Translation of an experimental oral vaccine formulation into a commercial product.
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.
Carter
K C
KC
Department of Immunology, University of Strathclyde, 27 Taylor Street, Glasgow G4 0NR, UK.
Ferro
V A
VA
Alexander
J
J
Mullen
A B
AB
D000284:Administration, Oral; D000818:Animals; D003132:Commerce / Q000191:economics*; D003299:Cooperative Behavior; D017277:Drug Approval / Q000191:economics; D006801:Humans; D018928:Immunity, Mucosal; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000191:economics; D040541:Marketing / Q000191:economics / Q000379:methods; D010330:Patents as Topic; D018581:Technology Transfer; D013678:Technology, Pharmaceutical / Q000191:economics / Q000379:methods; D014612:Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics*
D007252:Influenza Vaccines; D014612:Vaccines