2017
DOI: 10.1016/j.vaccine.2017.04.087
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An updated methodology to review developing-country vaccine manufacturer viability

Abstract: Highlights8 factors predict the viability of vaccine manufacturers in developing countries.These factors have evolved as the vaccine landscape has changed over 2 decades.A new analysis updates a framework first published in 1997 to assess viability.The updated framework is useful for assessing investments in vaccine manufacturers.

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Cited by 21 publications
(18 citation statements)
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“…The next most prominent barrier to investment in novel vaccines, reported by 50% of respondents, was a lack of technical expertise, which can include, and is not limited to, scientific, regulatory, and strategic expertise. However, to attain sufficient scientific and technical skills for vaccine manufacturing, low-resource countries are frequently required to import skilled labor, which greatly increases costs [12] , [16] . Further research is required to pinpoint the specific technical areas for which support would most benefit DCVMs.…”
Section: Resultsmentioning
confidence: 99%
See 1 more Smart Citation
“…The next most prominent barrier to investment in novel vaccines, reported by 50% of respondents, was a lack of technical expertise, which can include, and is not limited to, scientific, regulatory, and strategic expertise. However, to attain sufficient scientific and technical skills for vaccine manufacturing, low-resource countries are frequently required to import skilled labor, which greatly increases costs [12] , [16] . Further research is required to pinpoint the specific technical areas for which support would most benefit DCVMs.…”
Section: Resultsmentioning
confidence: 99%
“…Importantly, the sampled manufacturers have innovative strategies targeted for low- and middle-income markets, where infectious diseases’ burden is the greatest. However, the lack of commercial case often limits investments and stalls the development of needed novel and improved vaccines [13] , [16] . Moving forward manufacturers could enhance the capacity to build more detailed commercial insights, such as business cases and demand forecasting and careful cost structuring to incentivize more funding.…”
Section: Discussionmentioning
confidence: 99%
“…The ability and capacity to embrace opportunities remain a goal for many emerging vaccine manufacturers, but they often lack resources for significant changes to their operations [12] . While up-front investments (subsidies) are one response, this should be weighed against manufacturers' ability and capacity to adapt and adopt new technology [13] . Technology transfers constitute another option to support capacity building for manufacturers with scientific knowledge facilitating the transfer process [14] .…”
Section: Vaccine Supply Roadmap Considerations and Discussionmentioning
confidence: 99%
“…The best approach should be discussed early with the WHO PQ unit. Technology transfer Vaccine technology transfer requires extensive time and resources 64 . The process includes extensive documentation, asset transfers and training, as well as significant negotiations around intellectual property, liability, and data ownership.…”
Section: Chemistry Manufacturing and Controls Considerationsmentioning
confidence: 99%