Clinical Trials and Commercial Manufacturing
At Aptuit we understand how valuable your drug substance is and how difficult the choice of which facility to perform cGMP manufacture can be. Our cGMP manufacture departments can produce a wide range of solid and liquid dosage forms, from Phase I to Phase IV of the drug development program alongside commercial drug products.
Our cGMP manufacture services include warehousing at various conditions (ambient, walk-in refrigerator, –20°C and –70°C freezers), materials receipt and inventory control, bulk manufacture (stability trials, clinical trials and commercial supply) and shipment of bulk drug products and samples. Our flexible approach to manufacturing ensures that your drug products are manufactured within your timelines to the highest quality standards
We can offer a range of innovative and market leading technologies to improve your cGMP manufacturing experiences including:
- Liquid filled hard gelatin capsules using LEMS technology including CFS1200 and LEMS 30
- Precision dosing: manual or automated filling of drug substance including Xcelodose® 600 and 600S and autodose capsule filling
- High speed overencapsulation using MG2 Planeta technology
- Manufacture of highly potent and cytotoxic material using either our Potent Drug Suite (PDS) based in our Kansas City facility or our fully validated flexible film isolator technology for existing manufacturing equipment
Our scientists and project managers understand the sheer complexity of your drug development programs and aim to match the demand for your clinical trial materials with provision of drug product and can offer a seamless linkage of activities across our whole business.