CTM Manufacturing for drug substance, particle-engineered intermediates and drug product.
As part of our integrated product development services, we supply clinical trial material across small molecule applications for early and late phase clinical trials.
Clinical trial material (CTM) is manufactured in phase-appropriate assets for early and late phase clinical trials across oral, parenteral or inhaled applications.
- Drug substances – GMP intermediates, drug substances based on a full range of chemistry and inclusive of HPAPI and ADC payloads
- Particle-engineered intermediates – micronized compounds, spray-dried compounds or dispersions, hot-melt extrudates
- Finished drug products – immediate and modified release tablets, encapsulated multiparticulates or powder-based formulations
Small-scale processing is in place to supply material for non-GMP feasibility studies and CTM for cGMP development and clinical trial studies. Launch and commercial-scale production is also in place to support late-phase clinical supply and commercialization of drug substance, intermediates and/or finished drug products. Rapid development, scale-up and commercialization is facilitated with phase-appropriate scale and the option for integrated services.
Our CTM drug product supply is complemented with a full range of clinical supply services inclusive of primary and secondary packaging, labelling and kitting, distribution and returns management. Take a video tour of our Tampa facility to learn more about these global clinical supply capabilities.