High-Potent Commercial Manufacturing
Whether you’re scaling up a new product or transferring an existing one, we bring the expertise, infrastructure, and global reach to support success at every stage of the product lifecycle.
Built for commercial scale
We provide end-to-end commercial-scale manufacturing and packaging solutions for a wide range of dosage forms. With decades of experience, we deliver efficient, high-quality, and compliant services that support each product's journey from clinical transition through full commercialization.
Capability meets capacity
We manufacture and package both potent and non-potent drug products across multiple formats, including tablets, capsules, and oral liquids. Our facilities are designed to support large-scale production with flexible batch sizes, advanced equipment, and full regulatory compliance across global markets.
We've made strategic investments to ensure speed, safety, and scalability across our operations. Our facilities include dedicated high-volume suites for tablets, capsules, and liquids, supported by specialist roller compaction technology designed for moisture and heat-sensitive APIs. Geometric scale-up ensures reproducibility from clinical to commercial scale.
We maintain GMP-compliant, temperature-controlled warehouses with storage capabilities down to -20°C, alongside full-service analytical release testing laboratories. Our experienced Qualified Persons (QPs) and validation teams oversee every stage of production, while continuous process verification (CPV) ensures a seamless transition from clinical manufacturing through to commercial supply.
Dispensing & Granulation
Our dispensing operations feature multiple on-site suites equipped with high-performance isolators for the safe, precise handling of highly potent APIs, ensuring efficiency, containment, and product integrity throughout the process. Our granulation capabilities support batch sizes from 10 L to 600 L, utilizing high-shear mixer granulators, fluid bed dryers, and roller compaction technology for the precise processing of both standard and sensitive formulations.
Tablet Compression & Capsule Filling
Our high-speed tablet compression equipment produces up to 200,000 tablets per hour, supporting both simple and complex shapes. Instrumented presses enable precise data capture and validation, ensuring consistency, quality, and efficiency throughout production. Our capsule-filling capabilities support a range of output speeds and capsule sizes for modified-release, multiparticulate, inhalation, and moisture-sensitive formulations. Online and offline weight checks maintain consistent quality and compliance throughout.
Tablet Coating & Semi-Solid & Oral Liquids
Our tablet coating capabilities include aqueous film coating systems and perforated pan coaters for a range of batch sizes. Clean-in-place (CIP) systems and contained setups enable safe, efficient processing of potent actives while maintaining high-quality standards. We deliver high-performance processing with vacuum, heating, and in-line homogenization technologies, supporting both tube and bottle filling at commercial scale. In-house analytical and microbiology laboratories provide full support to ensure quality and compliance.
High Potency. High Precision.
Supporting the safe and efficient development and commercial supply of products with an occupational exposure limit (OEL) as low as 0.01µg/m³, our dedicated high containment facility features:
- Full development-to-commercial scale capability
- Multi-level containment systems
- Isolator-based dispensing and contained equipment
- Automated CIP procedures
- HVAC with single-pass air systems
- Bespoke effluent treatment
- Regulatory compliance with FDA, MHRA, ANVISA, TMoH, and Japan
Our dedicated analytical teams support every stage of development and commercialization through comprehensive method development and optimization, method transfer and validation, and ongoing analytical support across the entire product lifecycle.
High-potency packaging network
Our specialized packaging facilities complement our manufacturing expertise, providing contained, compliant environments across global locations to support regional market access. These integrated capabilities ensure a seamless transition from development through to commercial launch.
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 commercial manufacturing services.