Case Study: Investigational Product Project
Project management is a key success factor in radiopharmaceutical development. It ensures the coordinated management of all project phases – from the initial concept through development and manufacturing to clinical application. Using an investigational product project as an example, we outline the individual steps and milestones of a typical development process.
Radiolabeling
- Development of a robust radiolabeling procedure with [¹⁷⁷Lu] for a small molecule
- Upscaling to >100 GBq
- Establishment of CQA and CPP
Formulation and Process Development
- Development of a product formulation to reach target shelf-life of 7 days at room temperature
- Establishment of GMP-compliant excipients sodium acetate, gentisic acid, sodium ascorbate and DTPA
- Establishment of a fully automated GMP-compliant manufacturing process for up to 5 doses per batch based on CPP
QC Methods Development
- Development of analytical methods based on CQA including a dedicated HPLC method being able to separate all radiochemical impurities
Validation Activities
- Validation of process and analytical methods
- Establishment of manufacturing and QC documents
Supply for Clinical Trial
- Weekly supply to different trial centers in the US
Our Expertise in CDMO / CMO Services
At ABX, we continuously advance the development of new radiopharmaceutical solutions – from the initial idea to clinical application. We combine scientific excellence with practical feasibility, turning innovative approaches into market-ready solutions.
