Selcia is certified by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the preparation and C-14 labelling of active pharmaceutical ingredients (API) for clinical trials.
Selcia can prepare C-14 radiolabelled API for Phase I, mass balance and microdosing (phase 0 and enhanced Phase I) studies.
Whether you require a synthesis or repurification under GMP, we perform both in compliance with EMEA and the recent FDA Phase I GMP guidance (IQCH Q7A Section 19: Single batches for investigational drugs). We are certified by the UK's MHRA for preparation and 14C labelling of APIs for clinical trials.
The radiolabelled API is analysed in Selcia’s GLP certified analytical laboratory and supplied with a complete analytical data package.
The 14C radiolabelled API can be sent to the contract research laboratory (CRO), which carries out the GMP manufacturing step to prepare the investigational medicinal product (IMP). Alternatively Selcia can work with a partner company that is able to prepare oral or sterile I.V. doses in its GMP facility.
GMP work is carried out in our state-of-the-art facilities, which include two recently commissioned radiosynthesis laboratories.
The API is analysed in a GLP analytical facility
- 400MHz and 500MHz NMR for residual solvent determination
Some features of our GMP work include:
- Quarantine and identity testing of raw materials
- Production area clean down verification
- Accurate recording of experimental procedures and witnessing of critical processes
- Rigorous analytical procedures to establish product identity and quality
- Radiochemical stability data
- Quarantine and release of API by our internal QA to the QP
Please contact us for more information and we will be pleased to discuss your GMP radiolabelling project with you.
Audits of our facilities are always welcome