Drug Substance: GMP & Non-GMP Manufacturing

Our facilities can provide both GMP (Good Manufacturing Practice) and non-GMP drug substance manufacturing, with the ability to generate kilogram-per-day quantities.

• 5-L GMP and non-GMP process chemistry facilities with full thermal control
• 20-L GMP state-of-the-art reactor streams housed in dedicated walk-in fume cupboards with operating temperatures from -90°C up to +180°C
• Full integration of reactor stream data logging to a dedicated server, enabling GMP monitoring of all key reaction parameters (pressure, temperature etc.) and real-time process optimization
• State-of-the-art dedicated material storage area, enabling safe storage of a range of chemical classes and segregation of quarantine and released materials
• Flexible continuous manufacturing units (FlowSyn, trickle-bed, and Salamander reactors with pressure capabilities up to 50 bar and operating temperatures up to 180°C) – these equipment trains have the capacity to generate kilogram quantities of materials per day
• Automated parallel reactor streams with ReactIR and integrated calorimetry (HFCal) and off-gassing measurement capability
• Onsite 150-L reactors
• A range of isolation and drying options, including mobile filter dryers (316 stainless steel and Hastelloy MOC) with up to 15-kg capacities
• Containment systems for handling compounds up to and including SafeBridge Band 3