Clinical Trial Material Manufacture, CTM Supply

Drug Substance, Intermediates and Drug Product

We offer small-scale processing for non-GMP feasibility studies and cGMP development for clinical trials. For launch, we offer commercial-scale for drug substance, intermediates and drug products.

A Full Range of Clinical Supply Services

Our full range of clinical supply services includes: primary and secondary packaging, labelling and kitting, distribution and returns management.

CTM in our Phase-appropriate Assets

Clinical trial material is manufactured in phase-appropriate assets for early and late phase clinical trials across oral, parenteral or inhaled applications.

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 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

Supplying material for non-GMP feasibility studies and CTM for cGMP development and clinical trial studies

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 are also in place to support late-phase clinical supply and commercialization of drug substances, intermediates or finished drug products. Rapid development, scale-up and commercialization are 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. These services include primary and secondary packaging, labelling and kitting, distribution and returns management.

Equipped to support non-GMP feasibility studies

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

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.

Equipped to support non-GMP feasibility studies

As part of our integrated service offer, we provide specialized oral drug products in addition to drug substances and particle-engineered drug product intermediates. Our integrated services ensure that you can utilize one partner from concept through clinical studies and commercialization, thereby reducing program times, complexity and risk. Our specialized drug products, often utilizing enabling technologies to improve bioavailability and/or modulate pharmacokinetics, include: