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Contents BioPharm I N T E R N AT I O N A L eBook 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 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 Advanstar UBM materials. PRODUCTION Production Manager Jesse Singer jsinger@hcl.com AUDIENCE DEVELOPMENT Audience Development Christine Shappell christine.shappell@ubm.com Thomas W. Ehardt Executive Vice-President, Senior Managing Director, UBM Life Sciences Group Dave Esola VP/Managing Director, Pharm/Science Group UBM Life Sciences © 2 018 UBM A ll r i gh t s r e s er ve d. No p ar t o f t his publi c a t ion m ay b e r epr o duc e d o r t r a n s m i t t e d i n a n y f o r m o r b y a n y m e a n s , e l e c t r o n i c o r m e c h a n i c a l i n c lu d i n g by pho to c opy, r e c or din g, or in for m a t ion s tor ag e a nd r e tr i e v a l w i t hou t p er mi s sion i n w r i t i n g f r o m t h e p u b l i s h e r. A u t h o r i z a t i o n t o p h o t o c o p y i t e m s f o r i n t e r n a l / e d u c a t i o n a l o r p e r s o n a l u s e , o r t h e i n t e r n a l / e d u c a t i o n a l o r p e r s o n a l u s e o f specific client s is gr anted by UBM for libr aries and other user s registered with the Copyr igh t Cle ar anc e C en ter, 2 2 2 Rosewood Dr. Danver s, M A 019 23, 978 -75 0 - 8 4 0 0 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: Jillyn.Frommer@ubm.com UBM Americas provides cer tain 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 ser vice 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 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. 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 Static Cover – Natash/Shutterstock.com Animated Cover – Shutterstock.com: Cattlaya Art, Promotive, Dmitry Kalinovsky, Victor Correia, Leonardo da, Julia.m, Traimak. MATERIALS Considering Silicone Tubing and Assemblies Jennifer Markarian . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 MANUFACTURING Biosimilars and Biobetters Strategies and Challenges Feliza Mirasol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 FILL/FINISH Single-Use Boosts Fill/Finish in Commercial Biomanufacturing Feliza Mirasol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 QUALIFICATION Qualification of Single-Use Systems Susan Haigney . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 QUALITY Managing Quality in Single-Use Systems Susan Haigney . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 SUPPLY CHAIN Assurance of Supply Adeline Siew . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 SHIPPING An Integrated Approach to Shipping Liquid in Single-Use Systems Elisabeth Vachette, Frederic Bazin, Magali Barbaroux, and Jean-Marc Cappia . . . . . . . . . . . . . 34 BIOREACTORS Comparing the Supply Lifecycle of Bioreactors Kenneth Clapp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Single-Use Systems 2018 www.biopharminternational.com June 2018 BioPharm International eBook 3