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 including the 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 they grow in a 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.
Working Cell Bank
A Vero R&D Working Cell Bank is available after concluding a simple Material Transfer Agreement (MTA) to evaluate virus growth of your vaccine/vector/product. Protocols for cell cultivation, thawing and general technical support are provided.
GMP Working Cell Bank
A Vero GMP Working Cell Bank is available to immediately start manufacturing clinical trial material at your GMP manufacturer.
GMP Master Cell Bank
The corresponding Vero GMP Master Cell Bank is available and can be transferred to a customer or a GMP manufacturer to allow unlimited manufacturing and complete manufacturing independence.
Nuvonis GMP Vero cells are available from storage facilities in Austria, France, the Netherlands, and the USA. Get GMP-grade and ready-to-use Vero cell banks for your production needs within days.
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 up to 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 an R&D working bank vial to evaluate virus growth of Nuvonis Vero cell banks including protocols and technical support.
- Access to a GMP-Working Cell Bank passage 145.
- Access to a GMP-Master Cell Bank passage 141.
- Access to full documentation and QC testing results (available at a data site).
- The size of the Vero cell banks allows covering all production needs, from clinical trial material to (very) large market-scale production.
Fully Characterised
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)
- 16 Week Tumorigenicity Assay in Adult Nude Mice (GLP)
Documentation of all tests performed, and test results are available at a data site.