Pharmaceutical Development Services
WuXi AppTec’s pharmaceutical development services encompass a full range of services from pre-formulation development, formulation development, supporting analytical development, and clinical trials material manufacturing through to product registration services. The integration of these services helps to move NCEs quickly and seamlessly from preclinical to NDA filings.
Preformulation Development
Glatt Powder Coater & Granulator
- Services offered for preformulation include evaluation of intrinsic physicochemical properties of API, salt form selection, polymorphism study, powder characterization studies, such as particle size and flow properties, and drug excipient-compatibility studies.
Formulation Development
- Formulation development services cover the development spectrum, from early safety studies to toxicity studies, to dosage manufacturing to registration/clinical batches. Formulation stability can be evaluated at ICH or any customized storage conditions. Packaging and storage conditions are suggested based on thorough stability studies.
Instrument Highlights
- Our state-of-the-art PDS preformulation laboratories are equipped with modern analytical instruments, including laser diffraction particle size analyzer, DSC, TGA, DVS, XRPD, and dissolution testing stations.
IN-CAP Capsule Filling Machine
- The PDS formulation development laboratories are equipped with state-of-the-art fluid bed and high shear granulators, dry granulator, automated tablet press, automated capsule filling machine, autocoaters, weight sorter, metal detector, automatic blister pack machine, and bulk packing line. A microdozer with capability to fill from 100 micrograms to several hundred milligrams of API into capsules, bottles, or blisters also is available.
Clinical Trial Materials Manufacturing
- Our clinical trial material manufacturing services are designed for production of Phase I and Phase II materials. We currently manufacture solid oral (including liquid filled hard gelatin capsules) and liquid oral dosage forms. The facility complies with U.S. FDA and EMEA requirements.