Drug Substance: GMP & Non-GMP Manufacturing

Quotient Sciences provides drug substance (API) 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

Kilo Lab/Pilot Plant Manufacturing

Quotient Sciences has access to scale-up and pilot plant assets that complement our on-site facilities, featuring a capacity range between 50 L and 1300 L capable of producing 5-100 kg in batch. Our internal manufacturing assets (batch, CSTR, trickle bed, and plug flow) range from multi-gram to multi-kilogram capacity (multi-tonne per annum capability).

We can meet drug substance requirements from pre-clinical through to full-scale commercial phases. The scale-up process is executed by a highly experienced manufacturing team, providing customers with a secure source of supply for technically challenging projects.

Additionally, our investment in innovative, flexible modular manufacturing technology enables us to quickly configure reactors for drug substance (API) manufacturing, then rapidly reassemble reactors for the next project.

Expanded drug substance manufacturing capabilities in Alnwick, UK