Pharmaceutical Technology - April 2024

Pharmaceutical Technology - April 2024

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PharmTech.com Innovations in mRNA eBook April 2024 Pharmaceutical Technology ® 3 © 2024 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 Brian Haug, bhaug@mmhgroup.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 Innovations in mRNA eBook April 2024 EDITORIAL Vice President, Content Alicia Bigica ABigica@mjhlifesciences.com Senior Editor Felicity Thomas FThomas@mjhlifesciences.com Lead Editor Susan Haigney SHaigney@mjhlifesciences.com Science Editor Feliza Mirasol FMirasol@mjhlifesciences.com Assistant Editor Daria Husni DHusni@mjhlifesciences.com CONTRIBUTING EDITORS Hallie Forcinio, editorhal@cs.com Cynthia A. Challener, PhD, challener@vtlink.net Design and Production Creative Director, Robert McGarr Senior Art Director Kristen Morabito Senior Graphic Designer Chrissy Bolton Print and Circulation Director Jonathan Severn Production Manager Charlton Prince Print Production Coordinator Alexandra Rivera CUSTOM CONTENT Director Robert Alaburda Managing Editor Jeanne Linke Northrop Senior Editor Megan Manzano Senior Editor Shannon Stolz SALES 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 Director, Industry Relations and Strategic Partnerships Chris Spivey CSpivey@mjhlifesciences.com Address 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA Tel. 732.596.0276, Fax 732.647.1235 PharmTech.com CORPORATE President & CEO Mike Hennessy Jr Chief Financial Of ficer Neil Glasser, CPA/CFE Chief Operating Of ficer Beth Buehler Chief Data Of ficer Terric Townsend Executive Vice President, Global Medical Af fairs & Corporate Development Joe Petroziello Executive Vice President, Healthcare Brian Haug Senior Vice President, Content Silas Inman Senior Vice President, Human Resources & Administration Shari Lundenberg Senior Vice President, Mergers & Acquisitions, Strategic Innovation Phil Talamo Executive Creative Director Jeff Brown FORMULATION 4 Evaluating the Partnership Between mRNA and LNPs Feliza Mirasol MANUFACTURING 8 Increasing mRNA Product Stability with Lyophilization Cynthia A. Challener UPSTREAM PROCESSING 13 The Making of mRNA Chris Spivey REGULATIONS 17 Navigating an Uncertain Regulatory Environment for mRNA-based Products Michele Duggan 19 Ad Index COVER IMAGE: XYZ+ - STOCK.ADOBE.COM e B O O K S E R I E S A P R I L 2 0 2 4 INNOVATIONS IN mRNA Formulation Upstream Processing Manufacturing Regulations

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