Spotlight on Piramal Pharma Solutions, Scotland

Published: 23-Jun-2021

Taking a closer look at the company's facility in Grangemouth

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

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