AMRI offers a range of sterile lyophilization techniques at preclinical to clinical scale while using commercial-grade redundant components. Whether you have your own developed lyophilization cycle or would like assistance in process development, our engineering team will work with you to achieve your production goals in a cGMP-compliant environment. If stability characteristics indicate the need to move from liquid to lyophilized product design, our experts can minimize delay in formulation.

影音aV 影 先鋒A v電影 We provide lyophilization services for small molecules and complex biologics. Our complete suite of capabilities includes:

  • Formulation development services (compound stability, excipient selection)
  • Thermal properties assessments, including freeze-drying microscopy and differential scanning calorimetry (DSC)
  • Cycle development
  • Cycle optimization
  • Expertise in development and manufacturing of topical and injectable ophthalmics
  • Assessment of stability of lyophilized and reconstituted solution
  • Lyophilization unit with programmable recipe automation for repeatability of multiple lots

View our GMP lyophilization capabilities at our Albuquerque, Burlington, and Glasgow sites.

Albuquerque Manufacturing Capabilities: Lyophilization Capacity

Details

  • Total of 1,230 ft2 capacity across four freeze dryers
Vial SizeHull: 108 ft2Serail #3: 300 ft2Serail #4&5: 410 ft2
2 cc/13 mm tubing1063/tray = 38,268450/tray = 108,000450/tray = 151,424
5 cc/13 mm tubing640/tray = 23,040238/tray = 57,120238/tray = 79,834
5 cc/13 mm molded586/tray = 21,096238/tray = 57,120238/tray = 79,834
10 cc/13 mm tubing490/tray = 17,640194/tray = 46,560194/tray = 65,184
10 cc/20 mm molded490/tray = 17,640194/tray = 46,560194/tray = 65,184
20 cc/20 mm molded260/tray = 9,360114/tray = 27,360114/tray = 38,300
50 cc/20 mm molded144/tray = 5,18460/tray = 14,40060/tray = 20,384
100 cc/20 mm molded90/tray = 3,24035/tray = 8,40035/tray = 11,760

Burlington Manufacturing Capabilities: Lyophilization Capacity

Details

  • 36 ft2 shelf surface area
  • 1 GMP non-cyto/non-potent product lyophilizer
Vial SizeNumber of Vials
2 mL vials12,000
3 mL vials10,000
5/10 mL vials6,000
20 mL vials2,500
30 mL vials2,000

Glasgow Manufacturing Capabilities: Lyophilization Capacity

Details

  • 19 ft2 shelf surface area
  • 2 GMP lyophilizers: one for non-cytotoxic products and one for cytotoxic and highly potent products
Vial SizeNumber of Vials
2 mL9,250
5 mL3,230
10 mL2,800
20 mL1,950
30 mL1,880
50 mL945