cGMP Manufacturing of Biopharmaceuticals
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 pre-clinical, clinical and commercial phases.
Company Services
- 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)
- Flexibility, we match your timelines and respond to unexpected project needs
Product Experience
- Commercial API manufacturing in various scales (g to kg)
- Antibody fragments, cytokines, enzymes, etc
- Plasmid DNA, recombinant subunit and attenuated vaccines
- 300+ GMP batches
- 70+ molecules
Resources
- Biosafety Level 2
- 600 m2 Process development
- 600 m2 cGMP production
- 200 m2 Quality Control
- Fermenters include 50, 100, and 500 L
- Qualified equipment
- Class A - D production environments
- 6 production units in 3 suites
- 100 % renewed air system
- On-site WFI system
- Dedicated Project Managers
- On-site Qualified Person (QP)
- cGMP accreditation
Summary
One-stop-shop for cGMP biopharmaceuticals
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For contact information, please refer to the Help & Technical Support page. |
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