cGMP Biopharmaceutical Services
A cGMP compliant manufacturer of biologics from bacterial and yeast sources, Eurogentec offers 10+ years of know how in the technology transfer, process development, scale up and manufacturing of proteins, plasmids and vaccines for
preclinical,
clinical and
commercial use.
Tools to success include:
- Design of experiments (DoE)
- Construct and optimisation of producer strain
- Technology transfer and process development
- Fermentation and downstream processing (DSP)
- Analytical transfer and development
- Process scale up and validation
- Validation of analytical procedures
- Cell banking and storage
- cGMP manufacturing of API drug substances and drug products
- Quality control
- Master Batch Record
- Quality Assurance and Regulatory Compliance
- Batch release
- Stability studies (accelerated, stress etc)
- Dedicated project
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