Microbial Production CDMO

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.