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 firstname.lastname@example.org
Our development & manufacturing services
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