As a world class CDMO, we relentlessly strive to deliver better health outcomes for the patients we serve by combining our experience and expertise in science, manufacturing, and technology with our pristine customer service.
Our Philosophy: Product first approach, High Potent handling, Agnostic enabling technology selection, Developability assessment, SMART First Human Dose, Full range of integrated downstream Clinical and Commercial Manufacturing and Packaging services.
PCI Pharma Services has over 35 years of experience in the development and manufacture of highly potent oral solid dosage forms. By partnering with industry-leading innovators, PCI can solve the unique challenges of poorly soluble molecules like targeted protein degraders (TPDs), such as PROTACs and molecular glues, seamlessly accelerating your molecule from development to commercialization.
The Market
The oral targeted therapies market is projected to grow at a CAGR exceeding 20% over the next five years. Program success will be determined by a CDMO’s flexibility, agility, and customization capabilities.
The Challenge
70-80% of new small molecule candidates are classified as poorly soluble, requiring some form of solubility enhancement technology.
Targeted therapies require low-dose precision, demanding advanced formulation strategies and high potent containment solutions.
HPAPIs are increasingly common in targeted therapy pipelines.
The Solution
PCI’s product-first, platform-agnostic approach means we can select the best enabling technologies and workflows around the specific needs of your molecule. Our 35 years’ experience in high potent OSD processing, and our expanded network of strategic development partners, enables us to meet your OSD development program needs.
High potent containment down to 10ng/m3 (OEB5) – we are experts in handling highly potent molecules.
On-site high potent packaging facility and analytical development and testing, creating an integrated single-site solution.
Hundreds of molecules supported, from clinical to commercial scale.
Exemplary regulatory history – FDA, MHRA, EMA, ANVISA and more.
Integrated Access to Enabling Technologies
PCI’s trusted partners network offers seamless access to Micronization, Spray Drying, Hot Melt Extrusion, and Nano-technology, with PCI acting as the Single Point of Contact to find the right solution for your product.
Customers have direct access to OSD experts, for immediate, science-driven support: a hands-on approach which accelerates problem-solving.
A strategic integration means no project hand-offs or delays, with PCI experts working alongside partnership expertise as a consolidated service offering.
This results in a fully coordinated development solution, with the ability to work in a phase-appropriate manner and scale the selected technology from preclinical to commercialization.
SmartFHD
SmartFHD (First Human Dose) is a rapid development, manufacturing and clinical packaging process, resulting in superior speed to clinic for First in Human / Phase I clinical trials. The SmartFHD team consists of cross-functional experts, with extensive industry experience, using technologies such as Xcelodose® for accurate microdosing. Our global presence in Australia, Asia, the US and Europe provides an agile clinical distribution network.
With no potency limitations, flexible global clinical support, proactive project management and a dedicated Smart CMC team, we can deliver your drug product to clinic in as little as four months.
Let’s Accelerate Your Success
Partner with PCI today to break barriers, reduce timelines, and deliver your life changing therapies to patients faster.
