Pharmaceutical Technology - April 2023

Pharmaceutical Technology- April 2023

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2 Pharmaceutical Technology ® The Real Message Behind Commercial mRNA Products April eBook 2023 PharmTech.com FROM THE EDITOR 4 The mRNA Message Chris Spivey mRNA TRENDS 6 Learning to Think at Lightspeed Chris Spivey 12 Nucleic Acid-based Therapeutics Are Stepping into the Spotlight Feliza Mirasol DEVELOPMENT 18 COVID-19's Impact on RNA Drug Development Marina Necdina 22 Excipients Impact Stability in mRNA-LNP Formulations Cynthia A. Challener DRUG DELIVERY 26 Delivering on the Potential of mRNA Therapeutics David Ricketts, Nevin Witman, Phil Challis, Senne Dillen, and Bernard Sagaert ANALYTICS 36 The Marriage of RNA and Mass Spectrometry Mark Rogers 40 The Role of Separation Techniques in the Analysis of mRNA Therapeutic Drug Substances and Drug Products Christina Vanhinsbergh STABILITY 50 Managing mRNA Instability During Formulation, Manufacturing, and Shipment Cynthia A. Challener 52 Ad Index Cover image: myboys.me - stock.adobe.com; Cover design, Maria Xelo The Real Message Behind Commercial mRNA Products April 2023 © 2023 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 http://www.copyright.com online. For uses beyond those listed above, please direct your written request to PTpress@mmhgroup.com with "Permissions Department" in the subject line. MultiMedia Pharma Sciences LLC provides certain customer contact data (such as customers name, addresses, phone num- bers, 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 mmhinfo@mmhgroup.com and a customer service representative will assist you in removing your name from MultiMedia Pharma Sciences LLC lists. Pharmaceutical Technology does not verify any claims or other information appearing in any of the advertisements contained in the publication, and cannot take responsibility for any losses or other damages incurred by readers in reliance of such content. Pharmaceutical Technology welcomes unsolicited articles, manuscripts, photographs, illustrations, and other materials but cannot be held responsible for their safekeeping or return. Reprints: Contact Mike Tracey, mtracey@mjhlifesciences.com. Display, Web, Classified, and Recruitment Advertising: Contact, tel. 732.346.3027. To subscribe: mmhinfo@mmhgroup.com F O U N D E R Mike Hennessy Sr 1 9 6 0 - 2 0 2 1 EDITORIAL Editorial Director Chris Spivey CSpivey@mjhlifesciences.com Senior Editor Felicity Thomas FThomas@mjhlifesciences.com Managing Editor Susan Haigney SHaigney@mjhlifesciences.com Science Editor Feliza Mirasol FMirasol@mjhlifesciences.com Editor Jill Murphy JMurphy@mjhlifesciences.com Associate Editor Grant Playter GPlayter@mjhlifesciences.com Assistant Editor Alivia Leon ALeon@mjhlifesciences.com Creative Director, Publishing Melissa Feinen Senior Art Director Marie Maresco; Senior Graphic Designer Maria Xelo CONTRIBUTING EDITORS: Jill Wechsler jillwechsler7@gmail.com; Hallie Forcinio, editorhal@cs.com; Susan J. Schniepp, sue.schniepp@mac.com; Cynthia A. Challener, PhD challener@vtlink.net ; and Jennifer Markarian, Manufacturing Reporter. CUSTOM CONTENT: Vice President, Content and Special Projects Colleen Hall; Director Robert Alaburda; Managing Editor Jeanne Linke Northrop; Senior Editor Megan Manzano; Senior Editor Shannon Stolz; Writer Alissa Marripodi SALES Publisher Mike Tracey MTracey@mjhlifesciences.com East Coast Sales Manager Joel Kern JKern@mjhlifesciences.com Mid West, West Coast Sales Manager BJ Ghiglione BGhiglione@mjhlifesciences.com Associate Publisher of Pharmaceutical Technology Europe Linda Hewitt LHewitt@mjhlifesciences.com European Sales Manager Stephen Cleland SCleland@mjhlifesciences.com Vice President, Pharmaceutical Sciences Todd Baker TBaker@mjhlifesciences.com Executive Vice President, Healthcare and Industry Sciences Brian Haug BHaug@mmhgroup.com ADDRESS 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA Tel. 732.596.0276, Fax 732.647.1235 PharmTech.com MJH LIFE SCIENCES ® President & CEO Mike Hennessy Jr Chief Financial Officer Neil Glasser, CPA/CFE Chief Operating Officer Michael Ball Chief Marketing Officer Brett Melillo Chief Data Officer Terric Townsend 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

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