Methods of monitoring acceptance criteria of vaccine manufacturing systems

• US 20080319694A1
• Filed: 07/30/2008
• Published: 12/25/2008
• 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:
  US12/221,054
• Publication Number:
  US 20080319694A1
• Time in Patent Office: Days
• US Class Current: 702/84
• 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

Methods of monitoring an acceptance criteria of vaccine manufacturing processes are disclosed herein. Consequently, the methods and systems provide a means to perform high-quality manufacturing on an integrated level whereby vaccine manufacturers can achieve data and product integrity and ultimately minimize cost.

Claims

1. ) A method of monitoring an acceptance criteria of a vaccine manufacturing upstream processing system said method comprising,

a) monitoring data generated by an upstream processing system during vaccine manufacture;

b) maintaining the data over time to provide a historic record;

c) analyzing the historic record to provide a comparative analysis against an acceptance criteria;

d) taking corrective action during vaccine manufacture to obviate a rejection against the acceptance criteria whereby said corrective action comprises modifying said vaccine manufacture.

2. ) The method of claim 1, wherein the upstream processing system includes at least a bioreactor.

3. ) The method of claim 1, wherein the upstream processing system includes at least a media filtration system.

4. ) The method of claim 1, wherein the monitoring occurs at initial process.

5. ) The method of claim 1, wherein the monitoring is part of routine maintenance to assure conformance with vaccine manufacturing quality control.

6. ) The method of claim 1, wherein the data is generated by “

boundary value analysis”

or “

failure modes and effects”

analysis.

7. ) A method of monitoring an acceptance criteria of a vaccine manufacturing product separation system said method comprising,

a) monitoring data generated by a product separation system during vaccine manufacture;

b) maintaining the data over time to provide a historic record;

c) analyzing the historic record to provide a comparative analysis against an acceptance criteria;

d) taking corrective action during vaccine manufacture to obviate a rejection against the acceptance criteria whereby said corrective action comprises modifying said vaccine manufacture.

8. ) The method of claim 7, wherein the product separation system includes at least a cell incubator.

9. ) The method of claim 7, wherein the product separation system includes at least a depth filtration system.

10. ) The method of claim 7, wherein the monitoring occurs at initial process.

11. ) The method of claim 7, wherein the monitoring is part of routine maintenance to assure conformance with vaccine manufacturing quality control.

12. ) A method of monitoring an acceptance criteria of a vaccine manufacturing downstream processing system said method comprising,

a) monitoring data generated by a downstream processing system during vaccine manufacture;

b) maintaining the data over time to provide a historic record;

c) analyzing the historic record to provide a comparative analysis against an acceptance criteria;

d) taking corrective action during vaccine manufacture to obviate a rejection against the acceptance criteria whereby said corrective action comprises modifying said vaccine manufacture.

13. ) The method of claim 12, wherein the downstream processing system includes at least a purification chromatography system.

14. ) The method of claim 12, wherein the downstream processing system includes at least a liquid filtration system.

15. ) The method of claim 12, wherein the monitoring occurs at initial process.

16. ) The method of claim 12, wherein the monitoring is part of routine maintenance to assure conformance with vaccine manufacturing quality control.

17. ) The method of claim 12, wherein the data is generated by “

boundary value analysis”

or “

failure modes and effects”

analysis.

18. ) A method of monitoring an acceptance criteria of a vaccine manufacturing formulation and fill system said method comprising,

a) monitoring data generated by a formulation and fill system during vaccine manufacture;

b) maintaining the data over time to provide a historic record;

c) analyzing the historic record to provide a comparative analysis against an acceptance criteria;

d) taking corrective action during vaccine manufacture to obviate a rejection against the acceptance criteria whereby said corrective action comprises modifying said vaccine manufacture.

19. ) The method of claim 18, wherein the formulation and fill system includes at least a pH system.

20. ) The method of claim 18, wherein the monitoring is part of routine maintenance to assure conformance with vaccine manufacturing quality control.