API clinical trial material manufacturing services

Integrated API clinical trial material development and manufacturing services

Our extensive network of state-of-the-art lab and small-scale synthesis plants are fully equipped to exclusively develop and manufacture API for early and late stage clinical trials.  

We produce clinical trial materials for complex APIs and intermediates requiring multi-step synthetic processes from milligrams to tonnes, supporting clinical trials from pre-clinical through to Phase III and launch. Global API clinical trial customers are provided services from our Visp CH and Nansha CN sites, both of which are fully equipped to support development work through to commercial scale production.

API CTM Resources

Our project managers and chemical development service teams - comprised of small molecule product development, manufacturing support and analytical services – work collaboratively with customers to ensure that phase-appropriate clinical trial material requirements are met for drug programs.  We have more than 200 scientists (PhD, MSc and BSc level qualifications) supporting all aspects of drug substance development and clinical trial material manufacture for APIs.

Our R&D and kilo labs support process development, sample preparation for drug substances and intermediates for early stage clinical trials. Small scale and mid-scale plants are also in place which support early and later phase clinical trial material production, as well as low-volume commercial quantities to batch quantities up to 150kg. Multiple reactors are in place to support an extensive range of chemical synthesis technologies including organometallic reactions, oxidations, reductions, highly reactive and hazardous chemicals, asymmetric reactions and reactions under special conditions. 

Particle engineering capabilities at lab and pilot scale are also available for particle size reduction and spray dry processing of drug substances as required to meet desired API characteristics and target drug product profiles.

Flexible API clinical trial material development and cGMP assets to support your chemical synthesis from concept to commercial 

As part of our comprehensive product development for drug substances and intermediates, we provide phase-appropriate clinical trial material for feasibility studies, early and late phase clinical trials. In addition to R&D and kilo-Lab capabilities in both our Visp (CH) and Nansha (CN) facilities (10-30L vessels), we have dedicated small-scale and launch-scale facilities to support early stage and late-stage clinical trial programs, respectively.

Specialized HPAPI R&D labs and small scale plants are based in Visp to support early phase clinical to low volume commercial production of potent compounds (to OEL ≥ 1ng/m3) and ADC payloads.

Clinical Trial Material Labeling and Quality Requirements

Our R&D pilot plants and small scale plants adhere to strict global quality standards and facilitate seamless technical transfer into our launch and commercial scale facilities. Our QA and regulatory services team provide all data, information and support required for the CMC portion of regulatory findings.

Our plant network for small molecules - API, particle engineered intermediate and drug products - operates to stringent global quality standards and has an excellent regulatory inspection record inclusive of the FDA, SwissMedic, MHRA and ANVISA. We are fully equipped to supply your clinical trial material with specialized packaging and services to support global clinical trials.