High potent Development of Oral Dose Formulations

Development of High Potent Oral Dosage Forms

We provide full pharmaceutical manufacturing and drug development services for both investigational and commercial products including highly potent molecules requiring specialist handling.

With over 35 years of experience of processing potent and non-potent drug products, PCI provides a true partnership and consultative approach from pre-clinical formulation development and API characterization through to full commercial launch.

Specialized Manufacturing of Highly Potent Oral Dosage Forms

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.

In addition, our experienced analytical teams will ensure a successful development program. As a global leader of high potent manufacturing services, a dedicated team will support your product lifecycle with method development, method optimization, method transfer and method qualification/validation.

Our specialist high potent packaging facilities at multiple global locations, complement our development and manufacturing capabilities to provide a seamless solution from the earliest stages of the product lifecycle to commercialization and beyond.

Our dedicated team of specialists will be happy to discuss any of our High Potent Development Services with you. Contact us on +1 215-613-3600 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com