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 1046-2023Full text not available in this repository. (Request a copy from the Strathclyde author)
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.
|Keywords:||vaccines, manufacturing process, antibodies, quality control, commercial, Pharmacy and materia medica, Biochemistry, Genetics and Molecular Biology(all), Molecular Biology|
|Subjects:||Medicine > Pharmacy and materia medica|
|Department:||Faculty of Science > Strathclyde Institute of Pharmacy and Biomedical Sciences|
|Depositing user:||Strathprints Administrator|
|Date Deposited:||03 Oct 2011 12:09|
|Last modified:||29 Apr 2016 09:36|