High Potent Commercial Manufacturing

PCI offers flexible and globally compliant commercial scale manufacturing and packaging of multiple dosage forms including tablets, capsules, creams, gels, ointments, and oral liquids for both highly potent and non-potent drug products.

Investments include separate suites for large-volume tablet and liquid manufacture as well as specialist roller compaction technology for heat and moisture-sensitive formulations.

A dedicated department of validation specialists ensure a seamless transition from clinical phase to commercial launch as well as supporting ongoing commercial supply through continuous process verification (CPV).

Commercial manufacturing and packaging is supported by an experienced team of Qualified Persons, a full analytical release testing laboratory and a GMP-compliant temperature-controlled warehouse with storage down to -20°C.

Commercial Manufacturing Operations include:

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 Commercial Manufacturing needs. Contact us on +1 779-208-1819 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com

Talk to us about our world leading high potent commercial manufacturing services today.

talkfuture@pci.com

Always growing and continually advancing, we support you from early-stage development through commercialization and beyond, and with 6000+ people in 30 global GMP facilities, we are always near.