Biologics and Sterile
Drug Manufacturing 2021
MANUFACTURING
4 Sterile Filtration:
Reducing Risk, Ensuring Safety
Maik W. Jornitz
14 Filling Small Batches
Jennifer Markarian
18 Breaking the Cold Chain for Vaccines
Sam de Costa
ANALYTICS
26 Using ddPCR to Detect
Mycoplasma Contamination
Mark White
QUALITY/REGULATIONS
34 The Impact of COVID-19
on Biologics Regulations
Susan Haigney
OPERATIONS
38 Tracking Technologies
Safeguard Vaccine Cold Chain
Jennifer Markarian
44 Packaging Biologic
Drugs for Clinical Trials
Jennifer Markarian
49 Eyeing Up Success in Fill/Finish
Felicity Thomas
54 Reducing Packaging Costs
for Prefilled Syringes
Beth Totin and Marcus Webb
60 Biologics Facilities Expand
and Establish New Locations in 2021
Lauren Lavelle
62 Ad Index
Cover image: Leigh Prather - stock.adobe.com; Cover design, Maria Reyes
EDITORIAL
Editorial Director Rita Peters RPeters@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
Creative Director, Publishing Melissa Feinen
Senior Art Director Marie Maresco; Senior 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
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Address
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Tel. 732.596.0276, Fax 732.647.1235
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SALES
Publisher Mike Tracey MTracey@mjhlifesciences.com
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C.A.S.T. Data and List Information Michael Kushner MKushner@mjhlifesciences.com
Senior Vice President, Industry Sciences Michael Tessalone
Audience Development Research Director
Christine Shappell cshappell@mjhlifesciences.com
MJH LIFE SCIENCES
TM
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Vice Chairman Jack Lepping
President and CEO Mike Hennessy, Jr
Chief Financial Of ficer Neil Glasser, CPA/CFE
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Executive Vice President, Global Medical Af fairs and Corporate Development
Joe Petroziello
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