Radiolabeling Development
and Radiosynthesis.
GMP-compliant development and quality control of radiopharmaceuticals.
Do you want to efficiently establish the radiolabeling development of your precursors – and reliably prove the quality of your final products? Even minor deviations in labelling or formulation impact stability, efficacy, and patient safety – and put your project at risk.
To ensure seamless quality and safety, we offer radiolabelling development combined with chemical analytics (radio-TLC, (radio-)HPLC-MS, ICP-MS) and microbiological testing. We determine radiochemical purity (RCP) and yield (RCY), identify by-products, and assess stability and sterility in full compliance with Ph. Eur. standards. This integrated workflow shortens timelines, simplifies processes, and accelerates your path to success.
GMP Radiolabeling Development.
From First Discussion to Method Transfer.
Radiolabeling is a critical step in radiopharmaceutical development – and often a source of variability, delays and regulatory risk.
In our upcoming webinar, we share a practical, real-world perspective on how radiolabeling can be translated into robust analytical methods, validated under GMP conditions and successfully transferred into routine quality control.
With insights from CUP Contract Labs and an industry perspective from CMC development, the session highlights what it takes to ensure reliable development, transfer and manufacturing.
📅 April 21 | ⏱ 15:00 CET | 💻 Online
Our Services:
- Radiolabelling: Optimisation of labelling conditions and formulation for small molecules, peptides, and antibodies with all common radionuclides incl. complete documentation.
- Analytics & Quality Control: Identity/purity via radio-TLC and radio-LC-MS. LC-MS and ICP-MS for identification and quantification of impurities and trace metals, GC/MS and IC to detect residual solvents and other critical impurities (e.g., TFA). All methods are fully validated, delivering results suitable for audits and regulatory submissions.
- Microbiology & Release: Sterility and bacterial endotoxin analyses performed according to Ph. Eur. 2.6.1 / 2.6.14. No shipping, samples are directly tested – rapid release, essential for radiopharmaceuticals with short half-lives.
Every step of development, production, and testing is documented in full compliance with GMP, supporting your inspections (e.g., EMA/FDA) and giving you planning security for your dossier. With our expertise and integrated approach, we lay the foundation for safe and fully compliant radiopharmaceuticals – giving you the confidence that your processes meet the highest pharmaceutical standards.
expert voices
I am fascinated by radiolabelling because it combines radiochemistry and state-of-the-art analytics. I can see the results immediately, optimise methods and thus ensure that our radiopharmaceutical products meet the highest quality standards right from the start – for the protection of patients.
