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Volume 28 Number 5 · PDF file 2018-09-11 · EMD Millipore Corporation Jerold Martin Sr. VP, Global Scientific Affairs, Biopharmaceuticals Pall Life Sciences Hans-Peter Meyer VP,

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  • BioPharm The Science & Business of Biopharmaceuticals

    INTERNATIONALINTERNATIONAL

    PEER-REVIEWED

    DIFFERENTIATION AND

    CHARACTERIZATION OF PROTEIN

    AGGREGATES AND OIL DROPLETS

    IN THERAPEUTIC PRODUCTS

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    May 2015

    Volume 28 Number 5

    MODULAR

    MANUFACTURING

    PLATFORMS FOR

    BIOLOGICS

    DOWNSTREAM

    PROCESSING

    FILTRATION TECHNOLOGIES

    ADVANCE TO MEET

    BIOPROCESSING NEEDS

    OUTSOURCING

    BIOMANUFACTURING

    OUTSOURCING

    GLOBALIZATION

    CONTINUES

    www.biopharminternational.com

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  • INTERNATIONAL

    BioPharm The Science & Business of Biopharmaceuticals

    EDITORIAL Editorial Director Rita Peters [email protected] Managing Editor Susan Haigney [email protected] Science Editor Randi Hernandez [email protected] Science Editor Adeline Siew, PhD [email protected] Community Editor Ashley Roberts [email protected] Art Director Dan Ward [email protected] Contributing Editors Jill Wechsler, Jim Miller, Eric Langer, Anurag Rathore, Jerold Martin, Simon Chalk, and Cynthia A. Challener, PhD Correspondent Sean Milmo (Europe, [email protected]) ADVERTISING

    Publisher Mike Tracey [email protected] West/Mid-West Sales Manager Steve Hermer [email protected] East Coast Sales Manager Scott Vail [email protected] European Sales Manager Chris Lawson [email protected] European Sales Manager Wayne Blow [email protected] Direct List Rentals Tamara Phillips [email protected] Reprints 877-652-5295 ext. 121/ [email protected] Outside US, UK, direct dial: 281-419-5725. Ext. 121 PRODUCTION Production Manager Jesse Singer [email protected] AUDIENCE DEVELOPmENT Audience Development Rochelle Ballou [email protected]

    UBm LIfE SCIENCES

    Joe Loggia, Chief Executive Officer Tom Ehardt, Executive Vice- President, Life Sciences Georgiann DeCenzo, Executive Vice-President Chris DeMoulin, Executive Vice-President Rebecca Evangelou, Executive Vice-President, Business Systems Julie Molleston, Executive Vice- President, Human Resources Mike Alic, Executive Vice-President, Strategy & Business Development Tracy Harris, Sr Vice-President Dave Esola, Vice-President, General Manager Pharm/Science Group Michael Bernstein, Vice-President, Legal Francis Heid, Vice-President, Media Operations Adele Hartwick, Vice-President, Treasurer & Controller

    UBm AmERICAS

    Sally Shankland, Chief Executive Officer Brian Field, Chief Operating Officer Margaret Kohler, Chief Financial Officer

    UBm PLC

    Tim Cobbold, Chief Executive Officer Andrew Crow, Group Operations Director Robert Gray, Chief Financial Officer Dame Helen, Alexander Chairman

    © 2015 Advanstar Communications Inc. All rights reserved. No part of this publication may 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 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 Inc. for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 fax 978-646-8700 or visit http://www.copyright.com online. For uses beyond those listed above, please direct your written request to Permission Dept. fax 440- 756-5255 or email: [email protected]

    UBM Life Sciences provides certain customer contact data (such as customers’ 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 want UBM Life Sciences to make your contact information available to third parties for marketing purposes, simply call toll-free 866-529-2922 between the hours of 7:30 a.m. and 5 p.m. CST and a customer service representative will assist you in removing your name from UBM Life Sciences’ 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 advertisements contained in the publication, and cannot take responsibility for any losses or other damages incurred by readers in reliance of such content.

    BioPharm International welcomes unsolicited articles, manuscripts, photographs, illustrations, and other materials but cannot be held responsible for their safekeeping or return.

    To subscribe, call toll-free 888-527-7008. Outside the U.S. call 218-740-6477.

    EDITORIAL ADVISORY BOARD BioPharm International’s Editorial Advisory Board comprises distinguished specialists involved in the biologic manufacture of therapeutic drugs, diagnostics, and vaccines. Members serve as a sounding board for the editors and advise them on biotechnology trends, identify potential authors, and review manuscripts submitted for publication.

    K. A. Ajit-Simh President, Shiba Associates

    Rory Budihandojo Director, Quality and EHS Audit

    Boehringer-Ingelheim

    Edward G. Calamai Managing Partner

    Pharmaceutical Manufacturing

    and Compliance Associates, LLC

    Suggy S. Chrai President and CEO

    The Chrai Associates

    Leonard J. Goren Global Leader, Human Identity

    Division, GE Healthcare

    Uwe Gottschalk Vice-President,

    Purification Technologies

    Sartorius Stedim Biotech GmbH

    Fiona M. Greer Global Director,

    BioPharma Services Development

    SGS Life Science Services

    Rajesh K. Gupta Vaccinnologist and Microbiologist

    Jean F. Huxsoll Senior Director, Quality

    Product Supply Biotech

    Bayer Healthcare Pharmaceuticals

    Denny Kraichely Associate Director

    Johnson & Johnson

    Stephan O. Krause Principal Scientist, Analytical

    Biochemistry, MedImmune, Inc.

    Steven S. Kuwahara Principal Consultant

    GXP BioTechnology LLC

    Eric S. Langer President and Managing Partner

    BioPlan Associates, Inc.

    Howard L. Levine President

    BioProcess Technology Consultants

    Herb Lutz Principal Consulting Engineer

    EMD Millipore Corporation

    Jerold Martin Sr. VP, Global Scientific Affairs,

    Biopharmaceuticals

    Pall Life Sciences

    Hans-Peter Meyer VP, Special Projects Biotechnology

    Lonza, Ltd.

    K. John Morrow President, Newport Biotech

    David Radspinner Global Head of Sales—Bioproduction

    Thermo Fisher Scientific

    Tom Ransohoff Vice-President and Senior Consultant

    BioProcess Technology Consultants

    Anurag Rathore Biotech CMC Consultant

    Faculty Member, Indian Institute of

    Technology

    Susan J. Schniepp Fellow

    Regulatory Compliance Associates, Inc.

    Tim Schofield Managing Director

    Arlenda, USA

    Paula Shadle Principal Consultant,

    Shadle Consulting

    Alexander F. Sito President,

    BioValidation

    Michiel E. Ultee Principal

    Ulteemit BioConsulting

    Thomas J. Vanden Boom Vice-President, Global Biologics R&D

    Hospira, Inc.

    Krish Venkat CSO

    AnVen Research

    Steven Walfish Principal Statistician

    BD

    Gary Walsh Professor

    Department of Chemical and

    Environmental Sciences and Materials

    and Surface Science Institute

    University of Limerick, Ireland

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  • 4 BioPharm International www.biopharminternational.com May 2015

    Contents

    BioPharm INTERNATIONAL

    BioPharm International integrates the science and business of

    biopharmaceutical research, development, and manufacturing. We provide practical,

    peer-reviewed technical solutions to enable biopharmaceutical professionals

    to perform their jobs more effectively.

    COLUMNS AND DEPARTMENTS

    BioPharm International ISSN 1542-166X (print); ISSN 1939-1862 (digital) is published monthly by UBM Life Sciences 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 change

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