ICON understands the need to rapidly respond to emerging data in the early learning phase of clinical drug development.
Our Accelerated Early Clinical Manufacturing services provide on-site Investigational Medicinal Products (IMP) development and manufacturing all in accordance with current Good Manufacturing Practices (cGMP).
With 20+ years of expertise in chemistry, pre-formulation and pharmaceutical development, our flexible, high quality accelerated early clinical manufacturing services have proven to be successful for increasing flexibility in dose escalation, shortening timelines, and reducing costs for IMP development and stability programs. We can also perform formulation optimalisation studies using our flexible dose approach which provides more accurate clinical study data, and a solid formulation to start the next stage of your compound.
ICON’S GMP-compliant manufacturing sites, both with Quality Control (QC) laboratories, are capable of formulation development and running stability/compatibility programs in parallel with the QC work for production. Within this setting, we offer accelerated early clinical manufacturing to support typical, high-risk, and/or radiolabeled IMP for early drug development in healthy volunteers and patient studies conducted within Europe and the US.
Delivering benefits to your trial:
Our flexible, high-quality Accelerated Early Clinical Manufacturing services can ultimately save up to $1 million in costs and 12 months in reduced timelines with the following benefits:
- Development of formulation(s) to meet the objectives of the early clinical phases
- Real time dose flexibility within a trial
- Manufacturing and testing of IMPs under GMP conditions
- Integrated CMC services and Qualified Person (EU)/Quality Assurance (US) release that supports a rapid distribution route to the clinical sites
- Manufacturing and stability studies can be conducted quickly to evaluate formulation candidates
- Fast turn-around of clinical data
- CMC services (manufacturing and regulatory) for high-risk and radiolabeled IMP are possible
- Less upfront stability data to support the potentially shortened duration between manufacturing and dosing of IMP
- Microtracer formulations, including microdose can be applied
- Formulation optimalisation will show which composition is delivering the best PK levels