Novartis's Influenza Vaccine Program - The global head of technical operations at Novartis talks about new technologies for vaccine development and manufacturing. - BioPharm International

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Novartis's Influenza Vaccine Program
The global head of technical operations at Novartis talks about new technologies for vaccine development and manufacturing.

BioPharm International Supplements
Volume 24, pp. s17-s18

Q: Many people have said the cost of manufacturing vaccines in cells is prohibitive without government subsidies. The Holly Springs plant was built with a $485 million grant from the government. If the government had not bestowed this grant, would Novartis have built a cell-based manufacturing facility on its own?

Stober: New technologies are initially more expensive due to preliminary investment. Cell-based technology is an example of an innovation that required this type of investment. Once the technology is further developed and put into effect, the increased productivity makes the overall cost savings more apparent, which is why the partnership with the government was so important when building the facility. Additionally, cell-culture technology is beneficial because it provides a foundation for future biotechnology innovations.

Q: If vaccine production is seasonal, how will the plant be used in the off season?

Stober: The facility in Holly Springs, NC, was designed to be capable of producing seasonal flu cell-culture vaccine, pre-pandemic vaccine, and 150 million doses of pandemic vaccine within 6 months of an influenza pandemic declaration. Additionally, the site will have a fill–finish facility capable of producing both flu and non-flu products.

Q: Many companies are exploring the use of recombinant technologies for influenza vaccines. Does Novartis have such a program? If yes, please describe. If no, why not?

Stober: As a leader in innovative science and technology for vaccine development, Novartis Vaccines is not using only cell culture technology, but is also applying additional scientific breakthroughs such as adjuvants and reverse vaccinology to develop the most efficacious vaccines possible.

Reverse vaccinology is a method by which viruses such as influenza are generated from segments of DNA. For prospective pandemic influenza vaccines, reverse vaccinology can be a useful technology because the process does not require manufacturers to work directly with potentially highly infectious pandemic strains, rather only segments of the virus's genome.

Q: We understand that Novartis has a proprietary adjuvant. Could you describe what this adjuvant is and how it stimulates the immune system?

Stober: Novartis's proprietary adjuvant MF59 has an established safety profile. It is the only oil-in-water adjuvant supported by more than 12 years of post-marketing clinical safety data and more than 45 million doses of commercial use. The adjuvant has also been studied in randomized clinical trials and observational studies involving 124,000 individuals including children, adults, and elderly, and has been licensed for use in individuals 65 years of age and over in the seasonal influenza vaccine, FLUAD, since 1997 in the European Union. Benefits of vaccines produced with the MF59 adjuvant include established safety, immunogenicity, cross-reactivity, long-term boost-ability, T-cell immune memory, and antigen-sparing properties.

This article was an online exclusive bonus to the Pharmaceutical Technology October 2010 cover story, Vaccine Manufacturing Reborn.

Read more about vaccine development and manufacturing online

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Filterability and bacterial retention must be verified very early in process development to ensure successful sterilizing filtration validation.

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Adjuvant activity can be greatly improved by appropriate formulation of cytosine-phosphorothioate-guanine oligodeoxynucleotides (CpG ODNs).

Release and Stability Testing Programs for a Novel Virus-Like Particle Vaccine

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