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Contents Bio Pharm I N T E R N AT I O N A L eBook Single-Use Systems 2019 MANUFACTURING Thinking Flexibly in Biomanufacturing Felicity Thomas Single-use systems may offer a suitably flexible solution to the biomanufacturing challenges of cost and time-to-market. 4 SUPPLY CHAIN New Strategies for Managing Single-Use Components Timothy Korwan and Jay Harp Redundancy should be built into the supply chain. 10 BUFFERS Buffers Benefit from Single-Use Systems Feliza Mirasol Single-use systems offer a solution to the challenges inherent in buffer preparation, which can be the cause of bottlenecking in bioprocessing. 14 COMPONENTS The Importance of Single-Use Components for Bioprocessing Feliza Mirasol Simple components help maintain physical integrity throughout a bioprocess setup, and single-use components play a role in ensuring a closed system for aseptic processing. 18 EXTRACTABLES AND LEACHABLES Extractables and Leachables: Determining Risk in Single-Use Systems Andreas Nixdorf As SUS become prevalent in the biologics industry, the question of safety becomes increasingly important. 20 COMMERICAL BIOREACTORS Single-use Bioreactors Unwrap Commercial Manufacturing Options Amber Lowry A review of various 2000-L single-use bioreactors used by biopharmaceutical suppliers for commercial production. 24 Ad Index 27 Cover: weerapat1003 - stock.adobe.com 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 © 2 0 19 M u l t i M e d i a H e a l t h c a r e L L C A l l r i g h t s r e s e r v e d . N o p a r t o f this public ation may be reproduced or tr ansmit ted in any form or by any means, 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 l u d i n g b y p h o t o c o p y, r e c o r d i n g , o r i n f o r m a t i o n s t o r a g e a n d r e t r i e v a l w i t h o u t p e r m i s s i o n 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. Authoriz ation to photocopy items for internal /educ ational or per sonal use, or the internal /educ ational or per sonal use of specific client s is gr anted by Mul tiMedia H e a l t h c a r e L L C f o r l i b r a r i e s a n d o t h e r u s e r s r e g i s t e r e d w i t h t h e C o p y r i g h t C l e a r a n c e C e n t e r, 2 2 2 R o s e w o o d D r. D a n v e r s , M A 0 19 2 3 , 9 7 8 -7 5 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 . 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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 Europe Correspondent Sean Milmo 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 June 2019 BioPharm International eBook 3