High Potent Manufacturing Overview

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 Manufacturing needs. Contact us on +1 215-613-3600 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com

Start your PCI experience today.

Rely on our high potent manufacturing services. Your drug product destination means the world to us.

Awards

We take pride in celebrating the accomplishments and accolades that distinguish PCI Pharma Services, our employees, and our services. These achievements are a testament to our commitment to excellence, innovation, and the unwavering dedication of our teams