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 sterile injectables, 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:
Sterile injectables
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
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.
We take pride in celebrating the accomplishments and accolades that distinguish PCI Pharma Services, our employees, and our services. These achievements are a testament to our commitment to excellence, innovation, and the unwavering dedication of our teams
