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.
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 Size | Hull: 108 ft2 | Serail #3: 300 ft2 | Serail #4&5: 410 ft2 |
|---|---|---|---|
| 2 cc/13 mm tubing | 1063/tray = 38,268 | 450/tray = 108,000 | 450/tray = 151,424 |
| 5 cc/13 mm tubing | 640/tray = 23,040 | 238/tray = 57,120 | 238/tray = 79,834 |
| 5 cc/13 mm molded | 586/tray = 21,096 | 238/tray = 57,120 | 238/tray = 79,834 |
| 10 cc/13 mm tubing | 490/tray = 17,640 | 194/tray = 46,560 | 194/tray = 65,184 |
| 10 cc/20 mm molded | 490/tray = 17,640 | 194/tray = 46,560 | 194/tray = 65,184 |
| 20 cc/20 mm molded | 260/tray = 9,360 | 114/tray = 27,360 | 114/tray = 38,300 |
| 50 cc/20 mm molded | 144/tray = 5,184 | 60/tray = 14,400 | 60/tray = 20,384 |
| 100 cc/20 mm molded | 90/tray = 3,240 | 35/tray = 8,400 | 35/tray = 11,760 |
Burlington Manufacturing Capabilities: Lyophilization Capacity
Details
- 36 ft2 shelf surface area
- 1 GMP non-cyto/non-potent product lyophilizer
| Vial Size | Number of Vials |
|---|---|
| 2 mL vials | 12,000 |
| 3 mL vials | 10,000 |
| 5/10 mL vials | 6,000 |
| 20 mL vials | 2,500 |
| 30 mL vials | 2,000 |
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 Size | Number of Vials |
|---|---|
| 2 mL | 9,250 |
| 5 mL | 3,230 |
| 10 mL | 2,800 |
| 20 mL | 1,950 |
| 30 mL | 1,880 |
| 50 mL | 945 |