Quality by Design for Biopharmaceuticals by Anurag S. Rathore
Look inside with Google Book Preview
Quality by Design for Biopharmaceuticals
By Anurag S. Rathore

Quality by Design for Biopharmaceuticals

Principles and Case Studies

Edited by See other recent books by Anurag S. Rathore See other recent books by Rohin Mhatre
By (author) Anurag S. Rathore See other recent books by Anurag S. Rathore
Format: Hardback

Normal Price: $212.95
Your Price: $191.66 AUD, inc. GST
Shipping: $6.95 per order
You Save: $21.29! (10% off normal price)
Plus...earn $9.58 in Boomerang Bucks
Availability: Available Available to Backorder, No Due Date for Supply



Quality by Design for Biopharmaceuticals by Anurag S. Rathore

Book Description

This is the first book that explains the underlying concepts of Quality by Design (QbD) and the practical aspects of implementing QbD in biopharmaceutical manufacturing. A systematic approach leads the reader through a process, outlining the understanding of the critical quality attributes of the molecule, the development of the design space to meet the quality attributes, filing of the QbD information in regulatory documents, risk management, and the application of QbD. Complete with real-world case studies, this is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.

Buy Quality by Design for Biopharmaceuticals book by Anurag S. Rathore from Australia's Online Bookstore, Boomerang Books.


Book Details

ISBN: 9780470282335
ISBN-10: 0470282339
Format: Hardback
(241mm x 163mm x 23mm)
Pages: 312
Imprint: Wiley-Blackwell
Publisher: John Wiley and Sons Ltd
Publish Date: 1-Jul-2009
Country of Publication: United States

Books By Author Anurag S. Rathore


Reviews

» Have you read this book? We'd like to know what you think about it - write a review about Quality by Design for Biopharmaceuticals book by Anurag S. Rathore and you'll earn 50c in Boomerang Bucks loyalty dollars (you must be a member - it's free to sign up!)

Write a book review


Author Biography - Anurag S. Rathore

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.

Boomerang Bucks close

For every $20 you spend on books, you will receive $1 in Boomerang Bucks loyalty dollars. You can use your Boomerang Bucks as a credit towards a future purchase from Boomerang Books. Note that you must be a Member (free to sign up) and that conditions do apply.

Recent books by Anurag S. Rathore close
Process Validation in Manufacturing of Biopharmaceuticals by Anurag S. Rathore
»
Recent books by Rohin Mhatre close
Quality by Design for Biopharmaceuticals by Rohin Mhatre
»
Recent books by Anurag S. Rathore close
Process Validation in Manufacturing of Biopharmaceuticals by Anurag S. Rathore
Quality by Design for Biopharmaceuticals by Anurag S. Rathore
»
BoomerangBooks.com.au close