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RSSSpeeding Vaccine Production Techniques
March 22, 2006
East Hills, NY - The new FDA initiative aimed at expediting the development of seasonal and pandemic flu vaccines underscores the universal drive to improve the quality and timeliness of vaccine availability. Whether targeting avian flu, cancer or bacterial diseases, all vaccine development and production processes benefit from the use of technologies that reduce the risk of contamination, improve harvesting, increase throughput and eliminate the need for cleaning and cleaning validation. Technologies that speed time-to-market and enhance the quality of next generation vaccines are the subject of a presentation given recently at the World Vaccine Congress by Dr. Hélène Pora, Vaccine Application Development Director, Pall Corporation (NYSE: PLL).
Dr. Pora focuses on two key areas that can adversely affect the safe production of vaccines: cleaning/cleaning validation and separation and purification.
"Thirty to fifty percent of all warning letters from the FDA are related to cleaning," says Dr. Pora. "The use of disposables, which eliminate both cleaning and cleaning validation, will clearly minimize the risk of non-compliance in the production of vaccines. The fact that 70 percent of development and production time is devoted to quality and safety controls underscores the importance of eliminating unnecessary steps like cleaning through the use of disposables."
Dr. Pora's presentation identifies increased purity, better characterization, improved product stability, and simplified production and compliance as critical to improving quality and time-to-market of new vaccines. She also discusses methods to significantly reduce the 30 or more steps required to separate and purify conjugate vaccines as another way to improve quality and time-to-market.
Beyond efficiency benefits, Pora points out the higher throughput of ultrafiltration over size exclusion chromatography. This is of particular importance during fractionation for protein and saccharide components of conjugate vaccines. These vaccines protect infants and young children from infectious diseases such as meningitis and invasive pneumonia.
Pora makes the case for the synergistic benefits of integrating TFF units and membrane chromatography into larger disposable systems using Pall's CentrasetteTM ultrafiltration technology and MustangTM membrane capsules as examples. She points to the elimination of cleaning and cleaning validation, improved operator safety, reduced cross-contamination risks, and lower installation, labor, and maintenance costs as reasons for adopting these technologies.
A disposable, pre-packed membrane column can remove contaminants at up to 100 times the speed of resin-based chromatography. Membrane chromatography is also shown to provide an efficient alternative to traditional resin chromatography for capture steps in virus- and plasmid-based gene therapy and vaccine purification applications, demonstrating the technology's application beyond contaminant removal. This technology can therefore play a significant role in reducing production time and enables the accelerated production of novel viral and DNA-based vaccines.
Pora concludes that advanced technologies will not only improve capacity, flexibility and availability of new vaccines, but that they will also help shape regulatory policy of this $10 billion market.
SOURCE: Pall Life Sciences
