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Biologics and Sterile
Manufacturing 2019
ASEPTIC MANUFACTURING
4 Unknown and
Unknowable
Russell Madsen and James Agalloco
CLEANROOM MONITORING
10 Distinguishing Between Cleanroom
Classification and Monitoring
James Agalloco, Russell Madsen, and James Akers
PREFILLED SYRINGES
14 Test Methods and Quality
Control for Prefilled Syringes
Cynthia A. Challener
ANALYTICS
20 A Study of Leachable Silicone Oil in
Simulated Biopharmaceutical Formulations
Xiaochun Yu, Nicholas Keyes, Neal Andrist, Ashley Hellenbrand,
Jeffery Nordin, and Roxanne Aide
MANUFACTURING
30 The Link Between
Manufacturing and Commercialization
in Gene and Cell Therapy
Walter Colasante, Pascale Diesel, and Lev Gerlovin
SUPPLY CHAIN
36 Supply Chain Challenges
for Single-Use Systems
Jennifer Markarian
BIOSIMILARS
42 Challenges with Successful
Commercialization of Biosimilars
Anurag S. Rathore, Arnold G. Vulto, James G. Stevenson,
and Vinod P. Shah
50 Ad Index
EDITORIAL
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Associate Editor Amber Lowry ALowry@mmhgroup.com
Art Director Dan Ward
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Thomas W. Ehardt
President, MultiMedia Healthcare LLC
Dave Esola
VP/Managing Director, Pharm/Science Group,
MultiMedia Healthcare LLC
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