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As part of our integrated product development services, we provide clinical trial material across small molecule applications for early and late phase clinical trials.

Clinical trial material (CTM) is manufactured for early and late phase clinical trials across oral, parenteral or inhaled applications.

  • Drug substances – intermediates, drug substances based on a full range of chemistry including HPAPI and ADC payloads 
  • Drug-product 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, liquid-filled hard capsules and softgels

Small-scale processing is in place to provide CTM for non-GMP feasibility studies and 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 this phase-appropriate scale and the option for integrated services.

We have 9 GMP custom manufacturing facilities around the globe for the manufacture of clinical-trial material (CTM) across our integrated product development service options.

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

technology
Micro-dosing for Powder-in-Capsule / Powder-in-Bottle Studies
Micro-dosing is the process of dispensing a precise amount of drug substance into a capsule (or other container, e.g. vial or bottle), for use in early phase human studies (phase I safety evaluations). This powder-in-capsule (PIC) or powder-in-bottle (PI...
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Micronization & Jet Milling
Particle size reduction is increasingly utilized to address a range of formulation issues facing oral solid and inhaled dosage forms. Stability, flowability, dissolution rate and bioavailability are critical performance parameters impacted by particle siz...
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Multiparticulate Technologies
We utilize four multiparticulate technologies for meeting target product profiles, with the choice being dependent upon API parameters, formulation requirements and commercial objectives.
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SimpliFiH® Solutions: First-in-Human Services
We can provide integrated drug substance and drug product services for preclinical studies and phase I clinical trials.
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Solid Dispersion Technology
Amorphous solid dispersions are a proven approach to alter the properties of APIs for improved dissolution rate, solubility and overall bioavailability.
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Pediatric Product Development
We provide specialized product development for pediatric and geriatric populations.
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API Clinical Trial Material Manufacturing Services
We provide exclusive chemical synthesis services for early and late stage clinical trial material.
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HPAPI Product Handling
We have specific capabilities, infrastructure and expertise in handling highly potent API (HPAPI) compounds.
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Modified and Targeted Delivery
We utilize a full range of established modified release technologies, often in combination with solubility-enhancing technologies, to meet target product profiles.
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ADC Payload Product Development
We can provide a full-service offering for antibody-drug conjugates (ADC) inclusive of ADC payloads, monoclonal antibodies, linkers and bioconjugation services.