Carter K C, Ferro V A, Alexander J, Mullen A B
Department of Immunology, University of Strathclyde, 27 Taylor Street, Glasgow G4 0NR, UK.
Methods. 2006 Feb;38(2):65-8. doi: 10.1016/j.ymeth.2005.11.001.
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.
一种有效的实验性疫苗可能由于一些科学、监管或商业原因而无法成为治疗现实。在本综述中，我们分享一些作为大学研究人员的个人经历，并讲述在口服流感疫苗制剂的初步扩大规模和评估过程中遇到的一些问题。我们面临的许多问题都与科学无关，涉及确定项目资金来源、寻找符合GMP标准的合适合同制造公司以及保护科学研究产生的知识产权。本综述旨在作为一份实用指南，使其他研究人员能够采用有效策略，将有效的实验性制剂转化为可行的商业产品。
