2 BioPharm International
®
Manufacturing and Facilities 2022 eBook www.biopharminternational.com
BioPharm
I N T E R N AT I O N A L
eBook
T h e S ci e n ce & B usi n e ss o f B i o p h a r m a ce u t i c a ls
Contents
Cover: cherezoff - stock.adobe.com
AUTOMATION
From Design to Qualification: Creating
the Most Efficient Single-Use Facilities
Ryan Campbell and Kevin Schreier 4
Smoothing the Path to Pharma 4.0:
Challenges and Solutions
Nicola Gardner 8
OPERATIONS
Machine Learning and Data
Analysis for Optimal Productivity
of Pharmaceutical Water Systems
Chris Robinson and Jason Robes 12
How Integrated Project Delivery
Enables Speed: A Phase-By-Phase Guide
Christian Goesker, Thomas Lederer, and Mike Barrett 18
CLEANROOMS
Threading the Needle
Between DIY and CDMO
Ravi Samavedam 22
AUDITS AND INSPECTIONS
A Harmonized Approach to Performing a
Risk-Based Audit Trail Review
Julie Lippke, Joseph Mongillo, Thomas Cullen, Christian Metz,
Katria Harasewych, and Fouad Benamira 24
OUTSOURCING
Exploring Options for
Optimizing Cell Line Development
Jason Martin 30
Choosing the Right
CDMO for CGT Programs
Brian Mullan 33
AD INDEX 36
Manufacturing and
Facilities 2022
FOUNDER
Mike Hennessy Sr
1960 - 2021
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ADVERTISING
Publisher Mike Tracey MTracey@mjhlifesciences.com
National Sales Manager Scott Vail SVail@mjhlifesciences.com
European Sales Manager Linda Hewitt LHewitt@mjhlifesciences.com
European Senior Sales Executive
Stephen Cleland SCleland@mjhlifesciences.com
Executive Vice President, Healthcare and Industry Sciences
Brian Haug BHaug@mmhgroup.com
AUDIENCE DEVELOPMENT
Audience Development Stacy Argondizzo SArgondizzo@mjhlifesciences.com
MJH LIFE SCIENCES
TM
President & CEO Mike Hennessy Jr
Chief Financial Officer Neil Glasser, CPA/CFE
Chief Operating Officer Michael Ball
Chief Marketing Officer Brett Melillo
Executive Vice President,
Global Medical Affairs & Corporate Development Joe Petroziello
Senior Vice President, Content Silas Inman
Vice President, Human Resources and Administration Shari Lundenberg
Vice President, Mergers & Acquisitions Phil Talamo
Executive Creative Director Jeff Brown
EDITORIAL
Editorial Director Chris Spivey CSpivey@mjhlifesciences.com
Senior Editor Felicity Thomas FThomas@mjhlifesciences.com
Senior Editor Meg Rivers MRivers@mjhlifesciences.com
Managing Editor Susan Haigney SHaigney@mjhlifesciences.com
Science Editor Feliza Mirasol FMirasol@mjhlifesciences.com
Assistant Editor Grant Playter GPlayter@mjhlifesciences.com
Assistant Editor Alivia Leon ALeon@mjhlifesciences.com
Contributing editors: Jill Wechsler, Cynthia A. Challener, Jennifer Markarian
Creative Director, Publishing Melissa Feinen
Senior Art Director Marie Maresco
Senior Graphic Designer Maria Xelo
CUSTOM CONTENT
Vice President Colleen Hall
Director Robert Alaburda
Managing Editor Jeanne Linke Northrop
Senior Editor Megan Manzano
Senior Editor Shannon Stolz
Writer Alissa Marripodi
