ProBioGen GMP Manufacturing Services
ProBioGen holds a manufacturing authorization for GMP (Good manufacturing practice) compliant manufacturing and batch release of biotechnological drug substances and fulfills all present regulatory requirements by EMA and FDA. GMP Manufacturing Services include: Manufacturing of pre-clinical and GMP grade material Disposable bioreactor Technology, stirred tank bioreactors - Decreased risk of cross contamination - Reduce…
The supplier does not provide quotations for this product through SelectScience. You can search for similar products in our Product Directory.
ProBioGen holds a manufacturing authorization for GMP (Good manufacturing practice) compliant manufacturing and batch release of biotechnological drug substances and fulfills all present regulatory requirements by EMA and FDA.
GMP Manufacturing Services include:
- Manufacturing of pre-clinical and GMP grade material
- Disposable bioreactor Technology, stirred tank bioreactors
- Decreased risk of cross contamination
- Reduced time to get facility up and running
- Cost effective processes
- Fed batch processes and ATF - Quality control
- Monitoring of the process by in-process controls - Quality assurance
- Analytical methods for product characterization are developed and validated for release
- Transfer of analytical methods - Regulatory support (for IMPD/IND and MAA/BLA)
- We provide professional project management throughout all steps
