Quality
Vero and Avian Cell Banks were Produced under cGMP
Nuvonis Vero and avian cell banks have been produced under cGMP at our contract manufacturers. The manufacturers were qualified in advance, and several quality audits were performed, confirming highest standards in GMP manufacturing for our cell banks.
Vero and Avian Cell Banks are Fully Tested
Our Working and Master Cell Banks and the EPCB Bank have been tested according to international standards that are relevant both for manufacturing in Europe and the USA and are applicable in the rest of the world. Specifically, tests were performed according to lCH and WHO guidelines.
Vero and Avian Cell Banks Were Generated by a Team of Manufacturing Experts
Our key employees were involved in the clinical and commercial production of several different cell culture-based vaccines from small scale to 6,000L bioreactor scale. These vaccines were produced by several companies such as Baxter, BlueSky Immunotherapies, Vivaldi Biosciences and several non-disclosed customers and were used for clinical trials and for market supply. Therefore, we have specific experience and know-how on all practical issues of vaccine production, cell bank generation, use thereof, regulatory aspects and requirements for market scale production.
What Quality Means for Us
Quality Is a Key Requirement
Extensive testing of MCB, WCB and EPCB cells confirm the high-quality level of Nuvonis’ Vero cells. As we did not introduce animal components, such as, animal derived enzymes or serum in the generation of both Master and Working Cell Banks, several common issues involving complicated testing (prion-free etc.) is not relevant. Nuvonis MCB and WCB Cell Banks meet HALAL standards.
Focus on the Quality of Your Product…
… and leave the quality of the cell substrate to us. We believe that our customers should focus on development and production of their medicinal product. Nuvonis has many years of expertise in cell culture substrates for virus production with quality systems in place that allow the continuous improvement of our MCB and WCB products. Supplying you with Master and Working Cell Banks - let us take care of that part of your development.
Check Our Quality!
All data about the Vero and avian cell banks including origin, passage levels, testing results etc. can be viewed (but not downloaded) on a data site for interested partners. The only requirement is that interested parties sign a standard CDA.