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Microbial Biopharmaceutical CDMO

Biovian is a One-Stop-Shop CDMO for bacterial and yeast-based production of Drug Substances and Drug Products. Our services include GMP production of recombinant proteins and of plasmid DNA for vaccines, as well as Viral Vector applications for those gene therapies, where plasmid DNA constructs serve as key raw material. 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.

Examples of the capabilities of Biovian in Microbial Biologics manufacturing:

  • First-in-class biopharmaceuticals
  • GMP-grade Plasmid DNA
  • Vaccines
  • Recombinant proteins and protein complexes
My experience with Biovian is based on one long-term project that includes both Drug Substances and Drug Products. Biovian has been a good partner. The project, comprising development and several technical and GMP batches, were on time and within budget over a period of 5-6 years – I believe that could be a world record!
CEO, consultant

One-Stop-Shop CDMO in Microbial Biologics Production

Our clients will be offered a true One-Stop-Shop GMP CDMO service in microbial biologics production, with modular services available across the supply chain and across the value chain. The One-Stop-Shop supply concept covers solutions from analytical and Drug Substance process development to Drug Product Fill and Finish, including Qualified Person approved release, making your CMC-journey easier.

Cell Banks

  • Research Cell Bank (RCB)
  • Master Cell Bank and Working Cell Bank (MCB / WCB)

Upstream Processes

  • Capacity up to 200 L in stirred stainless steel tank
  • Fermentation of wide range of bacteria (aerobic, anaerobic)
  • Tangential flow filtration units for harvest clarification and further processing
  • Homogenization

Downstream Processes

  • Comprehensive purification solutions – refolding chromatography, membrane processes, Tangential Flow Filtration processes

Aseptic Fill and Finish

  • Formulation and final Drug Product manufacture
  • Two Automated Filling lines, Filling in vials
  • Typical batch sizes 400 – 4000 vials

Quality Assurance and Quality Control

  • Product-specific assays
  • Impurity analyses
  • Cell-based assays
  • Microbiological QC and safety assays (sterility, bioburden, endotoxin etc.)
  • QP Certification and full GMP documentation
Cell and Virus Banking Services
Next step

Cell Bank and Virus Seed Stock

Biovian provides microbial, mammalian and insect cell GMP cell bank manufacturing according to current regulatory guidelines.

Contact Us

Antti Nieminen
Director, Business Development and Projects
Magnus Gustafsson_Biovian
Magnus Gustafsson
Head, Global Business Development
Eero Mustalahti
Manager, Sales and Business Development