API Drug Substance Manufacture
Active Pharmaceutical Ingredient (API) is a core discipline of Aptuit Laurus. We have the science and exceptional facilities to provide a wide range of cGMP APIs and intermediates from discovery through to clinical, contract and commercial scale manufacture. We also have the capability to produce multiple batches, working under varying conditions from cryogenic to high temperatures for highly potent/cytotoxic materials.
In house hazard evaluation expertise ensures accurate determination of possible scale-up problems at an early stage, mitigating risk and costly redevelopment at a later stage.
Our people are amongst the best in the industry with a broad depth of knowledge, and are experts at finding alternative chemistry that brings additional benefit to the project in terms of speed or flexibility.
At Aptuit Laurus, it’s all about the people.
Our services embrace:
- Manufacture of non-clinical/preclinical material under GLP conditions
(non-GMP)
- cGMP manufacture of clinical phase I/II/III APIs and intermediates
- Flexi-scale manufacture of non-potent molecules with reactor volumes
ranging from 10L to 7500L
- Fully contained facilities offering flexi-scale manufcturing of highly
potent/cytotoxic APIs with reactor volumes ranging between 50L and 3500L
- Large-scale commercial manufacturing capability
- Commercial scale cGMP manufacture of API and intermediates
- Contract development and manufacture of API and intermediates
Click here to learn more about our Highly Potent Manufacture - Containment Systems