Intelligent execution system for the monitoring and execution of vaccine manufacturing

• US 20080294361A1
• Filed: 05/14/2008
• Published: 11/27/2008
• Est. Priority Date: 05/24/2007
• Status: Abandoned Application

• Current Assignee: SMP Logic Systems LLC
• Original Assignee: SMP Logic Systems LLC
• Inventors: Popp, Shane M.
• Application Number:
  US12/152,409
• Publication Number:
  US 20080294361A1
• Time in Patent Office: Days
• US Class Current: 702/81
• CPC Class Codes: A61K 2039/53 DNA (RNA) vaccination
• CPC Class Codes: G06Q 10/06 Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
• CPC Class Codes: G06Q 50/04 Manufacturing
• CPC Class Codes: Y02P 90/30 Computing systems specially adapted for manufacturing

Abstract

Intelligent execution systems and methods thereof used to monitor and execute a vaccine manufacturing process are disclosed herein. Consequently, the methods and systems provide a means to perform validation and quality manufacturing on an integrated level whereby vaccine manufacturers can achieve data and product integrity and ultimately minimize cost.

Claims

1. ) An “

intelligent execution system”

(“

IES”

) by a process comprising,

a) contacting a plurality of devices used in vaccine manufacture with a computer memory having computer executable instructions;

b) monitoring data generated by said devices during vaccine manufacture;

c) maintaining the data to provide a historic record;

d) analyzing said data to make a quality assessment of said vaccine manufacture.

2. ) The IES of claim 1, wherein said device is a cell harvest system.

3. ) The IES of claim 1, wherein said device is a purification system.

4. ) The IES of claim 1, wherein said device is a bioreactor.

5. ) The IES of claim 1, wherein said device is a filtration system.

6. ) The IES of claim 1, wherein said data relates to an acceptance criteria of an active ingredient used to manufacture vaccines.

7. ) The IES of claim 1, wherein said data relates to an acceptance criteria of an in-process material used to manufacture vaccines.

8. ) The IES of claim 1, wherein said data relates to an acceptance criteria of an inactive ingredient used to manufacture vaccines.

9. ) The IES of claim 1, wherein said quality assessment further comprises modifying said vaccine manufacture.

10. ) The IES of claim 1, wherein the monitoring is continuous.

11. ) A kit comprising the IES of claim 1.

12. ) A method of monitoring a vaccine manufacturing process said method comprising,

a) deriving an algorithm implemented in computer-readable instructions that performs data analysis on a vaccine manufacturing process;

b) integrating said algorithm into a vaccine manufacturing process whereby actual monitoring of the vaccine manufacturing is attained.

13. ) The method of claim 12 further comprising maintaining a historical record of the data analysis.

14. ) The method of claim 12, wherein the vaccine manufacturing process is a plasmid (DNA) based process.

15. ) The method of claim 12, wherein the monitoring is part of routine maintenance.

16. ) A method of monitoring quality control of a vaccine manufacturing process said method comprising,

a) contacting a computer memory having computer executable instructions to a critical control point of a vaccine manufacturing process;

b) monitoring data generated by said critical control point during vaccine manufacture;

c) analyzing said data in a continuous manner during vaccine manufacture to ensure purity and consistency of an ingredient used in vaccine manufacture.

17. ) The method of claim 16, wherein the ingredient is an inactive ingredient.

18. ) The method of claim 16, wherein the vaccine manufacturing process is a plasmid (DNA) vaccine process using at least a chromatography system.

19. ) The method of claim 16, wherein the vaccine manufacturing process further comprises a downstream processing system.