Lyophilization methods and apparatuses

• US 20080098614A1
• Filed: 10/03/2007
• Published: 05/01/2008
• Est. Priority Date: 10/03/2006
• Status: Abandoned Application

• Current Assignee: Wyeth LLC (Pfizer Inc.)
• Original Assignee: Wyeth (Pfizer Inc.)
• Inventors: Warne, Nicholas, Tchessalov, Serguei
• Application Number:
  US11/906,622
• Publication Number:
  US 20080098614A1
• Time in Patent Office: Days
• US Class Current: 34/284
• CPC Class Codes: F26B 5/06 the process involving freezing

Abstract

A method and apparatus for optimizing the primary drying step of a lyophilization cycle of a biological or pharmaceutical material. In one aspect, the invention is a method for lyophilizing a material comprising the steps of calculating a designed primary drying cycle for the material based on a product temperature profile for the material and modifying both a chamber pressure and a shelf temperature according to a designed primary drying cycle during a primary drying step. In another aspect, the invention is an apparatus for lyophilizing a material according to a designed primary drying cycle comprising a computer-readable medium, a processor in electrical communication with the computer-readable medium, a chamber pressure module in electrical communication with the processor, and a shelf temperature module in electrical communication with the processor.

Claims

1. A method for lyophilizing a material comprising the step of modifying both a chamber pressure and a shelf temperature according to a designed primary drying cycle during a primary drying step.

2. The method of claim 1 further comprising the step of generating a designed primary drying cycle for the material based on a product temperature profile for the material.

3. The method of claim 2 further comprising the step of calculating the product temperature profile for the material based on a cake resistance of the material.

4. The method of claim 2 further comprising the step of calculating the product temperature profile for the material based on a vial heat transfer coefficient.

5. The method of claim 2 wherein the product temperature profile is calculated using product temperature data obtained during a primary drying step conducted in a laboratory, pilot or commercial lyophilizer.

6. The method of claim 1 wherein the designed primary drying cycle maintains a temperature of the material at or below a target temperature of the material.

7. The method of claim 1 wherein the designed primary drying cycle maintains a temperature of the material within about 15°

C. of a target temperature of the material.

8. The method of claim 7 wherein the designed primary drying cycle maintains the temperature of the material within about 5°

C. of the target temperature of the material.

9. The method of claim 1 wherein the chamber pressure and the shelf temperature are modified simultaneously.

10. The method of claim 1 wherein the material comprises a biological agent.

11. The method of claim 1 wherein the material comprises a pharmaceutical agent.

12. The method of claim 1 wherein the material comprises a solute having a concentration of protein in solution in the range of about 1 mg/ml to 150 mg/ml.

13. The method of claim 1 wherein the material comprises a solute having a concentration of protein in solution in the range of about 1 mg/ml to 50 mg/ml.

14. The method of claim 1 wherein the material comprises a bulking agent selected from the group consisting of sucrose, glycine, sodium chloride, lactose and mannitol.

15. The method of claim 1 wherein the material comprises a stabilizer selected from the group consisting of sucrose, trehalose, arginine and sorbitol.

16. The method of claim 1 wherein the material comprises a buffer selected from the group consisting of tris, histidine, citrate, acetate, phosphate and succinate.

17. The method of claim 1 wherein the primary drying step is conducted in a commercial-scale lyophilizer.

18. The method of claim 1 wherein the primary drying step is conducted in a pilot-scale lyophilizer.

19. The method of claim 1 wherein the primary drying step is conducted in a laboratory-scale lyophilizer.

20. An apparatus for lyophilizing a material comprising:

a) a computer-readable medium adapted to record a designed primary drying cycle;

b) a processor in electrical communication with the computer-readable medium and adapted to execute the designed primary drying cycle;

c) a chamber pressure module in electrical communication with the processor and adapted to modify a pressure of a lyophilization chamber in response to an instruction received from the processor; and

d) a shelf temperature module in electrical communication with the processor and adapted to modify a shelf temperature of a lyophilization chamber in response to an instruction received from the processor.