Titel: Quality by Design for Biopharmaceuticals
Autoren/Herausgeber: Anurag S. Rathore, Rohin Mhatre (Hrsg.)
Aus der Reihe: Wiley Series on Biotechnology
Ausgabe: 1. Auflage
Anurag S. Rathore received his PhD in chemical engineeringfrom Yale University and is the Director of Process Development,Amgen Inc. His areas of interest include process development,scale-up, technology transfer, process validation, processanalytical technology, and quality by design. He has authored morethan 100 publications and presentations in these areas and serveson the editorial advisory boards for Biotechnology Progress,BioPharm International, Pharmaceutical Technology Europe, Journalof Biochemical and Biophysical Methods, and Separation andPurification Reviews.
Rohin Mhatre is a Senior Director in the BioProcessDevelopment department at Biogen Idec, Cambridge, Massachusetts,and has been with the company since 1996. His group is responsiblefor development of analytical methods and product characterizationto support the process and formulation development of early andlate stage clinical programs. Mhatre is also leading the QbDinitiative within Biogen Idec. He has authored several publicationsand been an invited speaker to numerous scientific meetings.