Quality by Design for Biopharmaceuticals: Principles and Case StudiesISBN: 978-0-470-28233-5
Hardcover
328 pages
June 2009
This is a Print-on-Demand title. It will be printed specifically to fill your order. Please allow an additional 10-15 days delivery time. The book is not returnable.
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Anurag S. Rathore received his PhD in chemical engineering
from Yale University and is the Director of Process Development,
Amgen Inc. His areas of interest include process development,
scale-up, technology transfer, process validation, process
analytical technology, and quality by design. He has authored more
than 100 publications and presentations in these areas and serves
on the editorial advisory boards for Biotechnology Progress,
BioPharm International, Pharmaceutical Technology Europe, Journal
of Biochemical and Biophysical Methods, and Separation and
Purification Reviews.
Rohin Mhatre is a Senior Director in the BioProcess Development department at Biogen Idec, Cambridge, Massachusetts, and has been with the company since 1996. His group is responsible for development of analytical methods and product characterization to support the process and formulation development of early and late stage clinical programs. Mhatre is also leading the QbD initiative within Biogen Idec. He has authored several publications and been an invited speaker to numerous scientific meetings.