BioPharm

Contents Outsourcing Resources 2019 CHEMISTRY, MANUFACTURING, AND CONTROLS CMC Due Diligence for Accelerated Biologic Drug Development and Manufacturing Yanhuai (Richard) Ding, Peggy Marino, Alex Praseuth, Joe Sheffer, Kevin Zen, and Hemant Kumar The growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important. . . . . . 4 QUALITY CONTROL Using the Multiple Attribute Method for Process Development and Quality Control Agnes Shanley More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes. . . .12 MANUFACTURING Complex and Customized: Manufacturing New Molecular Formats Andy Racher Increasingly complex monoclonal antibody molecules will require the right "tool box" for scaling up manufacturing. . . . . . . . . . .16 Navigating the Biologics Wave Felicity Thomas Contract manufacturing organizations need to adapt to successfully overcome the specific challenges posed by complex therapies. . . . . . . . . . . . . . . . . . 20 BIOANALYTICAL METHODS Emerging Therapies Test Existing Bioanalytical Methods Christina Satterwhite, Jessica St. Charles, Valerie Theobald, and Jenifer Vija Cell- and gene-therapy drug development programs demand novel and conventional bioanalytical methods that require specialized expertise for complex therapeutic classes. . . . . . . . . . . . . . . . .22 BUSINESS DEVELOPMENTS Outsourcing Expansions and Collaborations Susan Haigney CMOs and CDMOs continue to expand their offerings and services in the biologics arena. . . . . . . . . . . . . . .27 Ad Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Static Cover: Alexander Raths - adobe.stock.com Animated Cover: yoshitaka/tilialucida/ustas/Production Perig/ Davizro Photography/Monster Ztudio - adobe.stock.com BioPharm I N T E R N AT I O N A L eBook T h e S ci e n ce & B u si n e ss o f B i o p h a r m a ce u t i c a ls © 2019 MultiMedia Healthcare LLC All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical in c lu din g b y p h o t o c o p y, r e c or din g , or in f or m a t i o n s t or a g e a n d r e t r i e v a l w i t h o u t 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 MultiMedia Healthcare LLC for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 f a x 9 7 8 - 6 4 6 - 8 7 0 0 o r v i s i t h t t p : // w w w. c o p y r i g h t . c o m o n l i n e . F o r u s e s b e y o n d t h o s e l i s t e d a b o v e , p l e a s e d i r e c t y o u r w r i t t e n r e q u e s t t o P e r m i s s i o n D e p t . f a x 732-647-1104 or email: JFrommer@mmhgroup.com. MultiM edia H ealthcare LLC pr ov id e s c er t a in cus tomer c on t ac t d a t a (such a s customers' names, addresses, phone numbers, and e-mail addresses) to third par ties who wish to promote relevant products, ser vices, and other oppor tunities that may be of interest to you. If you do not want MultiMedia Healthcare LLC to make your contact infor mation available to thir d par ties for mar ke ting pur poses, simpl y c all toll-fr ee 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 MultiMedia Healthcare LLC 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 ar ticles, 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 Editorial Director Rita Peters RPeters@mmhgroup.com Senior Editor Agnes M. Shanley AShanley@mmhgroup.com Managing Editor Susan Haigney SHaigney@mmhgroup.com European Editor Felicity Thomas FThomas@mmhgroup.com Science Editor Feliza Mirasol FMirasol@mmhgroup.com Manufacturing Editor Jennifer Markarian JMarkarian@mmhgroup.com Associate Editor Amber Lowry ALowry@mmhgroup.com Art Director Dan Ward dward@hcl.com Contributing Editors Jill Wechsler, Eric Langer, Anurag Rathore, and Cynthia A. Challener, PhD Correspondent Sean Milmo (Europe, smilmo@btconnect.com) ADVERTISING Publisher Mike Tracey MTracey@mmhgroup.com National Sales Manager Scott Vail SVail@mmhgroup.com European Sales Manager Linda Hewitt LHewitt@mmhgroup.com European Senior Sales Executive Stephen Cleland SCleland@mmhgroup.com C.A.S.T. Data and List Information Michael Kushner MKushner@mmhgroup.com Licensing and Reuse of Content: Contact our official partner, Wright's Media, about available usages, license fees, and award seal artwork at Advanstar@wrightsmedia.com for more information. Please note that Wright's Media is the only authorized company that we've partnered with for MultiMedia Healthcare materials. PRODUCTION Production Manager Jesse Singer jsinger@hcl.com AUDIENCE DEVELOPMENT Audience Development Christine Shappell cshappell@mmhgroup.com Thomas W. Ehardt President MultiMedia Healthcare LLC Dave Esola VP/Managing Director, Pharm/Science Group MultiMedia Healthcare LLC www.biopharminternational.com April 2019 BioPharm International eBook 3

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