BioPharm International - November 2022

BioPharm International - November 2022

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2 BioPharm International ® Manufacturing and Facilities 2022 eBook 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 - 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 © 2022 MultiMedia Pharma Sciences LLC All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording, or information storage and retrieval without permission in writing from the publisher. Authorization to photocopy items for internal/educational or personal use, or the internal/educational or personal use of specific clients is granted by MultiMedia Pharma Sciences LLC for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750- 8400 fax 978-646-8700 or visit online. For uses beyond those listed above, please direct your written request to with "Permissions" in the subject line. Reprints: Contact Michael Tracey, MultiMedia Pharma Sciences LLC provides certain customer contact data (such as customers' names, addresses, phone numbers, and e-mail addresses) to third parties who wish to promote relevant products, services, and other opportunities that may be of interest to you. If you do not want MultiMedia Pharma Sciences LLC to make your contact information available to third parties for marketing purposes, simply email and a customer ser vice represent ative will assist you in removing your name from MultiMedia Pharma Sciences LLC lists. BioPharm International does not verif y any claims or other information appearing in any of the adver tisements contained in the publication, and cannot take responsibilit y for any losses or other damages incurred by readers in reliance of such content. BioPharm International welcomes unsolicited articles, manuscripts, photographs, illustrations, and other materials but cannot be held responsible for their safekeeping or return. To subscribe, email ADVERTISING Publisher Mike Tracey National Sales Manager Scott Vail European Sales Manager Linda Hewitt European Senior Sales Executive Stephen Cleland Executive Vice President, Healthcare and Industry Sciences Brian Haug AUDIENCE DEVELOPMENT Audience Development Stacy Argondizzo 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 Senior Editor Felicity Thomas Senior Editor Meg Rivers Managing Editor Susan Haigney Science Editor Feliza Mirasol Assistant Editor Grant Playter Assistant Editor Alivia Leon 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

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