GMP Services
ONLY THE BEST FOR YOUR MOLECULE
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. 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
- ICH conform stability testing
- Testing of raw materials and facility supply (e.g. water, clean steam, WFI)
- Characterization of cell banks
All documentation conforms to eCTD and can be directly used for your application.
(customer from a big Pharma company)
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Analytical development at Richter-Helm 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-Helm BioLogics include recombinant proteins and peptides, antibody-like scaffolds (VHH/Nanobodies, Fab-fragments), plasmid DNA, and bacterial vaccines.
