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 complex APIs and intermediates requiring multi-step synthetic processes from milligrams to tonnes in support of clinical trials from pre-clinical through to Phase III and launch. Global 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.
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 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.
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 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.