Our specialized high potent manufacturing expertise is built on 35 years experience in potent processing and offers a purpose-built facility utilizing the very latest in containment technology. This enables the safe development and clinical and commercial supply of products with an occupational exposure limit (OEL) as low as 0.01µg/m3.
The facility itself has multiple levels of containment built into the design. Dispensing of API is undertaken within isolators and subsequent processes within appropriately contained equipment, ensuring operator safety and preventing cross contamination. Our fully integrated facility utilizes common equipment trains from development to commercial scale, utilizing geometric scale-up to deliver reproducibility and ultimately speed-to-market.
Contained Operations Overview:
- Multiple compound processing
- Development to commercial scale manufacturing and packaging
- Segregated people and material flow
- Secure access with client viewing gallery
- Automated cleaning procedures
- Contained engineering eliminating the need for personal protective equipment (PPE)
- HVAC system with single pass air
- Purpose-built, high performance, bespoke effluent treatment facility
- Design-for-manufacture delivering true speed-to-market
- Meeting regulatory standard for major markets including Japan, TMoH, the MHRA, FDA and ANVISA