DSM Biologics’ cGMP facility in The Netherlands has a strong track record with a range of cell lines.
Our cGMP facility in Groningen, The Netherlands has a strong track record with a range of cell lines, including CHO, Hybridoma and PER.C6® cell line. We also have considerable experience using multiple manufacturing and purification techniques, including batch, fed-batch, continuous perfusion, and our proprietary XD® technology. Whether you are poised for preclinical development, clinical trials or commercial production (up to 1000L) our scientists and researchers can bring your project from concept to completion successfully.
Capabilities:
- Mammalian manufacturing platforms including CHO, Hybridoma and PER.C6® cell line
- XD® technology
- RHOBUST® (expanded bed absorption)
- Preclinical, clinical and cGMP commercial manufacturing
- Batch, fed-batch and continuous perfusion
- Process development, optimization and scale-up
- Downstream processing
- Process validation
- Purification chromatography
- Analytical development
- Integrated secondary manufacturing
Track Record
| EMEA | FDA |
| Certified 1994 for cGMP manufacturing | Qualified during Pre Approval Inspections (PAI) since 1997 |
| Last inspection April 2010 | Qualified for manufacturing of licensed product post PAI of 01/2004 |
| | Re-qualified after routine cGMP inspection November 2005 |
| | Last inspection July 2010
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PER.C6® is a registered trademark of Crucell Holland B.V.
XD® is a trademark of DSM N.V.
RHOBUST® is a trademark of DSM N.V.
