Microbial Biopharmaceutical 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

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