PCI provides full development and manufacturing services for both investigational and commercial products, including highly potent molecules requiring specialist handling.
With over 35 years of experience in processing potent and non-potent drug products, PCI provides a partnership and consultative approach from pre-clinical formulation development and API characterization through to full commercial launch.
When it comes to caring for humanity, ensuring life changing medicines reach those who need it most is our highest priority. As manufacturing and supply chain experts, we use our experience and expertise to navigate every challenge we may face on behalf of our clients with the ultimate aim of improving lives.
We are able to provide manufacturing services at clinical and commercial scale for both potent and non-potent drug products and multiple dosage forms including solid oral dose tablets and capsules, semi-solid creams and ointments, and non-sterile oral liquids. We also provide extensive packaging capabilities at clinical and commercial scale including Serialization.
We are able to offer formulation development services for a variety of dosage forms including:
Tablets, capsules, and powders
Gels and creams
Liquids, solutions, suspensions, and emulsions
Suppositories and pessaries
Drug-in-Capsule/vial
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.
Multiple compound processing
Clinical to commercial scale high potent manufacturing; 1kg to 150kg batch sizes
Processing of OEL down to 0.01µg/m3
Segregated people and material flow
Secure access with client viewing gallery
Automated cleaning procedures
Contained engineering eliminating the need for personal protective equipment (PPE)
HVAC system with single-pass air
Purpose-built, high performance, bespoke effluent treatment facility
Meeting regulatory standards for major markets including Japan, TMoH, the MHRA, FDA and ANVISA
High potent packaging facility for the primary and secondary packaging of highly potent actives including bottle and blister formats and Serialization providing end-to-end solutions
