An Integrated Prefilled Syringe Platform Approach for Vaccine Development - Pharmaceutical Technology

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An Integrated Prefilled Syringe Platform Approach for Vaccine Development
The authors describe a holistic and integrated approach to focus on the linkage of the prefilled syringe with the four phases of product design, development, operation, and control.


Pharmaceutical Technology
Volume 37, Issue 5, pp. s12-s18

The benefit of using a standard set of prefilled syringe components consistently for a variety of products is that a solid and robust data package can be established to support licensure application. These categories of information include:

  • Description, general information, material of construction, method of manufacture
  • Suitability according to the FDA container closure guidance document which encompasses protection, compatibility, safety and performance
  • The quality control aspects such as incoming specifications, industry standards, etc.
  • Stability results, for example, will reveal some of the common stability issues and challenges depending on the product types, etc.
  • Manufacturability when new products in the same set of prefilled syringe are being transferred to production facility, where deep process knowledge of the platform prefilled syringe systems have been accumulated with definitive enhanced production efficiency and quality control.

This is important because it’s expected to provide all of this information in a submission as summarized in Table I.

Conclusion


Table I: General submission information requirement.
A holistic and integrated prefilled syringe platform toolbox approach will streamline development with higher probability of success even in the complex and challenging case of vaccine products. More importantly, such an approach is not only beneficial to technical challenges, but also provides economic benefits. We sincerely hope that the cost of innovation for a new prefilled syringe system is not so prohibitive that vaccine products cannot afford to achieve the intended health impact to society.

ACKNOWLEDGMENTS

We like to thank Anna Coslovi and Francesca Beccai for their preliminary results to characterize the charge heterogeneity of glycoconjugate vaccines.

REFERENCES

1. A-VAX Case Study, PDA, www.pda.org/Home-Page-Content/CMC-VWG-A-VAX.aspx, accessed Apr. 9, 2013.

2. L.X. Yu, Pharmaceutical Research, 25 (4), 781–791 (2008).

3. P.W. Tebbey and C. Rink, Journal of Medical Marketing, 9 (4), 301 – 307 (2009).

4. B.Y. Lee and S.M. McGlone, S.M., Human Vaccines, 6 (8), 619 – 626 (2010).

5. B.Y. Lee and D.S. Burke, Vaccine, 28 (16), 2806–2809 (2010).

6. L.S. Jones, L. S., A. Kaufmann and C.R. Middaugh, J Pharm Sci, 94(4), 918-927 (2005).

7. S. Hermeling et. al., Pharm Res 21(6), 897–903 (2004).

8. A.S. Rosenberg, AAPS Journal, 8(3), E501 – E507 (2006).

9. D. B. Ludwig, et. al., J. Pharm Sci, 9(4), 1721 – 1733 (2010).

10. A.R. Patel, D. Lau, J. Liu, Analytical Chemistry, 84, 6833 – 6840 (2012).

11. G. Giannini, R. Rappuoli, G. Ratti, Nucleic Acids Res, 12(10), 4063 – 4069 (1984).

12. L. Jodar, I.M. Feavers, D. Salisbury, D.M. Granoff, Lancet, 359, 1499 – 1508 (2002).


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