Cell Banking and Virus Production
Charles River has more than 20 years of experience in manufacturing cell banks and our processes have been developed from this large base of experience to ensure a successful outcome for your manufacturing campaign.We are also able to provide services for small scale virus and vaccine manufacturing.
Charles River offers many support services in order to expedite the receipt of your cell/virus seed stocks and production of your cell bank. If necessary, our team of experts is able to offer assistance with import permits and provide appropriate shipping vessels. After the seed stock arrives, our project management team will guide you through the manufacturing process from pre-seed testing and generation of the manufacturing batch record through to the manufacture, release and characterization testing of the cell or virus bank. It is our top priority to make sure you are kept informed throughout the manufacturing process.
Mammalian, Insect, Avian and Stem Cells
Our cell banking team is capable of producing up to a 1,000 vial cell bank in cGMP-compliant suites. To provide the best timelines for you, we have multiple cell banking suites available for manufacture. Standard release criteria of viability and sterility are provided, and full characterization and biosafety capabilities are also available for further regulatory-based testing of your cell bank.
Microbial Cell Banking
Our microbial cell banking team has a wealth of experience in manufacturing E. coli, yeast, and other aerobic and anaerobic microbial cell banks to the highest standards. As with our mammalian cell banks, microbial cell banking services are conducted under appropriate controlled conditions. We have dedicated, fully equipped cGMP-compliant suites with the capability to produce up to an 800 vial cell bank.
Virus/Vaccine Production
Charles River can help you expedite your vaccine development program by providing you with manufacturing for early-phase clinical trials through to lot release (potency assays) for commercial products. We also provide biosafety testing for virus seeds stocks and vaccine products which is essential to ensure no bacterial, fungal, mycoplasma or adventitious viral agent contamination is present. In addition, we provide immunogenicity and adjuvant assessment, as well as the complete microbiology and in vivo services necessary for vaccine efficacy testing.
Vaccine/Virus Manufacturing Services Include:
- cGMP virus seed and cell banking
- Vaccine manufacturing via cell culture and SPF eggs
- Vaccines for clinical trials (manufacturing scale – up to 4,500 vials per batch)
- Pilot scale virus manufacturing
- Adaptation of production using animal component free reagents
- Ability to work with clients to optimize processes and raise titers