Approaches for Flexible Manufacturing Facilities in Vaccine Production - With careful analysis to mitigate risk, disposable technology and process closure can enable adaptable designs and reduced

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Approaches for Flexible Manufacturing Facilities in Vaccine Production
With careful analysis to mitigate risk, disposable technology and process closure can enable adaptable designs and reduced costs.


BioPharm International Supplements
pp. s22-s28

CONCLUSION

Process closure provides superior product protection and permits lower room classifications. A risk-based approach must be used to review the state of process system closure and to identify all connection points, evaluating their suitability with regard to the process and quality requirements. Manufacturing facilities that use these closed-system processes in combination with single-use technologies offer process flexibility; adaptable and expandable design; shortened construction, start-up, and validation schedules; as well as decreased utility costs, all of which have the potential to reduce the cost of vaccines.

REFERENCES

1. CDC, "Vaccine Price List," http://www.cdc.gov/, accessed Oct. 14, 2011.

2. UNICEF, "Vaccine Price Data 2001-2010," http://www.unicef.org/, accessed Oct. 14, 2011

3. President's Council of Advisors on Science and Technology, "Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza" (Aug. 2010).

4. ISO 14644-1, Cleanrooms and Associated Controlled Environments – Part 1: Classification of Air Cleanlines Cleanroom Standards (ISO, 1999).

5. European Commission, EudraLex Vol. 4: Good manufacturing practice (GMP) Guidelines, Annex 1: Manufacture of Sterile Medicinal Products (2003).

6. S. Chalk et al., BioPharm Intl. 24 (8) 44–65 (2011).

7. Newberger et al., Pharm. Eng. 28 (6), 1–7 (2008).


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