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BioPharm March eBook - Outsourcing Resources

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Contents BioPharm I N T E R N AT I O N A L eBook T h e S ci e n ce & B usi n e ss o f B i o p h a r m a ce u t i c a ls © 2018 UBM 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. Authoriz ation to photocopy items for internal / educ ational or per sonal use, or the internal /educ ational or per sonal use of specific clients is granted by UBM for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 fa x 978-6 46-8700 or visit ht tp://w w w.copyright.com online. For uses beyond those listed above, please direct your writ ten request to Permission Dept. fa x 732-647-1104 or email: Jillyn.Frommer@ubm.com UBM Americas 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 Americas 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. B i o P h a r m I n t e r n a t i o n a l w e l c o m e s u n s o l i c i t e d a r t i c l e s , m a n u s c r i p t s , 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. Outsourcing Resources 2018 DRUG DEVELOPMENT Outsourcing: Does Focus Pay Off? Agnes Shanley 4 COMPLETE RESPONSE LETTERS Avoiding Complete Response Letters Agnes Shanley 7 QUALITY Quality Oversight During Sterile Filling Operations Philip Hoersch 11 QUALITY AGREEMENTS Good Quality Agreements Support Compliance with CGMP Paula Katz, Tamara Ely, Linda Joy, and Jessica Ritsick 16 PROCESS VALIDATION Process Validation in Biologics Development Susan Haigney 22 CONTRACT BIOMANUFACTURING Bigger is Better in Samsung's Approach to Biomanufacturing Rita Peters 24 ANALYTICS OUTSOURCING Choosing an Analytical Partner in Early Drug Development Feliza Mirasol 27 ANALYZING BIOLOGICS Gaining Analytical Insight in the Development of Biologics Susan Haigney 30 MARKET INVESTMENT Contract Services Investment Update Amber Lowry 33 Ad Index 35 Static Cover – Sukjai Photo Animated Cover – Shutterstock.com: Sukjai Photo, Hanna Kuprevich, Traimak, Docstockmedia, Kunst Bilder, Itsmejust, Angellodeco, Dextroza, Gajus. EDITORIAL Editorial Director Rita Peters rita.peters@ubm.com Senior Editor Agnes M. Shanley agnes.m.shanley@ubm.com Managing Editor Susan Haigney susan.haigney@ubm.com Science Editor Feliza Mirasol feliza.mirasol@ubm.com Science Editor Adeline Siew, PhD adeline.siew@ubm.com Manufacturing Editor Jennifer Markarian jennifer.markarian@ubm.com Associate Editor Amber Lowry amber.lowry@ubm.com Art Director Dan Ward dward@hcl.com Contributing Editors Jill Wechsler, Jim Miller, Eric Langer, Anurag Rathore, and Cynthia A. Challener, PhD Correspondent Sean Milmo (Europe, smilmo@btconnect.com) ADVERTISING Publisher Mike Tracey mike.tracey@ubm.com National Sales Manager Scott Vail scott.vail@ubm.com European Sales Manager Linda Hewitt linda.hewitt@ubm.com European Senior Sales Executive Stephen Cleland stephen.cleland@ubm.com C.A.S.T. Data and List Information Michael Kushner michael.kushner@ubm.com Reprints 877-652-5295 ext. 121/ bkolb@wrightsmedia.com Outside US, UK, direct dial: 281-419-5725. Ext. 121 PRODUCTION Production Manager Jesse Singer jsinger@hcl.com AUDIENCE DEVELOPMENT Audience Development Christine Shappell christine.shappell@ubm.com UBM LIFE SCIENCES Thomas W. Ehardt, Executive Vice-President, Senior Managing Director, UBM Life Sciences Group Dave Esola, VP/Managing Director, Pharm/Science Group, UBM Life Sciences www.biopharminternational.com March 2018 BioPharm International eBook 3

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