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Overview of Best Practices for Biopharmaceutical Technology Transfers

Authors :
John Bowers
Sushil Abraham
Jonathan Tsang
Heidi Kenty
Victor Larivee
David Bain
Jasmina Xie
Francisco Leira
Source :
PDA journal of pharmaceutical science and technology. 69(5)
Publication Year :
2015

Abstract

Technology transfer is a key foundational component in product commercialization. It is more than just the transfer of documents; it relates to all aspects of the transfer of knowledge and experience to the commercial manufacturing unit to ensure consistent, safe, and high-quality product. This is the first in a series of articles from the BioPhorum Operations Group (BPOG) member companies discussing best practices and benchmarking of biopharmaceutical technology transfer. In this article, we provide the common terminology developed by BPOG to accommodate both transferring and receiving organizations. We also review the key elements of a robust technology transfer business process, including critical milestones. Finally, we provide a brief overview of the articles in this series.

Details

ISSN :
19482124
Volume :
69
Issue :
5
Database :
OpenAIRE
Journal :
PDA journal of pharmaceutical science and technology
Accession number :
edsair.doi.dedup.....fca7adcfe34c285a15bc767749fca8f6