cGMP

cgmpPepceuticals offers a versatile cGMP service to support research and in-process projects from pre-clinical toxicology studies through to early stage clinical trials.  We help our customers reduce the discovery-to-market timeline by providing development to medium-scale manufacturing at one facility.  We provide CMO and CMR services for the manufacture of active substances including peptides.

  • Pre-GMP process development and process transfer
  • Re-processing or finishing of existing materials (sterile fill)
  • Preparation of reference standards
  • Analytical method development and validation
  • API manufacture
  • Stability testing
  • Process validation
  • Support with regulatory documentation

Our facility which is based in Leicestershire (UK), houses over 10,000 square feet of modern laboratories which incorporates eight cGMP suites.  The facility has been designed and built to meet national and international standards (EC guidance for GMP, Eudralex Vol. 4, Part I, II and Annex 1; ICH Q7A; US Federal Standard 209 E; and the ISO classification) required for API manufacture.

Designed specifically for versatility, the access-controlled facility operates at a minimum of Grade C (Class 10,000; M 5.5; ISO 7), encompassing Grade B laboratories incorporating a laminar flow Grade A (Class 100; M 3.5; ISO 5) cabinet.  Offering a selection of large and medium sized cGMP laboratories equipped with built-in fume cupboards and walk-in fume cupboards, our state-of-the-art facility and highly trained scientists ensure that your project requirements are exceeded.