Chemical Synthesis
UK MHRA accredited GMP facility with successful GMP inspections in September 2004, August 2006 and September 2008.
Synthesis route development expertise permits provision of API synthesis from process description on laboratory scale to kilo-scale GMP.
Support for ‘first in man’ clinical studies
GMP synthesis is carried out in a dedicated GMP kilo-scale synthesis facility equipped with:
- 3 x 25 L and 2 x 5 L glass jacketed vessels
- in-process analysis capability
Manufacture of GMP Active Pharmaceutical Ingredients (APIs)
GMP API synthesis is carried out using approved batch documentation and product is released using formally transferred analytical methods. GMP API release is carried out by Quotient QA and a GMP CoA and BSE/TSE certificate are provided.
ICH storage stability studies can be established and supported. Information is provided for incorporation into the submission documentation (relevant sections of the IMPD).
Manufacture of GMP Investigational Medicinal Products (IMPs)
GMP manufacture of solid and liquid dose forms for oral administration (solutions, ‘drug in bottle’, capsules).
The starting point is the production of a trial batch of IMP for assessment of storage stability and for preparation of batch documentation for clinical manufacturing.
ICH storage stability studies can be established and supported. Information is provided for incorporation into the submission documentation (relevant sections of the IMPD).
Clinical manufacturing is carried out using approved batch documentation and the IMP is released using formally transferred analytical methods. A GMP CoA and BSE/TSE certificate is be provided and the IMP can be released by a Quotient Qualified Person (QP)
Custom Synthesis with Stable Isotopes
Quotient Bioresearch has a great deal of experience in the preparation of stable-labelled compounds for use as internal standards in bioanalysis. Stable isotope custom synthesis is carried out using C-13, H-2 and N-15 and the fitness for purpose of our prepared internal standards can be demonstrated by test analysis runs using Quotient’s wide range of LC-MS/MS bioanalytical equipment.
Release analysis is carried out in our GMP-compliant analytical laboratory and a full CoA/Compound Data Sheet is provided.
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; ICH - International Conference on Harmonization; LC-MS - Liquid Chromatography-Mass Spectrometry.