Drug substance API
We reliably supply drug substance API from gram to Kilogram quantities in modern fully GMP compliant facilities to support your stability, formulation and toxicology studies as well as clinical trials. Alongside our manufacturing capabilities, Concept Life Sciences possesses extensive analytical capabilities to support characterization, batch release, and storage stability.
Concept’s process chemistry team will de-risk existing routes and provide reaction optimization, improve process robustness offering form control, stressing of process conditions and defining hold points.
Concept Life Sciences has a wide range of sized vessels (20L to 120L) to enable the manufacture of up to 10Kg of API as single batch. Furthermore, CLS has dedicated laboratories and containment systems equipped with drying ovens which allows for the manufacture of High Potency API (HPAPI).
Our chemistry team is supported with a comprehensive range of complementary services including pre-formulation, API characterization expertise and full GMP method development and validation.