High Potency Services

NPIL Pharma is an established custom manufacturing organization in the area of High Potency Actives. Our Grangemouth site (Scotland, UK) routinely manufactures a wide range of oncology products and we are a world leader in the area of antibody-drug conjugation manufacture

The Grangemouth site has 5 completely segregated suites operating under OEB 4/5 containment levels. Within the small molecules category, NPIL has dedicated suites for manufacturing cytotoxics and cytostatics (including cell cycle inhibitors) supported by a strong process development team. In the area of antibody-drug conjugates, NPIL has worked on all leading technology platforms and has the requisite R&D; and analytical capability to support the development and testing of biologics (click here for summary of capabilities in conjugation services)

The site QA system was audited by the USFDA (Pre-approval Inspection for veterinary product) in 2006 without any 483s and has been regularly audited by the UK MHRA

A detailed description of the manufacturing suites and the scale of operations is presented in the links below:

  • Suite 1 : dedicated for commercial manufacture of high potency veterinary prostaglandin
  • Suite 2 : utilized for manufacture of cytotoxic small molecules and conjugates, also equipped with bulk lyophilisation capability
  • Suite 3 : suite available for manufacture of non-cytotoxic high potency actives upto 2 Kg batch sizes
  • Suite 4 : suite can be upgraded for manufacturing high potency actives (cytotoxic or non-cytotoxic) of upto 5 Kg batch sizes
  • Suite 5 : recently upgraded suite for manufacture of small molecules and conjugates

NPIL Pharma is at an advanced stage of upgrading its assets in UK to manufacture larger scale High Potency Actives (upto 20 Kgs batch sizes) under OEB 3 / 4 containment. Current plans are to upgrade suites at our Huddersfield/Morpeth sites within a time frame of 6-8 months – this would enable NPIL to supply Phase III to launch drug requirements

High Potency ServicesHigh Potency Services