RT Journal Article
SR Electronic
T1 Overview of Best Practices for Biopharmaceutical Technology Transfers
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 645
OP 649
DO 10.5731/pdajpst.2015.01086
VO 69
IS 5
A1 Sushil Abraham
A1 David Bain
A1 John Bowers
A1 Heidi Kenty
A1 Victor Larivee
A1 Francisco Leira
A1 Jasmina Xie
A1 Jonathan Tsang
YR 2015
UL http://journal.pda.org/content/69/5/645.abstract
AB 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.