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.

Take a video tour of our Tampa site showcasing the investments in expanded capacity and capabilities to rapidly progress your molecules. The video overviews site services from feasibility studies through clinical oral drug product supply and distribution services, to commercial manufacture.

View the Tampa site video

Clinical trial material manufacturing

We are equipped to support non-GMP feasibility studies in addition to manufacturing phase-appropriate cGMP CTM thereby facilitating rapid advancement of your compound.

Specialized facilities are also in place to process high-potency drug compounds and to handle solvent-based processes, such as spray drying and spray-layered technology for multiparticulates. Analytical services and extensive process-development expertise ensure that the scale-up of processes is efficient and seamless.

In addition, full product development support is available on site, including GMP-compliant analytical laboratories, primary and secondary packaging services to support Phase I-V clinical projects, along with overall CTM worldwide distribution and storage services.

Technologies and products

related content

Lipid-Based Formulations for Early Stage Clinical Trials
Webinar on-demand
Manufacturing Amorphous Solid Dispersions by Spray-Drying: Scale-Up Approaches
Webinar slides
Micro-Dosing and Powder-in-Capsule Evaluations
Tech brief
Solid Dosage Manufacturing, Packaging and Distribution
Tech brief