Integrated Chemistry, Manufacturing and Control
Our truly Integrated Chemistry, Manufacturing and Control capabilities fully support drug substance and drug product development and GMP manufacturing from FIH to Phase III clinical development programmes on behalf of our partners around the world.
Our teams are composed of multi-disciplinary, industry-leading scientists who possess integrated knowledge of every step contained within CMC development activities, from laboratory to commercial scale for both API and drug product.
Straightforward, continuous processes from API to pre-clinical data and clinical supply enable end-to-end development of new chemical entities, without the need to align different providers.
This allows time optimisation and risk mitigation for each single development project, in the capable hands of our expert project management professionals.
Our integrated CMC capabilities include:
- API polymorph screening, salt-selection, co-crystals screening
- API route scouting, process development and scale-up
- API GMP manufacturing
- Solid state characterisation
