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Translation of an experimental oral vaccine formulation into a commercial product.
- Source :
-
Methods (San Diego, Calif.) [Methods] 2006 Feb; Vol. 38 (2), pp. 65-8. - Publication Year :
- 2006
-
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.
- Subjects :
- Administration, Oral
Animals
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
Commerce economics
Vaccines economics
Subjects
Details
- Language :
- English
- ISSN :
- 1046-2023
- Volume :
- 38
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Methods (San Diego, Calif.)
- Publication Type :
- Academic Journal
- Accession number :
- 16406571
- Full Text :
- https://doi.org/10.1016/j.ymeth.2005.11.001