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.

 

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

Start your PCI experience today.

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

A world of development and manufacturing awaits

As pharmaceutical manufacturing and supply chain experts, we use our experience, expertise, and manufacturing innovation to navigate every challenge we may face on behalf of our clients with the ultimate aim of improving patients' lives.

talkfuture@pci.com

Spanning the cycle. A truly global proposition.

Always growing, we are driving development and connecting commercialization, and with 4300 people in 30 global GMP facilities, we are always close.