Piramal's Grangemouth, UK facility is USFDA, MHRA & PMDA Japan inspected, offering development, clinical & commercial scale manufacture of bio-conjugates including Antibody Drug Conjugates (ADCs) since 2004.
The site provides full process & analytical development services to support proof-of-concept & Toxicology studies with commercial manufacture of ADCs since 2012.
Specialised capabilities
- Three dedicated GMP production suites for clinical and commercial manufacturing
- Multi-product manufacturing facility characterised by specialised or single-use product-contact manufacturing components
- ISO 7 processing area and ISO 5 filling area
- Site quality management system to ICH Q7
Featured services
- GMP manufacturing of clinical and commercial supplies
- Product commercialisation and scale-up
- Process development, optimisation, and characterisation
- Preclinical and toxicology batch preparations
- Analytical and bio-analytical method development and validation
- Proof of concept studies
- Stability studies and testing
Salient features
- World leader in ADC and bioconjugation process development, GMP manufacture and scale-up
- First CMO to offer contract development and manufacturing service in ADCs
- Worked with >180 unique bioconjugate platforms including all significant ADC drug-linker payloads and numerous proprietary molecules
- Over 450 lab-scale, toxicology and pre-clinical batches in development facility
- Over 500 GMP batches including over 200 commercial lots
- US FDA, UK MHRA, Japan PMDA, Brazil ANVISA, and Turkey Ministry of Health inspected for commercial manufacturing
Location address:
Piramal Healthcare UK Ltd., Piramal Pharma Solutions, Earls Road, Grangemouth, Stirlingshire, Scotland, UK, FK3 8XG
Contact: +44 (0)1324 498300
