High Potent Clinical Trial Manufacturing

PCI provides a comprehensive service at each stage of the product lifecycle for a wide range of dosage forms, in full compliance with GMP regulatory standards for both highly potent and non-potent drug products.

Our strength lies in the integrated nature of our services, combining formulation and analytical development with GMP clinical manufacturing and packaging through a full cross-functional project team, coordinated by an experienced team of project managers.

Utilizing our state-of-the-art facilities, we offer unrivalled capabilities and a true focus on customer need. We provide clinical manufacturing of multiple dosage forms for investigational use including solid oral dose, liquids, semi-solids and aseptic fill finish processing.

All clinical manufacturing services are fully supported by a dedicated and experienced team of Qualified Persons, a full analytical laboratory and a GMP compliant warehouse.

Specialized Manufacturing of Highly Potent Products

Building on 35 years in potent processing, we offer a purpose-built facility utilizing the very latest in containment technology, enabling the safe development, clinical and commercial supply of products with an occupational exposure limit (OEL) as low as 0.01µg/m3.

The facility itself has multiple levels of containment built into the design. Dispensing of API is undertaken within isolators and subsequent processes within appropriately contained equipment, ensuring operator safety and preventing cross-contamination.

Our fully integrated facility utilizes common equipment trains from development to commercial scale, with geometric scale-up delivering reproducibility and ultimately speed-to-market.

  • Multiple compound processing
  • Development to commercial scale manufacturing and packaging
  • Segregated people and material flow
  • Secure access with client viewing gallery
  • Automated cleaning procedures
  • Contained engineering eliminating the need for personal protective equipment (PPE)
  • HVAC system with single pass air
  • Purpose-built, high performance, bespoke effluent treatment facility
  • Design-for-manufacture delivering true speed-to-market
  • Meeting regulatory standards for major markets including Japan, TMoH, the MHRA, FDA and ANVISA

    Our dedicated team of specialists will be happy to discuss any of your High Potent Clinical Manufacturing needs. Contact us on +1 779-208-1819 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com

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