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American Pharmaceutical American Pharmaceutical The Review of American Pharmaceutical Business & Technology Volume 23 Issue 5 | July/August 2020 SHOW ISSUE: 15th Annual PDA Global Conference on Pharmaceutical Microbiology - Virtual Microbiological Attributes, Speci cations, and Risk Assessment of Culture-Based erapeutic Products Quantitative NMR in Biotherapeutic Drug Development Modeling the E ects of Supply Chain and Operator Disruptions on Cell erapy Manufacturing Facility Operations During the COVID-19 Pandemic Microbiology Roundtable www.americanpharmaceuticalreview.com Simplifying Progress Biomanufacturing has to innovate. To ultimately make new therapeutics more affordable for patients. Sartorius is part of the solution. With technologies to accelerate process development and to manufacture biologics more efficiently. sartorius.com/simplifying-progress CONTRACT MANUFACTURING Biologics | Aseptic Fill Finish | Drug Product | Potent Hot Melt Extrusion | Fermentation | ADCs | APIs abbviecontractmfg.com Experience Unrivaled Aseptic Fill Finish Enable your product to commercial success by leveraging our pharmaceutical and CMO expertise. American Pharmaceutical Review POSTMASTER: Send change of addresses to Published by American Pharmaceutical Review, 395 Oyster Point Blvd. #300, South San Francisco, CA 94080. Publication Agreement #40739004. CompareNetworks, Inc. Return undeliverable Canadian addresses to: Editorial 395 Oyster Point Blvd. #300 IMEX, PO Box 25542, London, ON N6C 6B2, Canada, EDITOR-IN-CHIEF | Mike Auerbach South San Francisco, CA 94080 [email protected] Email: [email protected] WEB CONTENT EDITOR | Andrea Lyn Van Benschoten www.comparenetworks.com [email protected] E-mail: [email protected] Copyright rests with the publishers. Website: www.americanpharmaceuticalreview.com Sales All rights reserved ©2020 NATIONAL SALES MANAGER | Laura Zoibi Rice Printed in the USA CompareNetworks, Inc. [email protected] Production No part of this publication may be reproduced, stored in a retrieval ART DIRECTOR | Jennifer Campbell system or transmitted in any form or by any means electronic, [email protected] mechanical, photocopying, recording or otherwise without the prior PRODUCTION MANAGER | Allison Chelminiak [email protected] American Pharmaceutical Review (ISSN 1099-8012) is published written permission of the copyright holder. 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ACCOUNT COORDINATOR | Dorothy Fuentes Periodicals postage paid at South San Francisco, CA 94080 and any reader as a result of any advertisement, editorial, photographs or additional mailing offi ces. other material published in American Pharmaceutical Review. ns lutio So ne li In d e t a m o t u A Global Leaders of Container Closure Integrity Test Equipment Drug safety & quality starts with insuring HVLD nt Container Closure Integrity re ur C o r ic M n a c S COMPLETE CCI SOLUTIONS PROVIDER FOR NEW VACCINES - E • CCI test equipment – offline and automated inline solutions • Test method consulting and support • System validation • 21 CFR part 11 compliance • Backed by 35+ years of CCI expertise and experience PTI - Packaging Technologies and Inspection 914.337.2005 | www.ptiusa.com | Hawthorne, New York July/August 2020 2 | | July/August 2020 | Volume 23, Issue 5 COVER FEATURES 10 MICROBIOLOGY Microbiological Attributes, Specifications, and Risk Assessment of Culture-Based Therapeutic Products Tony Cundell, PhD Principal Consultant Microbiological Consulting, LLC 36 SPECTROSCOPY Quantitative NMR in Biotherapeutic Drug Development: An Efficient General-Purpose Tool for Process Analytics Gennady Khirich & Ken Skidmore Analytical Operations Genentech 44 MANUFACTURING Modeling the Effects of Supply Chain and Operator Disruptions on Cell Therapy Manufacturing Facility Operations During the COVID-19 Pandemic Kan Wang,1 Yi Liu,1,2 Junxuan Li,3 Chip White,1 Ben Wang,1 Bruce L. Levine4 1Georgia Tech Manufacturing Institute, Georgia Institute of Technology, Atlanta, GA 2School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, GA 3H. Milton Stewart School of Industrial and Systems Engineering, Georgia Institute of Technology, Atlanta, GA 4Center for Cellular Immunotherapies and Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 60 MICROBIOLOGY ROUNDTABLE Microbiology Roundtable www.americanpharmaceuticalreview.com | | 3 IN THIS ISSUE » 18 MICROBIOLOGY 92 SPECTROSCOPY Functional Challenges for Alternative Bacterial Endotoxins Tests Applying Microfluidic Modulation Spectroscopy in Vaccine Formulation to Part 2: Comparability Identify Intermolecular Beta-sheet Aggregation of Antigens James Akers,1 Dennis E. Guilfoyle,2 David Hussong,3 Karen McCullough,4 Patrick L. Ahl,1 Garrett Baird,2 Christopher Farrell,1 William J. Smith,1 Jeffrey Blue,1 3 Robert Mello,5 Donald Singer,6 Edward Tidswell,7 and Radhakrishna Tirumalai8 and Libo Wang 1 1Akers Kennedy Associates, Inc., Leawood, KS Merck & Co., Inc., MRL, West Point, PA 2 2Johnson and Johnson, New Brunswick, NJ Merck & Co., Inc., MMD, West Point, PA 3 3Eagle Analytical, Houston, TX RedShift BioAnalytics Inc., Burlington, MA 4MMI Associates, Whitehouse Station, NJ 96 BIOPHARMACEUTICAL PROCESSING 5Mello PharmAssociates, LLC, Reisterstown, MD 6Ecolab Life Sciences, St. Paul, MN What Does Digitalization Really Mean to Drug Substance Manufacturing? 7Merck & Co, West Point, PA A Case Study 8North Potomac, MD Bonnie K. Shum Senior Engineer (PT Innovation and MSAT, Technology Acceleration Team) 28 BIOPHARMACEUTICAL DEVELOPMENT Genentech, Inc., A member of the Roche Group Opportunities and Pitfalls in the Analysis of Subvisible Particles during 104 VENDOR VIEWPOINT Biologics Product Development and Quality Control LAL and rFC Comparison Study Caveats Danny K. Chou, PharmD, PhD, President, Compassion BioSolution, LLC Kevin Williams Mark Bumiller, Technology Manager, Entegris, Inc. Biomerieux 48 DRUG DEVELOPMENT 114 VENDOR VIEWPOINT Orchestrating the Digital Cell and Gene Therapy Treatment Journey Around Process Analytical Technology and Real-Time TOC Testing of Pharmaceutical the Patient Grade Water Systems Josh Fyffe, Omkar Kawalekar, Hussain Mooraj Michelle Neumeyer Deloitte Consulting LLP Life Sciences Product Applications Specialist for the Sievers line of Analytical instruments SUEZ – Water Technologies & Solutions 54 SPECTROSCOPY Paving the Way for Real Time Process Monitoring in Biomanufacturing SPECIAL FEATURES Dhanuka P. Wasalathanthri, Matthew S. Rehmann, Jay M. West, Michael C. Borys, 8 CNPerspectives Julia Ding, and Zhen Jian Li 9 Social Media Connections Global Product Development & Supply 34 QC Corner with MilliporeSigma Bristol Myers Squibb Company 82 2020 INTERPHEX Award Winners 76 MANUFACTURING 84 An Interview with Lonza Pharma & Biotech Pfizer Case Studies Leveraging Multivariate Analysis for Initial Diagnostics 100 Sponsored Content by Lonza Pharma & Biotech and Process Understanding 112 Equipment Focus José-Miguel Montenegro-Alvarado, Manager, Process Analytical Technology Projects Global Technology & Engineering / Process Monitoring, Automation & Control 116 Editor's Top Tech Pfizer REGULAR FEATURES 86 MANUFACTURING 6 Message from the Editor Impact of COVID-19 on Manufacturing of Cell and Gene Therapy and Biotech Products, and Overall Clinical Trial Landscape 7 Editorial Advisory Board Mo Heidaran, Heath Coats, Kurt Brorson and Steve Winitsky 118 P.I.N. Points Parexel International 120 Advertiser's Index July/August 2020 4 | | DOING OUR PART... TO ENSURE A HEALTHY WORLD Pursuing Sustainability Excellence Since 2011, Associates of Cape Cod, Inc., has had a growing commitment to taking a responsible role in making sure we do our part to ensure that we reduce the environmental footprint on our operations. We endeavor to work with partners and suppliers who share common goals and contributions to collectively operate in a sustainable manner to benefit the environment. Associates of Cape Cod, Inc. Your Endotoxin & Glucan Experts www.acciusa.com • 888.395.2221 MKT20-046 » Message from the Editor » Th ere (Should be a Better) App for Th at Way back in 2009, before this pandemic, before murder hornets, before everything else 2020 has thrown at us – Apple introduced its iPhone 3G. It truly seems like an eon ago, especially since Apple is now selling the iPhone 11, but back then the 3G was a big deal, and Apple put together a very extensive advertising and marketing program to support the 3G. One of the most popular ads was the famous “There’s an app for that” commercial. Basically, this commercial promoted the fact that the 3G could run any of the numerous apps that were available at the time. From recipes, to directions, to counting calories – “There’s an app for that” was the tagline. The ad and in particular the tagline became so popular that Apple actually trademarked the phrase in 2010. Who knew? The phrase has also infi ltrated our regular conversations – being used as a catch-all whenever someone mentions they
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