The Case for QbD in Vaccine Development

Source: PharmaManufacturing.com

Aug 05, 2013

pda.org

Is it time for vaccine manufacturers to consider utilizing QbD principles in vaccine development? Leading experts from both industry and regulatory think so, and cite the A-VAX case study as proof.

Michael Washabaugh, PhD, Senior Director of Research Development at MedImmune,lists a number of compelling reasons to use the enhanced approach in vaccines development. For one, he said, it will modernize development. Here, vaccines manufacturers can take valuable lessons from biologics manufacturers who have pursued the QbD approach.

Second, there is a need for a more reliable supply of vaccines to meet public health demands “The assumption is that with a better understanding of your product and your process you should be able to maintain the supply,” he explained. Read more
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