GMP Services
ONLY THE BEST FOR YOUR MOLECULE
Our on-site GMP laboratories uphold the highest standards of quality as required by EMA, FDA, Pmda, ANVISA and other regulatory bodies
With a team of highly qualified and motivated professionals (more than half of which have university degrees) we are ready to identify and apply the best solutions for your project. On a complete lab space of 1325 sqm you can also count on a whole battery of GMP-compliant quality control measures:
- Method transfer and validation
- Validation of analytical procedures according to ICH and USP
- Lifecycle management of your methods
- Platform-based methods that can be adapted to your product
- Verification of compendial procedures
- In-process and release testing of drug substances and drug products
- Comparability testing
- Microbiological testing acc. Ph. Eur. and USP procedures
- ICH conform stability testing
- Testing of raw materials and facility supply (e.g. water, clean steam, WFI)
- Verification of cleaning success by at least TOC
- Characterization of cell banks
All documentation conforms to eCTD and can be directly used for your application.
“The FDA approval paves the way for Richter BioLogics to serve the global market”
(customer from a big Pharma company)
L
This might interest you
Analytical development at Richter BioLogics is set up to establish state-of-the-art, fully compliant solutions for your molecule.
Pick your method from our large portfolio. All methods can be applied for development or GMP-compliant testing, depending on your needs.
The product types manufactured with microbial expression systems at Richter BioLogics include recombinant proteins and peptides, antibody-like scaffolds (VHH/Nanobodies, Fab-fragments), plasmid DNA, and bacterial vaccines.