Biosynth GmbH offers the manufacture of bioconjugates from µg through multi gram scale. Different formal quality levels may be applied for the production of active pharmaceutical ingredients (API), depending on the intended purpose of the product.
The manufacture of proof-of-principle (PoC) or Tox material is typically carried out following standard operating procedures (SOPs) that have been generated during process development. Drug substances for first clinical trials in humans is produced according to the EU-GMP guidelines part II: Basic Requirements for Active Substances used as Starting Materials. Irrespective of the formal level, celares always provides the highest possible quality and does not compromise the technical quality of a product.
Scope of work:
- Establishment of process and documents
- Establishment of analytical methods for incoming goods testing
- Purchase and testing of starting materials
- Campaign production of bioconjugate in cleanroom
- Release testing and certificate of analysis
- Batch release of bulk API