Integration
A seamless, end-to-end approach that connects development, manufacturing, and scale-up activities to reduce complexity, risk, and handoffs across the product lifecycle.
High Potent Drug Development
With over 35 years of expertise in potent and non-potent oral dosage forms, we support programs from preclinical development and API characterization through commercial launch.
Built for complexity
We provide comprehensive pharmaceutical development and manufacturing solutions for both clinical and commercial products, including highly potent compounds that require specialized handling.
Where containment meets scale
Enabling the safe and compliant development, clinical supply, and commercial manufacturing of highly-potent oral products, with occupational exposure limits (OELs) as low as 0.01 µg/m³, our purpose-built high containment facilities feature:
- Multi-level containment built into facility design
- Isolator-based API dispensing and contained processing equipment
- Integrated development-to-commercial equipment trains for seamless scale-up
- Reproducible processes designed for speed-to-market
We provide a fully contained, end-to-end manufacturing environment designed for safety, efficiency, and regulatory compliance. Our facilities support development through to commercial-scale manufacturing and packaging, with the capability to process multiple compounds simultaneously.
The layout includes segregated personnel and material flows, client viewing galleries with secure access, and automated clean-in-place (CIP) systems for optimal hygiene and containment. Additional features include custom effluent treatment facilities, a single-pass air HVAC system, and a contained engineering environment that minimizes the need for personal protective equipment. All operations meet global regulatory standards, including FDA, MHRA, TMoH, ANVISA, and Japan.
Core capabilities
We support a wide range of dosage forms, including tablets, capsules, and powders, as well as liquids and granules for reconstitution. Our expertise also extends to drug-in-capsule and vial presentations. With a flexible, science-driven approach, we design formulation strategies that align with each molecule's characteristics and project goals.
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.
We are inspired by tomorrow
Velocity
Demonstrated experience advancing programs efficiently through development and into clinical and commercial supply, without compromising quality or compliance.
Trust
Long-standing partnerships with leading pharmaceutical and biotechnology organizations, built on consistent performance, technical expertise, and reliable delivery.
Compliance
Operations designed to meet the requirements of global regulatory authorities, supporting confident submissions and approvals across key international markets.
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 drug development services.