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DEVELOPMENT
4 Building Data Quality
In Generates Quality Data Out
Cynthia A. Challener
MANUFACTURING
10 Complications in
Process Simulation Execution
James Agalloco
16 Instrumenting Single-Use Processes
Brandon Haschke
20 On Point: Biologics Drive
Growth in Pre-Filled Syringes
Felicity Thomas
24 Optimizing Viral
Vector Manufacturing
for Gene Therapy
João Marques, Matthew Dillingham, Paul Beckett,
Adina Paun, Youness Cherradi, Paul Carter, and Anissa Boumlic
QUALITY
30 Detecting Contamination
in Cell Therapies
Feliza Mirasol
OPERATIONS
34 Minimizing Contamination
During Biopharma R&D
David Phillips
38 Considerations in Contamination Control
Susan Haigney
42 Ad Index
Cover image: Uwe - stock.adobe.com; Cover design, Maria Reyes
Biologics and Sterile Drug
Manufacturing 2020
EDITORIAL
Editorial Director Rita Peters RPeters@mjhlifesciences.com
Senior Editor Agnes Shanley AShanley@mjhlifesciences.com
Managing Editor Susan Haigney SHaigney@mjhlifesciences.com
European Editor Felicity Thomas FThomas@mjhlifesciences.com
Manufacturing Editor Jennifer Markarian JMarkarian@mjhlifesciences.com
Science Editor Feliza Mirasol FMirasol@mjhlifesciences.com
Assistant Editor Lauren Lavelle LLavelle@mjhlifesciences.com
Senior Art Director Marie Maresco; Graphic Designer Maria Reyes
Contributing Editors Jill Wechsler jillwechsler7@gmail.com;
Hallie Forcinio editorhal@cs.com;
Susan J. Schniepp sue.schniepp@mac.com; Eric Langer info@bioplanassociates.com;
and Cynthia A. Challener, PhD challener@vtlink.net
Correspondent Sean Milmo (Europe, smilmo@btconnect.com)
485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA
Tel. 732.596.0276, Fax 732.647.1235, PharmTech.com
Address
485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA
Tel. 732.596.0276, Fax 732.647.1235
PharmTech.com
SALES
Publisher Mike Tracey MTracey@mjhlifesciences.com
East Coast Sales Manager Joel Kern JKern@mjhlifesciences.com
Mid West, West Coast Sales Manager BJ Ghiglione BGhiglione@mjhlifesciences.com
European Sales Manager Linda Hewitt LHewitt@mjhlifesciences.com
European Senior Sales Executive Stephen Cleland SCleland@mjhlifesciences.com
C.A.S.T. Data and List Information Michael Kushner MKushner@mjhlifesciences.com
VP/Managing Director, Pharm/Science Group Dave Esola
International Licensing Alexa Rockenstein ARockenstein@mjhlifesciences.com
Audience Development Research Director
Christine Shappell cshappell@mjhlifesciences.com
MJH LIFE SCIENCES
TM
Chairman and Founder Mike Hennessy, Sr
Vice Chairman Jack Lepping
President and CEO Mike Hennessy, Jr
Chief Financial Of ficer Neil Glasser, CPA/CFE
Executive Vice President, Operations Tom Tolvé
Executive Vice President, Global Medical Af fairs and Corporate Development
Joe Petroziello
Senior Vice President, Content Silas Inman
Senior Vice President, I.T. & Enterprise Systems John Moricone
Senior Vice President, Audience Generation & Product Fulfillment Joy Puzzo
Vice President, Human Resources & Administration Shari Lundenberg
Vice President, Business Intelligence Chris Hennessy
Executive Creative Director, Creative Services Jeff Brown