each vial.
If you are unsure which process or cryoprotectant is right for your cells, we can conduct studies to evaluate a range of:
- Cell concentrations
- Vial types, sizes and fill volumes
- Freezing profiles
Characterising cell banks
From each bank, quality and consistency can be tested before any further studies are performed. Assessing sterility, recovery, growth, differentiation and identity are all important characteristics. This additional characterisation effort typically goes into the Master Cell Bank, to ensure long-term suitability for subsequent working cell banks. Comparability between working cell banks is also important, to ensure acceptable performance when replacing depleted banks.
Our experience and capabilities
- Size of vials – 1mL, 2mL, 5mL
- Number of vials – up to 200 per bank
- Vial formats – vials, bags
- Storage in liquid Nitrogen (vapour phase)
Other custom vial sizes and numbers of vials per bank sizes are available on request