World Vaccine Congress Roundtable Summary

What are Common Causes of Analytical Method Transfer Failure?

WESTBROOK, ME (October 19, 2020) The recently convened 2020 World Vaccine Congress Virtual Event featured many excellent roundtable discussions by speakers from over 300 organizations.

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Presenters came from vaccine research and manufacturing companies such as GSK, Merck, Sanofi Pasteur, and Lilly, as well as clinicians from facilities such as Boston Children’s Hospital, Mayo Clinic, and Johns Hopkins, to name a few. In addition to these industry leaders, Dr. Anthony Fauci also joined the event to talk about the pandemic and how biopharmaceutical companies around the world are racing to develop safe vaccines.

COVID-19 and the potential vaccine solution was a hot topic of discussion in many of the panels and roundtables this year. One such discussion was moderated by Dr. Nathaniel Hentz of Artel, covering analytical issues impacting quality in vaccine development, of which typical sources of analytical method transfer failures drew the most discussion. Tight assay variability specifications, when the assay performance and its critical parts are not completely understood, are one such source of potential problems. Another source of variability was the use of different pipette tips between the transferring laboratory and the receiving laboratory. Operator training was shown as yet another common source of variability. Also discussed was the large window of variability surrounding the measurement of potency.

More detail on this and related topics are freely available from the Applications and Resource Library portals of Artel’s website.