Oral Targeted Therapies: The Next Generation.

As a world class CDMO, we relentlessly strive to deliver oral targeted therapies and better health outcomes for the patients we serve by combining our experience and expertise in science, manufacturing, and technology with our pristine customer service.

Oral Targeted Therapies: The Next Generation: Explore how PCI supports targeted protein degraders (TPDs)—solving solubility, scalability, and stability challenges in this emerging oral drug class.

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.

Oral Targeted Therapies: The Next Generation. The oral targeted therapies market is projected to grow at a CAGR exceeding 20% over the next five years.

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.

Oral Targeted Therapies: The Next Generation. The Solution.

High potent containment down to 10ng/m3 (OEB5) – we are experts in handling highly potent molecules.

Oral Targeted Therapies: The Next Generation. The Solution.

On-site high potent packaging facility and analytical development and testing, creating an integrated single-site solution.

Oral Targeted Therapies: The Next Generation. The Solution.

Hundreds of molecules supported, from clinical to commercial scale.

Oral Targeted Therapies: The Next Generation. The Solution.

Exemplary regulatory history – FDA, MHRA, EMA, ANVISA and more.

Integrated Access to Enabling Technologies

Oral Targeted Therapies: The Next Generation. 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.

Oral Targeted Therapies: The Next Generation. Integrated Access to Enabling Technologies

Customers have direct access to OSD experts, for immediate, science-driven support: a hands-on approach which accelerates problem-solving.

Oral Targeted Therapies: The Next Generation. Integrated Access to Enabling Technologies

A strategic integration means no project hand-offs or delays, with PCI experts working alongside partnership expertise as a consolidated service offering.

Oral Targeted Therapies: The Next Generation. Integrated Access to Enabling Technologies

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.

Oral Targeted Therapies: The Next Generation. SmartFHD Development Team
Oral Targeted Therapies: The Next Generation. The process.

We are committed to supporting clients with the development of oral targeted therapies, delivering best-in-class services efficiently and effectively. Discover more about the next generation of oral targeted therapies here.

Learn more about our fully integrated targeted therapy services here.


Our dedicated team of specialists will be happy to discuss any of your Contract Development needs. Contact us on +1 215-613-3600 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com

Let’s Accelerate Your Success

Partner with PCI today to break barriers, reduce timelines, and deliver your life changing therapies to patients faster.

talkfuture@pci.com

Always growing and continually advancing, we support you from early-stage development through commercialization and beyond, and with 7500+ people in 30 global GMP facilities, we are always near.

Awards

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