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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 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.


Examples of capabilities in microbial biologics manufacturing:

  • Recombinant proteins and protein complexes
  • Plasmid DNA
  • Vaccines

Examples of cell line capabilities:

  • E. coli
  • P. pastoris
  • Other

Track record in Recombinant Protein Development and Manufacturing

  • Biovian has been developing Microbial processes since 2003.
  • Over 100 clinical Drug Substance and subsequent Drug Product batches have been manufactured, including cell banks.
  • All clinical phases – Phase I to Phase III
Track record in microbial production – Video
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 One-Stop-Shop CDMO services 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.

Examples of One-Stop-Shop capabilities

Cell Banks

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

Upstream Processes

  • Stirred Tank bioreactors – up to 200 L
  • Fermentation of a wide range of bacteria and yeasts 
  • Target protein/Inclusion body expression
  • Harvesting with Tangential flow filtration or continuous centrifugation
  • Cell homogenization
  • Enzymatic treatment
  • Harvest clarification with TFF, continuous centrifugation or deep filtration

Downstream Processes

  • Protein denaturation/Refolding
  • Chromatographic purification options
    • AIEX
    • CIEX
    • Multimodal
    • SEC
    • Column and membrane chromatography
  • Tangential Flow Filtration

Aseptic Fill and Finish

  • Formulation and final Drug Product manufacture
  • Automated aseptic filling lines with RABS
  • Filling in vials – 2R and 10 R
  • Typical batch sizes 400 – 4000 vials – up to 10 000vials

Quality Assurance and  Quality Control 

  • Product-specific assays
  • Compendial analyses, Ph. Eur
  • Microbiological QC and safety assays (sterility, bioburden, endotoxin etc.)
  • QP certification and full GMP documentation

Analytical services, QC, and safety assays

Analytical testing and analytical method development are a central part of Biovian’s CDMO services. Our team of experts develops and validates product-specific QC tests. Compendial specification analyses and QC tests for sterility, bioburden, and endotoxin, are routinely performed in-house. We also perform validation of microbiological product-specific assays.

Examples of product-specific assays

  • Concentration 
  • Identity
  • Purity
  • Impurity
  • Potency
  • Cell-based assays

Examples of compendial specification assays

  • Appearance 
  • pH
  • Osmolality
  • Sterility 
  • Visible and subvisible particles 
  • Clarity
  • Colour
  • Residual reagents

Examples of microbiological QC and safety assays 

  • Sterility testing
  • Bioburden (TAMC/TYMC)
  • Endotoxin testing

Download a Microbial Production flyer

Download
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
Eero Mustalahti
Manager, Sales and Business Development