Quality-by-design for biotechnology-related pharmaceuticals.
The following article is a report from a workshop on Quality-by-Design (QbD) held at the 7th European Symposium on Biochemical Engineering Science (7 September 2008, Faro, Portugal).The aim of the workshop was to provide an update on the present status of using QbD in biotechnology-related applications in the pharmaceutical industry. The report summarizes the essential parts of the presentations and covers the industrial, academic, and regulatory aspects of QbD. It concludes with recommendations for further work and development.
Mandenius
Carl-Fredrik
CF
Linköping University, Sweden. cfm@ifm.liu.se
Graumann
Klaus
K
Schultz
Torsten W
TW
Premstaller
Andreas
A
Olsson
Ing-Marie
IM
Petiot
Emma
E
Clemens
Christoph
C
Welin
Mats
M
D001702:Biopharmaceutics / Q000379:methods / Q000592:standards; D019149:Bioreactors; D001709:Biotechnology / Q000379:methods / Q000592:standards; D004345:Drug Industry / Q000592:standards; D004493:Education; D005285:Fermentation; D008954:Models, Biological; D012107:Research Design / Q000592:standards