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Translation of an experimental oral vaccine formulation into a commercial product

Carter, K.C. and Ferro, V.A. and Alexander, J. and Mullen, A. (2006) Translation of an experimental oral vaccine formulation into a commercial product. Methods, 38 (2). pp. 65-68. ISSN 1046-2023

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Abstract

An effective experimental vaccine may fail to become a therapeutic reality for a number of scientific, regulatory or commercial reasons. In this review, we share some of our personal experiences as University-based researchers and provide an account of some of the problems that we have encountered during preliminary scale-up and assessment of an oral influenza vaccine formulation. Many of the problems we have faced have been non-scientific and related to identifying project-funding sources, finding suitable contract manufacturing companies that are GMP compliant, and protecting intellectual property generated from the scientific studies. The review is intended as a practical guide that will allow other researchers to adopt effective strategies to permit the translation of an effective experimental formulation to a viable commercial product.