Accelerated Pharmaceutical Solutions
Save money and reduce your drug development timelines
End-to-end solutions for integrating manufacturing and clinical conduct
ICON’s Accelerated Pharmaceutical Solutions deliver an integrated approach for small molecules and biologicals to formulation development. We offer end-to-end services from formulation development, screening and optimisation, analytical method development and phase appropriate validation, through to custom packaging, labelling, and distribution. This includes oncology products and carbon 14 labelled products.
ICON’S GMP-compliant manufacturing sites, both including GMP 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.
Solutions:
Formulation development and screening
Extensive formulation experience that results in speedier formulation development.
Formulation optimisation
By creating a design window of fixed compositions of a formulation we will investigate which is giving the best exposure and therefore identify the optimal formulation.
Analytical method development and phase appropriate validations
ICON’S GMP laboratories provide comprehensive analytical testing support for active pharmaceutical ingredients (API), intermediates, raw materials, in-process samples and finished products for all dosage forms of small and large molecules across all phases of drug development. Support for a variety of methodologies ranges from phase appropriate analytical method development and validation to transfer of existing assays.
Stability storage and testing
Stability can be conducted under various ICH controlled conditions by means of climate chambers for accelerated stability conditions or frozen, refrigerated or controlled room temperature.
Compatibility assessments
We evaluate compatibility with common contact points for the drug product including dose containers,(eg syringes, i.v. bags) and ancillaries for administrations (e.g. cannula’s,three-way valves etc).
Small scale manufacturing and release testing
Including tablets, capsules, oral solutions/suspensions, aseptic sterile formulations, topicals, nasal sprays, radiolabelled formulations.
Packaging and labelling
Primary and secondary packaging for all clinical phases, including labelling in local languages and according to local regulations.
Depot and distribution
Enables ICON’smanufacturing unit to ship to virtually any clinic or hospital around the world.
QP services
ICON has Qualified Persons on their MIA (Manufacturing Import Authorisation) who can support QP declarations/ audits and final release of the IMP.
Delivering benefits to your trial
ICON has more than 20 years of experience providing GMP services in United States and Europe. Our Accelerated Pharmaceutical Solutions can save you money and reduce your timelines with the following benefits:
Development of formulation(s) to meet the objectives of the early clinical phase
Customised formulations tailored to your clinical phase objectives, expediting the development timeline, reducing costs, and accelerating progression through clinical trials. This ensures faster delivery of study data, and speedier progression to the next phase.
Formulation optimisation that will show which composition is delivering the best PK levels in your study participants
Our formulation optimisation process identifies the most effective composition to achieve optimal pharmacokinetic (PK) results, enabling better decision-making and increasing the likelihood of clinical success. This approach helps to streamline the trial process and reduce trial iterations, ultimately saving time and costs.
Real-time dose flexibility
We support ad hoc dose adjustment based on safety data, allowing you to quickly adapt and manufacture clinical batches to changing dose needs without delays in a matter of days/weeks. This not only speeds up trial adjustments in between cohorts, but also ensures more accurate dosing, improving trial outcomes.
Manufacturing and testing of IMPs under GMP conditions
We ensure the highest quality and regulatory compliance by manufacturing your Investigational Medicinal Products (IMPs) under GMP standards. This guarantees the quality and safety of your products.
Integrated CMC services and Qualified Person (EU)/Quality Assurance (US) release that supports rapid distribution route to the clinical sites
Our integrated Chemistry, Manufacturing, and Controls (CMC) services, in-house QC release testing, including QP release, provide a streamlined pathway for faster distribution to clinical sites.
Manufacturing and stability studies can be conducted quickly to evaluate formulation candidates
The rapid execution of manufacturing of (technical) confirmation batches and concomitant stability studies allows for quick evaluation of any formulation. Where required this can be performed in parallel.
Fast turn-around of clinical data
Rapid clinical data feedback enables faster decision-making and trial adjustments. This accelerates clinical development, reduces time-to commercial release, and minimises costs associated with prolonged trial durations.
CMC services (manufacturing and regulatory) for high-risk and radiolabeled IMP
With our specialised CMC services for high-risk and radiolabeled IMPs, you benefit from expert handling of complex products. ICON supports management of radiosynthesis of drug substance and overall drug product development and manufacturing for often small subject/patient groups.
Less stability data needed to support the potentially shortened duration between manufacturing and dosing of IMP, enabling an earlier clinical trial start
By requiring less upfront stability data, you can initiate clinical trials sooner, saving both time and costs associated with extended stability testing. This enables quicker trial commencement, accelerating product development and increasing competitive advantage.
Microtracer formulations, including microdose, can be applied
Take advantage of microtracer formulations, including microdoses, to support your aBA and ADME studies. ICON has extensive experience in finding solutions to optimise formulations to ensure a high level of dosing accuracy.
Find out more:
Discover how ICON's Accelerated Pharmaceutical Solutions can enhance your clinical trials