At BioChem Oss, your Biochemical CDMO or CMO API project is in excellent hands. With our competencies we can add value to your project and collaborate with you to ensure success. We have a proud, century-long history in development, up-scaling and commercially manufacturing Biochemical APIs – as well as an extensive international network in both industry and academia.
Examples of our expertise
Biochemical services
- Direct contact with our Subject Matter Experts
- Professional project management
- Route selection
- Process development and optimization
- Analytical development and validation
- ICH stability studies
- Extensive sourcing network for raw materials
- Global regulatory expertise and support
Technology platform
Extraction and (chemical) modification of complex biologicals (heparin/heparinoids; glycosaminoglycans (GAG’s) using:
- Large scale enzymatic digestion and precipitation
- Ion exchange chromatography
- Ultrafiltration
- Oxidation
- Heparin isolation and purification
- Virus- and prion removal/inactivation
- Virus filtration
- Filter drying
Chemical and enzymatic modification of heparin and heparinoids. Non-anticoagulant heparin, Heparinoids, Heparan sulfate, Dermatan sulfate, Hyaluronic Acid.
Of most of these technologies, validated down scale lab versions are available. E.g. :
- ÄKTA lab scale purification system
- Labscale ultrafiltration facilities
- Downscale of most other biochemical manufacturing methods.
- Downscale reactor systems with different analytical probes
Biochemical API analytical development equipment/analytical capabilities
- EIA
- Activity assays
- Electrophoretic techniques
- Enzymatic analyses
- Bioburden
- Endotoxins
- qPCR
- Spectrophotometric determinations
- HPSEC
- Pharmacopoeial testing
- NMR
Biochemical API manufacturing capabilities
- Enzymatic conversions
- Fermentation