Integration
A seamless, end-to-end approach that connects development, manufacturing, analytical, and packaging services to reduce complexity, risk, and handoffs across the product lifecycle.
High-Potent Clinical Trial Manufacturing
Our strength lies in integrating formulation and analytical development with GMP clinical manufacturing and packaging, guided by experienced cross-functional teams to ensure efficiency, quality, and seamless execution.
Across the lifecycle
With over 35 years of high potent processing experience, we deliver fully integrated clinical manufacturing services across the entire product lifecycle, supporting a broad range of dosage forms in full compliance with global GMP standards.
Manufacturing with confidence
Our facilities support both solid oral dose forms and oral liquid products, providing flexibility across a wide range of development and manufacturing needs. All services are backed by a dedicated team of Qualified Persons (QPs), a fully equipped analytical laboratory, and a GMP-compliant warehouse, ensuring quality, efficiency, and regulatory compliance at every stage of the process.
Contained. Integrated. Proven.
With more than 35 years of expertise in potent processing, we safely handle compounds with Occupational Exposure Limits (OELs) as low as 0.01 µg/m³. Our advanced containment technologies support the safe development, clinical supply, and commercial production of high-potency drug products within our purpose-built, high-containment facility featuring:
- End-to-end manufacturing and packaging from development to commercial scale
- Multiple compound processing capabilities
- Common equipment trains ensure seamless scale-up and reproducibility
- Segregated personnel and material flows for enhanced safety
- Automated cleaning and contained engineering eliminate reliance on PPE
- Single-pass HVAC and high-performance effluent treatment
- Client viewing gallery and secure access controls
- Compliant with global regulatory standards: FDA, MHRA, ANVISA, Japan, TMoH
Our experienced analytical teams play a critical role in ensuring the success of every development program through comprehensive method development and optimization, method transfer, and method qualification and validation. These services are fully integrated with our manufacturing operations, enabling seamless data continuity, streamlined processes, and complete regulatory confidence.
High-potency packaging
With specialized high-potency packaging facilities located across our global network, we provide a seamless transition from early-stage development through commercialization. Our integrated approach connects manufacturing and packaging under one framework, ensuring efficiency, quality, and speed-to-market. With a worldwide footprint, we maintain compliance with regional regulatory requirements, supporting reliable supply and market readiness.
Containment technology
We’ve enhanced our microdosing platform with advanced containment technologies, Xcelohood™ and Xceloprotect™, designed to ensure the highest levels of operator safety and product integrity. These systems provide controlled environments for the precise handling and dosing of highly potent compounds, reinforcing containment standards throughout development and manufacturing.
Xcelodose® microdosing
A faster, simpler path to First-in-Human (FIH) studies. Our microdosing technology, Xcelodose®, enables precise, contained dosing of both potent and non-potent drug substances directly into capsules or vials. This approach removes the need for early formulation development and significantly reduces time-to-clinic.
- Programmable microdosing (100µg to 100mg+)
- Capsule filling with drug substance
- No powder blend required
- Supports moisture-sensitive compounds
- Fills a range of container types
- Full traceability and GMP-compliant
- Optimized method development
- Improved data transfer
We are inspired by tomorrow
Compliance
Operations and systems designed to meet the requirements of major global health authorities, supporting confident submissions and approvals across international markets.
Velocity
Demonstrated experience advancing programs efficiently through development, clinical supply, and commercialization while maintaining quality and compliance.
Precision
Advanced engineered containment and precision dosing capabilities that enable the safe handling, development, and manufacture of highly potent compounds.
Non-Sterile Development & Manufacturing
World-leading science and minds supporting process development, formulation, and optimization on the pathway connecting your product to patients
Learn more about our non-sterile capabilities and how we deliver safe, reliable, and scalable solutions across a broad range of oral dosage forms.
Contact us today to talk to our expert customer services team about how we can support you with high potent clinical manufacturing services.