Nuvonis Vero Cell Banks (R&D and GMP)
Vero cells have been used for producing viral vaccines for humans ever since microcarrier- based cell culture processes were developed in the 1970s. WHO has recommended the use of well characterized cell substrates back in 1998 (WHO Technical Report Series 878; Expert Committee on Biological Standardization). Due to its stability and well-documented performance regarding the quality and quantity of viral yield, Vero cells are widely accepted by Regulatory Authorities incl. FDA and used for commercial vaccine production.
Vero cells have been approved for Polio, Smallpox, Rabies, Japanese Encephalitis, rotavirus, Vaccinia and Inﬂuenza vaccines and are used for the development of new vaccines and vaccine vectors, such as Vaccinia, Polio, Ross River, West Nile, Chikungunya, tick-borne encephalitis virus (TBE), Hepatitis A, SARS-Coronavirus etc.…
Nuvonis cell banks are state- of-the-art, as they were generated under serum free and animal component free conditions and grow in medium that is commercially available.
By using Nuvonis GMP Vero cell banks, you can avoid cumbersome and time-intensive production of your own cell bank and eliminate associated risks and costs. Thus, you can immediately start with GMP production of your product on a fully tested cell substrate.
State-of-the-art serum/animal component free Vero cells from research to market scale
- MCB and WCB cells are produced under serum and animal-free media conditions. Cells are passaged using animal-free enzyme formulations
- The use of a two-tiered cell banking system allows unlimited production of both MCB and WCB vials
- Proven non-tumorigenicity at EOP passage level 160 allows flexibility in terms of process scale-up
- Nuvonis’ GMP MCB and WCB cell banks can be licensed at attractive terms
What you get
- Fast and easy access to a R&D working bank vial to evaluate virus growth on Nuvonis Vero Cells including protocols and technical support.
- Access to a GMP-Working Cell Bank passage 145
- Access to a GMP-Master Cell Bank passage 141
- Full documentation and testing results (available on a data site)
- A passage 160 Non-Tumorigenicity report
- The size of the cell banks allows covering all production needs, from clinical trial material to very large market scale productio
Nuvonis‘ Vero Cell Banks have been tested according to national and international guidelines (US FDA cGMP – 21 Code of Federal Regulations, European Pharmacopoeia and ICH guidelines), e.g.,
- In vivo Adventitious Virus Assay: Detection of Inapparent Viruses by Inoculation of a Test Article into Guinea Pigs, Mice (adult and suckling) and Embryonated Chicken Eggs
- Tissue Culture Safety Testing – MRC-5, Vero and Primary AGMK (28-day duration)
- Testing for Mycoplasma According to the European Pharmacopoeia
- Testing for the Presence of Agar Cultivable and Non-Cultivable Mycoplasma
- Isoenzyme Analysis of Cell Cultures by Agarose Gel
- Sterility Testing of Final Containers and Biological Products (Direct Method)
- Bacteriostasis and Fungistasis Final Product (Direct Method)
- Tumorigenicity at passage 160 (End of Production Cells)
- 16 Week Tumorigenicity Assay in Adult Nude Mice (GLP)
Documentation of all tests performed, and test results are available at a data site.