Optimized Vaccine Development and Manufacturing: A Technology Overview - Certain technology solutions can greatly improve the vaccine manufacturing process. - BioPharm International

ADVERTISEMENT

Optimized Vaccine Development and Manufacturing: A Technology Overview
Certain technology solutions can greatly improve the vaccine manufacturing process.


BioPharm International


Conclusion

Many opportunities to optimize vaccine development and manufacture can be found in the analytical and processing technologies used by commercial producers of other types of biopharmaceuticals. Today's technologies for various steps of vaccine manufacture can help ensure quality and reduce time. Some key technologies include analytical methods such as surface plasmon resonance, upstream technologies such as microcarrier beads for adherent cell lines, high-throughput screening methods for process development steps such as chromatography media selection, and downstream technologies such as cross-flow filtration. In all areas, disposable technologies are increasingly being adopted because they make it possible to develop and scale up processes quickly and to facilitate manufacturing by reducing the cleaning validation burden.

SILKE FETZER, PHD, is the head of product management cell culture, and vaccine operational marketing at GE Healthcare, Freiburg, Germany,

References

1. Heuer A, Editor's Note. The Bridge. 2006 Fall;36(3):3.

2. Wood JM, Mumford J, Schild GC, Wbster RG, Nicholson KG. Single-radial-immunodiffusion potency tests of inactivated influenza vaccines for use in man and animals. Dev Biol Stand. 1985;64:169–77.

3. Pol E, et al. Biosensor-based characterization of serum antibodies during development of an anti-IgE immunotherapeutic against allergy and asthma. J Mol Recognit. 2007 Jan-Feb;20(1):22–31.

4. Biacore AB and Boehinger Ingelheim Pharma, Germany. Fast In-Process and Quality Control. Application Note Biacore, GE Healthcare AB.

5. Development of immunotherapeutics and immunization regimes using Biacore T100, Application Note 79, GE Healthcare AB.

6. Metz B, Jiskoot W, Hennink WE, Crommelin DJ, Kersten, Vaccine. 2003 Dec 12;22(2):156–67.

7. US Food and Drug Administration. Guidance for Industry. Characterization and qualification of cell substrates and other biological starting materials used in the production of viral vaccines for the prevention and treatment of infectious diseases. Rockville, MD; 2006.

8. European Pharmacopoeia 5th Edition 5.06.

9. For requirements for seasonal influenza, see Michael Osterholm, Preparing for the Next Pandemic. New England J of Med. 2005 vol 352;18:1839–1843; for requirements for pandemic influenza, see Department of Health and Human Services, Vaccine Production in Cells. Available from http://www.pandemicflu.gov/vaccine/vproductioncells.html.

10. Ozturk SS. Engineering challenges in high density cell culture systems. Cytotechnology. 1996(22):3–16.

11. Malhaise E. Cell-culture based vaccine production. NAE/IOM topical conference: Technological Options. 2006 Apr 10–11;Cleveland, OH.

12. Aycardi E. Conference on Producing Vaccines for Developing Nations BioPharm. 2002(5):8–10.

13. Kistner O, et al. Development of safe and immunogenic mammalian cell (Vero) derived inactivated H5N1 whole virus candidate vaccine using the H5N1 wild type human isolate A/VietNam/1203/2004. Influenza Vaccines for the World conference. 2006; Vienna, Austria.

14. Coffman J, et al. High-Throughput Screening of Resins and Excipients for Downstream Process Development. IBC Bioprocess International Conference. 2004 Oct; Boston.

15. Kelley B, Switzer M, Booth J, Coffman J. Application of High Throughput Screening to a Mab Purification Platform. IBC Bioprocess International Conference. 2005 Sept; Boston.

16. Bezy P. Efficient Pilot Plant Utilization. Presented at IBC BioProcess International Conference. 2005 Apr; Berlin.

17. Kang Y, Cuttler MW, Quattara AA, Syvertsen KE. Purification processes for isolating purified vesicular stomatits virus from cell culture. United States patent publication no. US/2007 0249019 A1, published Oct 25, 2007.

18. Tal J. Adeno associated Virus-based Vectors in Gene Therapy. J Biomedical Sci. 2000(7):279–291 .


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

American CryoStem and Rutgers University File Joint Patent on Stem Cell Platform
April 11, 2014
PhRMA Report Reveals Growth Trajectories and Policy Factors Affecting Biopharmaceutical Growth
April 11, 2014
Center for Biologics Evaluation and Research Relocates
April 11, 2014
FDA Develops Alternative Assay to Increase Availability of Influenza Vaccines
April 10, 2014
Merck Announes Management Changes
April 7, 2014
Author Guidelines
Source: BioPharm International,
Click here