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
