Continuous monitoring methods in vaccine production

• US 20130006563A1
• Filed: 08/31/2012
• Published: 01/03/2013
• 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:
  US13/573,234
• Publication Number:
  US 20130006563A1
• 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

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 comprising,

a) establishing a quality control criteria for a vaccine manufacturing formulation and fill system;

b) monitoring said quality control criteria prior to release of a vaccine product during a vaccine manufacturing formulation and fill process;

c) analyzing said quality control criteria during said formulation and fill process to determine whether said quality control criteria have been achieved;

d) releasing a vaccine product when said quality control criteria have been achieved.

2. ) The method of claim 1, wherein the quality control criteria is based on humidity.

3. ) The method of claim 1, wherein the quality control criteria is based on temperature.

4. ) The method of claim 1, wherein the quality control criteria is based on photolysis.

5. ) The method of claim 1, wherein the monitoring occurs at initial formulation and fill process.

6. ) The method of claim 1, wherein the monitoring is continuous.

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

8. ) The method of claim 1, wherein the vaccine product is associated with a lot number.

9. ) The method of claim 1, wherein the vaccine product is produced by a plasmid (DNA) vaccine system.

10. ) A method comprising,

a) monitoring production of a vaccine product produced by a plasmid (DNA) vaccine system wherein said monitoring is initiated at a cell culture phase and wherein a quality control unit assigns a pre-determined acceptance criteria of said cell culture phase;

b) analyzing the acceptance criteria during said cell culture phase to determine if said acceptance criteria has been achieved;

c) transferring said cell culture to a fermentation phase wherein said quality control unit assigns a pre-determined acceptance criteria of said cell fermentation phase;

d) analyzing the acceptance criteria during said fermentation phase to determine if said acceptance criteria has been achieved.

11. ) The method of claim 10, further comprising taking corrective action during said fermentation phase to obviate a rejection against the acceptance criteria whereby said corrective action comprises modifying said fermentation phase.

12. ) The method of claim 10, further comprising transferring said cell culture to a harvesting phase wherein said quality control unit assigns a pre-determined acceptance criteria to said harvesting phase.

13. ) The method of claim 10, wherein the cell culture comprises a serum.

14. ) The method of claim 10, wherein the fermentation phase achieves a steady state.

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

16. ) The method of claim 10, wherein the monitoring is continuous.

17. ) The method of claim 10, wherein the monitoring is part of routine maintenance to assure conformance with vaccine manufacturing quality control.