GMP Radiosynthesis
UK MHRA accredited GMP facility with successful GMP inspections in September 2004, August 2006 and September 2008
Manufacture of [14C] APIs for Clinical Use
The starting point is the production of a trial batch of C-14 labelled API:
- for assessment of [14C]API storage stability
- for use in pre-clinical dosimetry studies
- for use in trial C-14 labelled IMP manufacture and associated storage stability studies.
The trial radiosynthesis also provides information:
- for preparation of batch documentation for the clinical radiosynthesis
- for incorporation into the submission documentation (relevant sections of the IMPD)
Clinical radiosynthesis is carried out using approved batch documentation and the clinical [14C]API is released using formally transferred analytical methods. A GMP CoA and BSE/TSE certificate can be provided.
Manufacture of [14C] IMP
GMP manufacture of radiolabelled solid and liquid dose forms for oral administration (solutions, ‘drug in bottle’, capsules) and radiolabelled solutions for iv administration (in collaboration with Quotient Clinical).
The starting point is the production of a trial batch of C-14 labelled IMP for assessment of [14C]IMP storage stability and for preparation of batch documentation for clinical manufacturing. Information is provided to support any regulatory submissions including information required for relevant sections of the IMPD.
Clinical manufacturing is carried out using approved batch documentation and the [14C]IMP is released using formally transferred analytical methods. A GMP CoA and BSE/TSE certificate is be provided and the [14C]IMP can be released by a Quotient Qualified Person (QP)
Contact us for more information or to discuss your specific needs
MHRA - Medicines and Healthcare products Regulatory Agency; GMP - Good Manufacturing Practice; API - Active Pharmaceutical Ingredient; IMP - Investigational Medicinal Product; IMPD - Investigational Medicinal Product Dossier; BSE - Bovine Spongiform Encephalopathy; TSE - Transmissible Spongiform Encephalopathy.