A workshop hosted by the National Academies of Sciences, Engineering, and Medicine in August 2018 on Continuous Manufacturing for the Modernization of Pharmaceutical Production, sponsored by the U.S. Food and Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority examined business, regulatory, and technical concerns associated with adopting continuous manufacturing techniques to produce biologics such as vaccines and gene therapy. This presentation will highlight primary issues identified by participants from industry, academia and regulatory agencies to be faced in developing and implementing continuous bioprocessing. Among the challenges identified for robust implementation of continuous manufacturing were criteria for segregation and assessing potential release of active agent produced continuously in response to a discrete adverse event. My lab has compared dynamics of sorption, diffusion, and dispersion of viral vectors on recovery, removal and residence time density in porous adsorptive media across a wide range of capacities, geometries and operating conditions. In this work we examine measurability and predictability of viral vector dynamics in fluidic biopharmaceutical systems, corresponding critical quality attributes and critical process parameters, and the potential impact of system design and operation on sequestration and release of viral vector in the event of adverse process event.

Scaling up vaccine bioprocessing: envisioning continuous biopharmaceutical vaccine bioprocesses

2019 Spring National Meeting

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