Rapid IV formulation development for FIH ADME study

A top 10 pharma partner contracted ICON to perform formulation development for a first-in-human (FIH) ADME study after organisational changes prevented them from conducting formulation in-house. ICON’s Accelerated Pharmaceutical Solutions (APS) team provided assistance and performed the development in close collaboration with the sponsor.  Within six weeks, the team tested over 10 potential formulations to meet sponsor requirements. They screened and selected the most effective IV formulation, created analytical methods, and conducted stability and compatibility testing.Subsequently, we advanced the CMC process through method validation and the preparation of a technical batch to test the manufacturing process and collect stability information. An investigational medicinal product dossier (IMPD) was then compiled for regulatory submission within the agreed timelines.

Timelines to develop a suitable formulation to support the clinical study are often extremely short. A major hurdle is the rapid screening and delivery of formulations that not only meet timeline goals but also minimise the costs associated with the manufacture of radiolabelled drugs.  In this project, the sponsor requested a high level of control over formulation development, requiring ICON to test all formulations and advance the manufacturing process while strictly adhering to the client’s procedural workflows and stringent requirements.

The Accelerated Pharmaceutical Solutions team leveraged their deep expertise to identify an initial set of potential formulations tailored to the radiolabelled drug product and its delivery method. Within just a few weeks, over ten formulations were evaluated, adhering strictly to both sponsor protocols and our internal standards. Utilising our in-house radiolabelling equipment, we ensured enhanced efficiency and control throughout the process. In close collaboration with the sponsor, we ultimately selected the most suitable formulation for further development.

In parallel with rapid formulation testing, ICON also identified, implemented, and evaluated the most appropriate analytical methods for the selected formulation. Given the tight timelines required to meet study submission deadlines, a swift and coordinated approach was essential. To facilitate this, we developed a validation protocol outlining the method and validation strategy, fully aligned with ICH guidelines and sponsor-specific requirements. Upon receiving sponsor approval, the plan was executed within one week.

The next phase involved drafting the necessary manufacturing and analytical documentation to support the preparation of a technical batch. This batch was designed to simulate the intended clinical conditions and confirm that the developed process was fit for purpose in supporting the  clinical conduct. During this stage, the team also conducted a stability assessment to ensure coverage for the clinical study period and performed compatibility testing. The technical batch was then swiftly manufactured and successfully analysed within one week.

 Following sponsor review and approval of the raw data and results, the relevant information—including stability and compatibility data—was compiled into an Investigational Medicinal Product Dossier (IMPD) for regulatory submission. Upon receiving regulatory approval, the APS team will support the manufacture of the IMP for the upcoming first-in-human clinical study, which is also being conducted by ICON. 

Integrated formulation development, screening, and optimisation services—delivered through our centralised Accelerated Pharmaceuticals program—enabled the identification of an optimal formulation for a FIH ADME study involving a radiolabelled drug product. ICON’s close collaboration with the sponsor, seamless adoption of sponsor-specific operating procedures, and ability to develop a suitable formulation within accelerated timelines helped prevent costly delays to the global development program.

Learn more about our comprehensive Accelerated Pharmaceutical Solutions and how ICON’s experts can support the development of optimal formulations for your clinical trial.