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15 30 974 92 238 029 75 186 207,277 2 1 4134 1 2 5596 1 5. 44 30 1132 3180,Ne 3s23p3 Rn 5f36d7s2 Xe 4f145d56s2. 1 82 3 4 5 19 0 3 4 5 6 19 0 1 2 4 6 7, 34 78 96 91 231 036 88 2326 025 22 47 867 8 15 999 7 14 007 16 32 07. 685 2 5 1600 1 1 1536 3289 1 6 182 82 3 5 195 65 3 1 444 75 2 4. Se Pa Ra Ti O N S,221 700 1670 222 65 209 86 115 36. Ar 3d104s24p4 Rn 5f26d7f2 Rn 7s2 Ar 3d24s2 He 2s22p4 He 2s22p3 Ne 3s23p4. 4 79 2 4 6 4 79 4 5 5 0 2 5 0 3 4 1 43 2 1 25 2 3 4 5 2 07 2 3 4 5. Hydroxyapatite resin for the puri cation of biomolecules. Available October 21st from Tosoh Bioscience, TOSOH BIOSCIENCE LLC Customer service 866 527 3587 Technical service 800 366 4875 option 3.
Tosoh Bioscience is a registered trademark of Tosoh Corporation. www tosohbioscience com, black ES524450 BP1114 CV2 FP pgs 10 30 2014 22 27 ADV. I N T E R N AT I O N A L,The Science Business of Biopharmaceuticals. EDITORIAL EDITORIAL ADVISORY BOARD, Editorial Director Rita Peters rpeters advanstar com BioPharm International s Editorial Advisory Board comprises distinguished. Managing Editor Susan Haigney shaigney advanstar com specialists involved in the biologic manufacture of therapeutic drugs. Science Editor Randi Hernandez rhernandez advanstar com diagnostics and vaccines Members serve as a sounding board for the. editors and advise them on biotechnology trends identify potential. Science Editor Adeline Siew PhD asiew advanstar com. authors and review manuscripts submitted for publication. Community Editor Ashley Roberts aroberts advanstar com. Art Director Dan Ward dward media advanstar com,K A Ajit Simh Jerold Martin. Contributing Editors Jill Wechsler Jim Miller Eric Langer. President Shiba Associates Sr VP Global Scientific Affairs. Anurag Rathore Jerold Martin Simon Chalk and Cynthia A Challener PhD. Biopharmaceuticals, Correspondents Hellen Berger Latin South America hellen Rory Budihandojo Pall Life Sciences.
berger terra com br Jane Wan Asia wanjane live com sg Director Quality and EHS Audit. Sean Milmo Europe smilmo btconnect com Boehringer Ingelheim Hans Peter Meyer. VP Special Projects Biotechnology,ADVERTISING Edward G Calamai Lonza Ltd. Publisher Mike Tracey mtracey advanstar com Managing Partner. West Mid West Sales Manager Steve Hermer shermer advanstar com Pharmaceutical Manufacturing K John Morrow. East Coast Sales Manager Scott Vail svail advanstar com and Compliance Associates LLC President Newport Biotech. European Sales Manager Chris Lawson clawson advanstar com. Suggy S Chrai David Radspinner, Senior Sales Executive Christine Joinson cjoinson advanstar com Global Head of Sales Bioproduction. President and CEO, Direct List Rentals Tamara Phillips tphillips advanstar com The Chrai Associates Thermo Fisher Scientific. Reprints 877 652 5295 ext 121 bkolb wrightsmedia com. Outside US UK direct dial 281 419 5725 Ext 121 Leonard J Goren Tom Ransohoff. Global Leader Human Identity Vice President and Senior Consultant. PRODUCTION Division GE Healthcare BioProcess Technology Consultants. Production Manager Jesse Singer jsinger media advanstar com. Uwe Gottschalk Anurag Rathore, AUDIENCE DEVELOPmENT Vice President Biotech CMC Consultant. Audience Development Rochelle Ballou rballou advanstar com Purification Technologies Faculty Member Indian Institute of. Sartorius Stedim Biotech GmbH Technology,Fiona M Greer Susan J Schniepp.
Global Director Vice President, BioPharma Services Development Quality and Regulatory Affairs. SGS Life Science Services Allergy Laboratories Inc. Rajesh K Gupta Tim Schofield,Managing Director,Vaccinnologist and Microbiologist. Arlenda USA, Joe Loggia Chief Executive Officer Tom Ehardt Executive Vice Jean F Huxsoll. Paula Shadle, President Chief Administrative Officer Chief Financial Officer Senior Director Quality. Principal Consultant, Georgiann DeCenzo Executive Vice President Chris DeMoulin Executive Product Supply Biotech.
Shadle Consulting, Vice President Rebecca Evangelou Executive Vice President Business Bayer Healthcare Pharmaceuticals. Systems Julie Molleston Executive Vice President Human Resources. Alexander F Sito, Tracy Harris Sr Vice President Dave Esola Vice President General Denny Kraichely. Manager Pharm Science Group Michael Bernstein Vice President Associate Director. BioValidation, Legal Francis Heid Vice President Media Operations Adele Hartwick Johnson Johnson. Vice President Treasurer Controller,Michiel E Ultee. Stephan O Krause Chief Scientific Officer,Principal Scientist Analytical.
Laureate BioPharmaceutical Services Inc, 2014 Advanstar Communications Inc All rights reserved No part of this publication may Biochemistry MedImmune Inc. be reproduced or transmitted in any form or by any means electronic or mechanical including. by photocopy recording or information storage and retrieval without permission in writing from. Thomas J Vanden Boom, Steven S Kuwahara Vice President Global Biologics R D. the publisher Authorization to photocopy items for internal educational or personal use or the. internal educational or personal use of specific clients is granted by Advanstar Communications. Principal Consultant,Hospira Inc, Inc for libraries and other users registered with the Copyright Clearance Center 222 Rosewood Dr GXP BioTechnology LLC. Danvers MA 01923 978 750 8400 fax 978 646 8700 or visit http www copyright com online Krish Venkat. For uses beyond those listed above please direct your written request to Permission Dept fax Eric S Langer CSO. 440 756 5255 or email mcannon advanstar com,President and Managing Partner AnVen Research. Advanstar Communications Inc provides certain customer contact data such as customers. BioPlan Associates Inc, names addresses phone numbers and e mail addresses to third parties who wish to promote.
relevant products services and other opportunities that may be of interest to you If you do not Steven Walfish. want Advanstar Communications Inc to make your contact information available to third parties for Howard L Levine Principal Statistician. marketing purposes simply call toll free 866 529 2922 between the hours of 7 30 a m and 5 p m President BD. CST and a customer service representative will assist you in removing your name from Advanstar s BioProcess Technology Consultants. lists Outside the U S please phone 218 740 6477, BioPharm International does not verify any claims or other information appearing in any of the. Gary Walsh, advertisements contained in the publication and cannot take responsibility for any losses or other. Herb Lutz Professor, damages incurred by readers in reliance of such content Principal Consulting Engineer Department of Chemical and. BioPharm International welcomes unsolicited articles manuscripts photographs illustrations EMD Millipore Corporation Environmental Sciences and Materials. and other materials but cannot be held responsible for their safekeeping or return and Surface Science Institute. To subscribe call toll free 888 527 7008 Outside the U S call 218 740 6477 University of Limerick Ireland. black ES521010 BP1114 003 pgs 10 28 2014 23 16 ADV. I N T E R N AT I O N A L,BioPharm International integrates. the science and business of,biopharmaceutical research development.
Contents and manufacturing We provide practical,peer reviewed technical solutions. Volume 27 Number 11 November 2014 to enable biopharmaceutical professionals. to perform their jobs more effectively,GENE AND CELL THERAPY FORMULATION DEVELOPMENT. ON THE WEB,www biopharminternational com, Vector Manufacturing and DoE Provides Benefits but. Testing for Gene and Cell Preparation Is Necessary. Social Media,Therapy Applications Cynthia A Challener. Wolf Klump Martin Wisher Defining critical parameters and processing. Alison Armstrong and Audrey Chang large quantities of data can be a challenge 28 Follow us on Twitter BioPharmIntl. The authors offer insight into cell,therapy manufacturing vector GLOBAL PERSPECTIVES.
production and the safety aspects Germany Post AMNOG. of testing for characterization 14 Insights for BioPharma Join our BioPharmInternational Group. Jill E Sackman and Michael J Kuchenreuther, Standardizing Practices for The authors take a look at some of the recent. Cellular Therapy Manufacturing developments in the German market 30 Single Use Systems eBook. Uplaksh Kumar and Naynesh R Kamani Be sure to check. ebook series,INTERNATIONAL, Cellular therapy developers learn Setting Standards for out BioPharm The Science Business of Biopharmaceuticals. International s,November 2014,Biotech Therapeutics in India. www biopharminternational com,process development strategies. from pharma industry experiences 24 Renu Jain M Kalaivani Secure Secure Single Use. Gunjan Narula and G N Singh Single uSe Systems eBook. SyStemS for articles on,The authors take a look at the best practices.
past and future impact of the disposable,Indian Pharmacopoeia Commission 35 chromatography. solutions trends in single use,bioreactors and more Download the. COLUMNS AND DEPARTMENTS eBook at BioPharmInternational com. eBook Series,6 From the Editor 42 Troubleshooting,The US public catches Challenges remain for. Ebola hype but lacks virus removal and validation, initiative for influenza prevention Cynthia A Challener. Rita Peters,Volume 27 Number 11,45 Analytical Best Practices INTERNATIONAL.
8 Regulatory Beat The ability to define a November 2014 The Science Business of Biopharmaceuticals. Manufacturers face regulatory scientifically justified and www biopharminternational com. overhaul while brand generic statistically sound sampling. debates escalate over biosimilars procedure is a fundamental skill. and labeling changes Thomas A Little,Jill Wechsler. 48 Ad Index,12 Perspectives on Outsourcing cell therapy. European CDMOs want to 49 Product Spotlight ManufacturinG. get into the US market but 49 New Technology Showcase forMulation. DEsIgN Of ExpERImENTs,pROvIDEs BENEfITs,Global Markets. gERmANy pOsT AmNOg,sETTINg sTANDARDs fOR,troubleshootinG. vIRAL cLEARANcE,chALLENgEs,entry options are limited.
BIOTEch ThERApEuTIcs IN INDIA, Jim Miller 50 The Word Cover REB Images Getty Images. BioPharm International is selectively abstracted or indexed in Biological Sciences Database Cambridge Scientifc Abstracts Biotechnology. and Bioengineering Database Cambridge Scientifc Abstracts Biotechnology Citation Index ISI Thomson Scientifc Chemical Abstracts CAS. Science Citation Index Expanded ISI Thomson Scientifc Web of Science ISI Thomson Scientifc. BioPharm International ISSN 1542 166X print ISSN 1939 1862 digital is published monthly by Advanstar Communications Inc 131 W First Street Duluth MN 55802 2065 Subscription. rates 76 for one year in the United States and Possessions 103 for one year in Canada and Mexico all other countries 146 for one year Single copies prepaid only 8 in the United States. 10 all other countries Back issues if available 21 in the United States 26 all other countries Add 6 75 per order for shipping and handling Periodicals postage paid at Duluth MN 55806 and. additional mailing offices Postmaster Please send address changes to BioPharm International PO Box 6128 Duluth MN 55806 6128 USA PUBLICATIONS MAIL AGREEMENT NO 40612608 Return. Undeliverable Canadian Addresses to IMEX Global Solutions P O Box 25542 London ON N6C 6B2 CANADA Canadian GST number R 124213133RT001 Printed in U S A. 4 BioPharm International www biopharminternational com November 2014. black ES521018 BP1114 004 pgs 10 28 2014 23 17 ADV. Predictable process scaling,Xcellerex bioreactor platform. Xcellerex XDR systems offer the bene ts of single use technology in a stirred tank. bioreactor design Developed for scalability and robustness the XDR platform. provides the performance and exibility needed from process development to. large scale biopharmaceutical manufacturing,upstream downstream single use services. When you need a exible and scalable cell culture solution we are a partner. like no other,www gelifesciences com BioProcess, GE and GE monogram are trademarks of General Electric Company Xcellerex is a trademark of General Electric Company or one of its subsidiaries. 2014 General Electric Company All rights reserved First published Oct 2014. GE Healthcare Bio Sciences AB Bj rkgatan 30 751 84 Uppsala Sweden. 29 1333 79 AA 10 2014, black ES524453 BP1114 005 FP pgs 10 30 2014 22 27 ADV.
From the Editor,Hype vs Health, bola virus disease EVD which first appeared in Africa 38 years ago gen. erally was perceived by people in developed nations as a scary deadly but. distant illness far removed from their lives, EVD is a severe often fatal disease that is transmitted human to human. through bodily fluids According to World Health Organization WHO data. nearly 2000 people in Africa were infected with EVD from 1976 through 2013. with an average fatality rate of 50 The latest outbreak began in March 2014 in. Guinea and spread to Sierra Leone Liberia Senegal and Nigeria As of Oct 14. WHO reported 9216 confirmed probable or suspected cases of EVD worldwide. and 4555 deaths, Rita Peters is the When the first patient with EVD walked into a US hospital the facility was. editorial director of not prepared two nurses treating the patient were infected Despite initial mis. BioPharm International steps federal and local officials c. Biotech CMC Consultant Faculty Member Indian Institute of Technology Susan J Schniepp Vice President Quality and Regulatory Affairs Allergy Laboratories Inc Tim Schofield Managing Director Arlenda USA Paula Shadle Principal Consultant Shadle Consulting Alexander F Sito President BioValidation Michiel E Ultee Chief Scientific Officer

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