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

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