Radiolabelling.
GMP-compliant development and quality control of radiopharmaceuticals.
Do you want to efficiently establish the radiolabelling 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.
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.
