High potent Development of Sterile and Oral Dose Formulations
Development of High Potent Oral and Sterile Dosage Forms
We provide full pharmaceutical manufacturing and drug development services for both investigational and commercial products including highly potent molecules requiring specialist handling.
With over 35 years of experience of processing potent and non-potent drug products, PCI provides a true partnership and consultative approach from pre-clinical formulation development and API characterization through to full commercial launch.
Sterile injectables
Tablets, capsules and powders
Gels and creams
Liquids, solutions, suspensions and emulsions
Suppositories and pessaries
Granules for reconstitution
Drug in capsule/vial
Specialized Manufacturing of Highly Potent Oral Dosage Forms
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
Development to commercial scale manufacturing and packaging
Segregated people and material flow
Secure access with client viewing gallery
Automated cleaning procedures
Purpose-built, high performance, bespoke effluent treatment facility
HVAC system with single pass air
Contained engineering eliminating the need for personal protective equipment (PPE)
Meeting regulatory standard for major markets including Japan, TMoH, the MHRA, FDA and ANVISA.
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
