Translation of an experimental oral vaccine formulation into a commercial product

Methods. 2006 Feb;38(2):65-8. doi: 10.1016/j.ymeth.2005.11.001.

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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Administration, Oral
  • Animals
  • Commerce / economics*
  • Cooperative Behavior
  • Drug Approval / economics
  • Humans
  • Immunity, Mucosal
  • Influenza Vaccines / administration & dosage
  • Influenza Vaccines / economics
  • Marketing / economics
  • Marketing / methods
  • Patents as Topic
  • Technology Transfer
  • Technology, Pharmaceutical / economics
  • Technology, Pharmaceutical / methods
  • Vaccines / administration & dosage
  • Vaccines / adverse effects
  • Vaccines / economics*

Substances

  • Influenza Vaccines
  • Vaccines