Examples of the capabilities in microbial biologics manufacturing:
- Recombinant proteins and protein complexes
- GMP-grade Plasmid DNA
- Vaccines
Examples of cell line capabilities:
- E. Coli
- P. Pastoris
- Other
Track record in Recombinant Protein Development and Manufacturing
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.
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 wide range of bacteria (aerobic, anaerobic)
- Inclusion body expression and recovery optimization (E. coli)
- Tangential flow filtration units or continuous centrifugation for harvest clarification
- Cell homogenization
- Protein denaturation
Downstream Processes
- Refolding
- Chromatographic purification
- Membrane purification
- 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
- Impurity analyses
- Potency assays
- Cell-based assays
- Microbiological QC and safety assays (sterility, bioburden, endotoxin etc.)
- QP certification and full GMP documentation
