Cell Bank Manufacturing
Biovian provides microbial, mammalian, and insect cell GMP cell bank manufacturing according to current regulatory guidelines. Master Cell Banks, MCBs, are prepared using RCBs as starting material. Working Cell Banks, WCBs, are prepared from the MCBs under defined cell culture conditions and are used for the production of innovative biopharmaceuticals or gene therapy applications. We provide your project with our experience with several adherent and suspension cell lines e.g. E.coli, HEK293, CHO, A549, Vero, CAP, and Sf9. Biovian has dedicated, environmentally controlled manufacturing facilities for both mammalian and microbial cells. Our EMA-certified and FDA inspected facilities, including all storage equipment, are continuously monitored and equipped with alarm systems.
Our Cell Bank services cover the following:
- Generation of RCB
- GMP-compliant MCB and WCB manufacturing
- Dedicated cleanrooms for the preparation of mammalian and microbial Cell Banks
- Programmed and controlled freezing of cells
- GMP-compliant storage of MCB and WCB in a liquid nitrogen vapor phase storage system or in an Ultra-Low Temperature Freezer
- 24/7 monitoring of facilities
- Flexible shipments to other sites
- Full characterization service of Cell Banks, conforming with major compendia and regulatory guidelines
Virus Seed Manufacturing and Storage
Biovian provides research Virus Seed stock (RVSS) preparation from plasmid to virus. The manufacturing and storage, under GMP conditions, of high-quality master and working virus seed stock (MVSS/WVSS) provides robust starting materials for Viral Vector and Vaccine projects. Virus Seed manufacturing and banking are performed in dedicated clean rooms ensuring that there is no cross-contamination. We have full capabilities for the preparation of adenovirus and other BSL2 class Virus Seed stocks to support you in your gene therapy, immuno-oncology or vaccine projects.
Our Virus Seed services cover the following:
- Generation of RVSS
- GMP MVSS and WVSS manufacture (BSL2)
- Dedicated clean rooms for viral and non-viral bank preparation.
- GMP storage of MVSS and WVSS in Ultra-Low Temperature Freezer
- 24/7 monitoring of facilities
- Flexible shipments to other sites
- Full characterization service of Virus Seed conforming with major compendia and regulatory guidelines
