Covalidation strategies to accelerate analytical method transfer for breakthrough therapies

An important operation in the registration approval of a new drug product is the commercial-scale validation campaign at a receiving manufacturing site, which requires the technology transfer of analytical methodology from the transferring site. Traditionally, Bristol-Myers Squibb (BMS) used the com...

Ausführliche Beschreibung

Bibliographische Detailangaben

Veröffentlicht in:	Pharmaceutical technology Europe 2017-04, Vol.29 (4), p.25
Hauptverfasser:	O'Connor, Kieran, Hulme, Nicola, Shi, Yueer
Format:	Artikel
Sprache:	eng
Schlagworte:	Advertising campaigns Case studies Chromatography FDA approval Knowledge Laboratories Manufacturing Methods Pharmaceutical industry Product development R&D Research & development Technology transfer Testing laboratories
Online-Zugang:	Volltext
Tags:	Tag hinzufügen Keine Tags, Fügen Sie den ersten Tag hinzu!