Rapid IV formulation development for FIH ADME study

A top 10 pharma partner engaged ICON to conduct formulation development for a first-in-human (FIH) ADME study after organisational changes limited their ability to perform this work in-house. ICON’s Manufacturing & Pharmacy Services team collaborated closely with the sponsor to deliver the programme. Within six weeks, the team evaluated more than 10 potential formulations to meet study requirements. They identified and selected the optimal IV formulation, developed analytical methods, and conducted stability and compatibility assessments. The CMC programme was then advanced through method validation and the preparation of a technical batch to support manufacturing process evaluation and stability data generation. An investigational medicinal product dossier (IMPD) was subsequently compiled for regulatory submission within the agreed timelines.

The development window for creating suitable formulations to support clinical studies is often highly compressed. A key challenge lies in rapidly screening and delivering formulations that not only meet these tight timelines but also minimise the costs associated with manufacturing radiolabelled drugs. In this project, the sponsor also required a high degree of oversight and control throughout formulation development, directing ICON to evaluate all candidate formulations and advance the manufacturing process while strictly adhering to the sponsor’s procedural workflows and stringent requirements.

The Manufacturing & Pharmacy Services 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, we 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 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 Manufacturing & Pharmacy Services and how ICON’s experts can support the development of optimal formulations for your clinical trial.