Analytical method development and validation
Our service offering comprises the development of a wide array of analytical methods for parenteral drug product, including, but not limited to, purity (size, charge based) such as SE-HPLC, RP-HPLC, iCE280 and CE-SDS, identity, content, bioassays (cell-based, ELISA, others)and pharmacopeial testing.
We have successfully developed analytical methods for standard monoclonal antibodies, bispecifics, other recombinant proteins, fusion proteins, antibody-drug-conjugates, vaccines, as well as viral-and cell-based therapies.
Our experts have extensive experience with the validation of methods and work closely with our drug substance sites to enable method validation and co-validation, as appropriate. We provide a fully integrated, end-to-end service.
Access comprehensive QC contract laboratory services
Drug product QC release and cGMP drug product stability testing is performed according to ICH guidelines. Our analytical experts work proactively with our customers to plan and execute GMP activities to enable clinical and commercial testing.
We can help to define shelf-life, specifications and develop a drug product control strategy for IND/IMPD or BLA/MAA, and design quality-by-design and breakthrough therapy submissions.
Our state-of-the art specialized analytical testing labs support:
- Fast-track particle root cause investigation in drug product processing and manufacturing
- Extractable and leachable characterization
- Excipient degradant characterization (e.g. Polysorbate degradation)
- Container closure system requirements, design and qualification and CCI testing
- Particle characterization
- Submicron and subvisible particle characterization
- Development of a particle control strategy