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.

Specialized Manufacturing of Highly Potent Sterile Products Including ADCs

Antibody-drug conjugates

Antibody-drug conjugates (ADCs) are transforming oncology treatment and at PCI, we believe that selecting the right CDMO for your new ADC is as important as selecting the right ADC components. As a partner, we offer stability, quality, strategic alignment and a forward-thinking approach in the development and manufacturing of your ADC product, supported by full, temperature-controlled packaging, storage and distribution services from our clinical packaging sites globally.

The components required for the successful development of ADCs include Sterile fill-finish, lyophilization and specialist high-potency processing capabilities.

At PCI, our Integrated ADC Development Services include:

• Development, optimization and manufacturing services
• Process development, process optimization and scale up
• Formulation development (liquid and lyophilized) and drug product development
• Regulatory support

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

To complete our end-to-end service offering and driven by innovation and patient-centricity, our packaging design and development expertise, drug device final assembly, pack and test, and advanced drug delivery packaging capabilities offer flexible solutions for a diverse portfolio of conventional and specialty injectable drug products.

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