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Grangemouth, UK

Grangemouth, UK is a USFDA and MHRA approved site dedicated to the contract development and manufacturing of Antibody Drug Conjugates since 2004. It is the first ever to offer CMO services in the field of ADC.  With over 10 years of extensive experience in this field, the site covers all major ADC drug classes and linker chemistries.

Services Offered:

  • Process development, optimisation and characterisation
  • Preclinical and toxicology batch preparations
  • GMP manufacture of clinical and commercial supplies
  • Analytical and bio-analytical method development and validation
  • Proof of Concept studies

Site Capabilities:

  • Multi-Product manufacturing facility characterised by dedicated or single use product-contact manufacturing components
  • 5-200 L Project dedicated vessels (glass)
  • Capability to manufacture Batch size ranging from 1 – 2kgs
  • ISO 7 processing area & ISO 5 filling area
  • Containment category 4 (Safe bridge)
  • Site Quality Management System to ICH Q7
  • Bio-safety cabinet for safe handling of cytotoxic materials

Salient Features:

  • First to offer Contract development and Manufacturing service in ADCs ever
  • US FDA and MHRA approved CMO for commercial Manufacturing of ADCs
  • World leader in ADC process development, GMP manufacture & scale-up
  • Experience of over a decade of working with multiple (over 100) ADC platforms
  • Manufactured over 460 batches (>270 GMP batches) of phase III/commercial ADC, in addition to several other lab scale, toxicology and GMP phase I/II batches
  • Experience of working with several cytotoxins, including auristatins, maytansines, and duocarmycin

Contact Details

Piramal Healthcare UK Ltd.
Piramal Pharma Solutions
Earls Road, Grangemouth
Stirlingshire, FK 38XG
Scotland, UK

For more information about our ADC Services click here