Oral Targeted Modalities and Solubility Enhancement
Flexible, integrated solutions for highly potent oral targeted therapies
At PCI, we combine deep expertise in highly potent API (HPAPI) development with access to advanced solubility technologies – offering fully integrated, flexible solutions for your targeted oral therapies.
We support the development and manufacturing of oral targeted therapies through a flexible model. With deep expertise in the processing of highly potent molecules built over 35 years and through a trusted partner network, we act as your single point of contact across the full CDMO journey.
We take an pure approach to development; we build the process around your product and not our setup. Throughout our 35 years of developing and manufacturing highly potent products, we have supported a wide range of oral drug products classified as being highly potent, and through this experience and expertise, we are able to support almost any project.
We understand that solubility can present major challenges with some modalities, and we are able to bring proven strategic development options. Our network includes renowned specialists in spray drying, hot melt extrusion (HME), and solubility enhancement solutions, which are fully integrated with our development strategies. Our in-house subject matter experts are here to support you at every step of the process and identify the potential development pathways for your drug product. At PCI, we act as the conduit for all development work, acting as your single point of contact throughout the development process.
With over 35 years of experience in the processing of highly potent drug products, our infrastructure and processes are designed to achieve the highest standards in operator safety and drug product integrity.
Purpose-built, world-class containment suites utilizing contained engineering and isolator technology
Development and manufacturing solutions for highly potent APIs with OELs as low as 0.01µg/m³
Geometric scale-up supporting programs from early-stage formulation through commercial launch
Experienced cross-functional teams with specialized knowledge of HPAPI processing
Specialist high potent packaging solutions across the product lifecycle
A high proportion of drug candidates encounter solubility issues. For highly potent therapies, this can create additional complexity. With our internal expertise and through our strategic network of world leading partners, PCI offers integrated access to advanced solubility enhancement technologies including:
Micronization
Spray Drying
Hot Melt Extrusion
Nano Technology
Our molecule-first development model means we identify and deploy the right techniques based on your molecule’s characteristics.
PCI acts as the single point of contact across all development and manufacturing activities, streamlining your program from start to finish. Our development services include:
Collaborative early-phase formulation support
SME access for real-time, science-led decision making
Integration with external specialist service providers, coordinated and managed by PCI
Scale-up, technical transfer, and commercial readiness managed across our global network
In-house packaging solutions
Regulatory and safety compliance at every stage
Our clients rely on PCI not just for what we do, but for our collaborative approach and end-to-end program management.
Oral targeted therapies are increasingly preferred for their patient convenience and precise therapeutic mechanisms.
Many oral targeted therapies come with unique challenges and require specialist services to enhance bioavailability.
PCI does not force-fit molecules into fixed platforms; we design the right development pathway for each unique product
Our “agnostic” approach means we select technologies and workflows around the molecule, not our existing setup
As the oral targeted therapies market grows, flexibility, agility, and customization are key to program success
PCI offers decades of experience handling highly potent APIs (HPAPIs), with dedicated containment suites and isolator technology.
>35 years’ high potent experience
Engineered containment solutions
OEL down to 0.01 µg/m³
Facilities support both development and commercial-scale manufacture.
Experience with TPD/Molecular Glues
Oncology, neurology, autoimmune
PCI addresses solubility challenges early, leveraging advanced formulation and process techniques.
Technologies including spray drying and hot melt extrusion are part of our integrated toolkit to enhance oral bioavailability for even the most challenging molecules
Through trusted partners, PCI offers seamless access to:
Spray Drying
Solubility Enhancement
Hot Melt Extrusion
Strategic integration ensures no project hand-offs or delays, and a fully coordinated solution from preclinical through commercialization
PCI clients engage directly with formulation, analytical, and process development SMEs for immediate, science-driven support driving program efficiency and speed to clinic
This hands-on approach accelerates problem-solving and supports informed decision-making at every development stage
PCI acts as your single point of contact, coordinating all CDMO activities from development through to commercial launch
This centralized model simplifies communication, aligns goals, and ensures continuity across all phases of your program
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
