Biovian Oy services

Biovian is a One-Stop-Shop CDMO for bacterial and yeast-based production of Drug Substances and Drug Products. Our microbial production services include GMP production of recombinant proteins and plasmid DNA for vaccines. The microbial GMP-manufacturing unit of Biovian is equipped with state-of-the-art fermenters, harvesting equipment, and a choice of downstream purification capabilities. Manufacturing and purification options cover both secreted and intracellular products.

The state-of-the-art production facility allows for flexible viral vector production scenarios. The cleanroom class C (EU GMP) and biosafety level 2 facility is designed for the manufacturing of GMP-grade viral vectors. The space design follows a modular ballroom concept and unidirectional process flow. The equipment are mobile, allowing for easy reconfiguring, and the operations are performed according to one-way process principles from incoming to outgoing material. Production is campaign-based – a single product is produced at a time, and disposable materials and closed systems are used. Open processes are executed in biosafety cabinets with HEPA 14 filters, with air exhaust directly out of the building.

Biovian provides comprehensive viral vector process development services that are fully integrated with process analytics. Our process development services support the Quality-By-Design (QBD) approach from the earliest possible stage in order to enable a straightforward transition to GMP production.

Adenoviruses are attractive tools for gene therapy, including immuno-oncology, because of their well-defined biology and characteristics including the possibility for large gene inserts. Biovian has proven expertise in adenovirus vector process development, GMP production, and analytics. Since 2004, we have developed processes and have manufactured over 40 clinical adenovirus GMP batches for our clients. Biovian supports adenovirus vector production in both adherent cell cultures and suspension cell cultures. Scalable technologies enable a straightforward transition to GMP production. Sourcing GMP-grade raw materials and consumables from qualified material providers are included in the services. The One-Stop-Shop concept is finalized with bio-safety level 2 class aseptic filling in a grade A/B production suite, followed by clinical labeling, GMP storage, certification of GMP compliance and Qualified Person (QP) approved release.