A common question of our clients is related to the size of a cell bank that is needed for future commercial manufacturing. How many vials of Master Cell Banks (MCB) and Working Cell Banks (WCB) do I need? Is this number sufficient for later production needs?
Mammalian cell lines including Vero cells are generally amenable to cryopreservation, and this makes it possible to prepare reliable cell banks of homogenous aliquots that can be stored in a stable state at ultra-low temperature.
For cell banking, a two-tiered system based on a Master Cell Bank and a Working Cell Bank is the industry standard. Ampoules from the Master Cell Bank are used to produce larger Working Cell Banks that can be used for manufacturing purposes. If prepared correctly, the Master/Working Cell Banks system can provide reproducible and reliable supplies of identical cultures over many decades. MCB vials are identical and are produced from a single cell culture batch. Nuvonis is providing 100 MCB vials to its clients allowing for production of very large quantities of WCB vials. Out of one MCB vial, 500 – 1,000 vials of WCB cells can be produced easily (Fig.).
Therefore, using a two-tiered Master Cell Bank and Working Cell Bank system up to 100,000 WCB ampoules of identical quality and passage number (“age” of Vero cells) can be produced. The WCB ampoule demand of a very large vaccine manufacturing plant is estimated to be 100 – 200 ampoules per year. Thus, a two-tiered cell bank system in theory supports production for more than 600 years.
By using the two-tiered Master Cell Bank and Working Cell Bank system of Nuvonis Vero cell banks, our customers can be sure that all their future WCB production needs are covered, and quality/regulatory requirements are fulfilled.