PCI provides a comprehensive service at each stage of the product lifecycle for a wide range of dosage forms, in full compliance with GMP regulatory standards for both highly potent and non potent drug products.
Our strength lies in the integrated nature of our services, combining formulation and analytical development with GMP clinical manufacturing and packaging through a full cross functional project team, coordinated by an experienced team of project managers.
Utilizing our state-of-the-art facilities, we offer unrivaled capabilities with a focus on customer needs. We provide clinical manufacturing of multiple dosage forms for investigational use including solid oral dose, liquids, semi-solids, and aseptic fill finish processing.
All clinical manufacturing services are fully supported by a dedicated and experienced team of Qualified Persons, a full analytical laboratory, and a GMP-compliant warehouse.
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
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
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.
High Potent Microdosing Technology, Xcelodose®
Delivering drug directly into capsules or vials using contained microdosing technology removes the need for initial formulation development and associated stability, leading to faster first-in-man studies and cost efficiencies.
The fully programmable system ensures exceptional levels of accuracy and precision whilst minimizing wastage of drug substance. We are proud to offer multiple options of microdosing technology, delivering individual client volume requirements.
PCI has further invested in Xcelohood™ and Xceloprotect™ technology for microdosing technologies, further enhancing our contained solutions for the development and manufacturing of highly potent drug products.
Features of Xcelodose® Technology
Programmable and precise dispensing of dose weights from 100 micrograms to 100 milligrams and beyond
Weight of each capsule content is recorded, allowing traceability of samples that meet GMP requirements
Simplifies analytical development and stability requirements, reducing development time
Reduces waste and eliminates the need for a “powder blend”
Ability to handle moisture-sensitive compounds
System is able to fill capsules and a variety of small dose containers including; vials, tubes, blisters and cassettes
Precision closing of capsules
Compensates for variability in drug powder properties
Simplification of method development
Improved data transfer
Can be used for formulation development, pre-clinical and clinical trial batch manufacturing for both potent and non-potent molecules
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
