APR January/February 2022 - 4

IN THIS ISSUE
»
10 INSIDER INSIGHT
Computer Vision is Providing a New Lens Into Biopharma Innovation
Carlos Melendez, Chief Operating Officer
Wovenware
20 FORMULATION AND DEVELOPMENT
Improving Preclinical Drug Safety by Evaluating Cytokine Release
Syndrome in Humanized Mice
James Keck, PhD, Senior Director, Innovation and Product Development
The Jackson Laboratory
28 DRUG DEVELOPMENT
Process Steps from Cell-Line Preparation to Manufacture of
Personalized Medicines
Robert Dream, Managing Director
HDR Company LLC
40 MANUFACTURING
Large Molecules, Small Batches: Understanding the Sterile Fill-Finish
Needs of Pharma's Emerging Market
Alex Garner, Director of Formulation and Clinical Trial Manufacturing
Frank Manella, Consultant
Khanh Ngo Courtney, PhD, Sr. Director of Biologics
Element
43 INSTRUMENTATION
European Pharmacopoeia Approach to Testing for Pyrogenicity
Emmanuelle Charton, PhD, Head of Division B, European Pharmacopoeia Department,
European Directorate for the Quality of Medicines & HealthCare (EDQM),
Council of Europe, Strasbourg, France
SPECIAL FEATURES
8
9
46 MANUFACTURING
The Cloud Does Not Bite!
Agata Mizera, GRC Lead
Capgemini
56 MICROBIOLOGY
Validation Strategy for New Recombinant Factor C Users
Evelyn Der, Senior Scientist
Roche Genentech, QC Technology Innovation and Implementation Group
Carmen Marin, QC Scientist Microbiology
F. Hoffmann La Roche Ltd.
Viviane Grunert da Fonseca, PhD, Non-clinical Statistician
Roche, MSAT (Manufacturing, Science and Technology)
Lindsey Silva, PhD, QC Director
Roche Genentech, Microbiology
62 FORMULATION AND DEVELOPMENT
Enabling Technologies Consortium: Implementations of
Wearable Enhanced Knowledge and Analytics Platforms
for Pharmaceutical Laboratories
Len Blackwell,1 Brian Good,2
1Biogen
2Eli Lilly
3
Geoffrey Kinnel3
& Peter Tattersall3
Bristol Myers Squibb
70 FORMULATION AND DEVELOPMENT
mRNA: A New Frontier in Vaccines and Medicine
Vanessa Elharrar, Vice President, PPD Clinical Research Services
Thermo Fisher Scientific
Martina Kovac, Vice President, PPD Clinical Research Services
Thermo Fisher Scientific
Anusha Streubel, Executive Medical Director, PPD Clinical Research Services
Thermo Fisher Scientific
CNPerspectives
Social Media Connections
SPONSORED CONTENT
36
INTERVIEWS
24
38
QC Corner with MilliporeSigma
Kenneth Laderman, PhD
Director of Manufacturing, Eurofins Advantar Laboratories, Inc.
Lee Madrid, PhD
Head of Global BioPharm Center of Excellence
MilliporeSigma, Burlington, MA
A business of Merck KGaA, Darmstadt, Germany
Geoffrey Rule, PhD
Principal Scientist
MilliporeSigma, Bellefonte, PA
A business of Merck KGaA, Darmstadt, Germany
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| January/February 2022
80
VENDOR VIEWPOINTS
78
Data Integrity in the QC Lab - Reducing the Potential for
Human Error in Endotoxin Testing
Hayden Skalski, Lead Global Product Application Specialist,
SUEZ - Water Technologies & Solutions
FDA Withdrawal of Temporary COVID-19 Pandemic
Hand Sanitizer Manufacturing Guidelines; Additional
Testing May Be Required
Russell Griggs, MS,
CCRC
Margaret Butler, PhD
BioScience Laboratories, a Nelson Labs company
REGULAR FEATURES
6
7
82
84
P.I.N. Points
Advertiser's Index
Message from the Editor
Editorial Advisory Board
http://40
APR January/February 2022

Table of Contents for the Digital Edition of APR January/February 2022
