2011 Annual Meeting

(432g) Process Analytical Technology for Recombinant Pandemic Flu Vaccines: Viral Ultrastructure, Aggregation, and Binding

Authors

Leonard F. Pease - Presenter, University of Utah
De-Hao Tsai - Presenter, University of Maryland and NIST
Daniel Lipin - Presenter, University of Queensland
Suvajyoti Guha - Presenter, University of Maryland and NIST
Jeremy Feldblyum - Presenter, University of Maryland and NIST
Kenneth D. Cole - Presenter, National Institute of Standards and Technology
Kurt A. Brorson - Presenter, Food and Drug Administration (FDA)
Michael Zachariah - Presenter, University of Maryland
Anton P. J. Middelberg - Presenter, The University of Queensland


Here we describe our progress to develop electrospray differential mobility analysis (ES-DMA) into a process analytical technology (PAT) for recombinant vaccines.  The threat of pandemic flu (e.g. avian influenza H5N1, swine flu H1N1, etc.) remains a significant public concern.  Recombinantly produced vaccines hold significant advantages over traditional means of growing vaccines including increased production rates, shorter times between viral identification and clinical treatment, and improved safety profiles.  However, accelerated production methods also require advanced process control sensors (i.e. process analytical technologies) that can rapidly and accurately detect out of specification intermediates.  ES-DMA has the potential to fulfill this need.  Here we describe our efforts use ES-DMA to (1) rapidly quantify the assembly state and integrity of recombinantly produced virus like particles (VLPs), (2) determine the viral aggregation state, and (3) quantify antibody-virus binding necessary to determination of stoichiometry and vaccine efficacy.