Drug Substance GMP & Non-GMP Manufacturing

Scale-up and pilot plant capabilities.

 

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

enables GMP monitoring of all key reaction parameters (pressure, temperature, etc.) and real-time process optimization


 

State-of-the-art dedicated material storage area

for safe storage of a range of chemical classes, and segregation of quarantine and released materials

A closer look at our capabilities and equipment:

  • 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
Contact Us
Discuss your next drug program with us today.