BioPharm International - November 2024

BioPharm International - November 2024

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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 FOUNDER Mike Hennessy Sr 1960 - 2021 © 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 BPpress@ mmhgroup.com with "Permissions" in the subject line. Reprints: Contact Brian Haug, Bhaug@mmhgroup.com. 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 mmhinfo@ mmhgroup.com and a customer service representative will assist you in removing your name from MultiMedia Pharma Sciences LLC lists. BioPharm International ® 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. BioPharm International welcomes unsolicited articles, manuscripts, photographs, illustrations, and other materials but cannot be held responsible for their safekeeping or return. To subscribe, email mmhinfo@mmhgroup.com Contents EDITORIAL Vice President, Content Alicia Bigica ABigica@mjhlifesciences.com Associate Editorial Director Felicity Thomas FThomas@mjhlifesciences.com Lead Editor Susan Haigney SHaigney@mjhlifesciences.com Science Editor Feliza Mirasol FMirasol@mjhlifesciences.com Editor Patrick Lavery PLavery@mjhlifesciences.com Contributing editors Cynthia A. Challener Design and Production Creative Director Robert McGarr rmcgarr@mjhlifesciences.com Senior Art Director Kristen Morabito kmorabito@mjhlifesciences.com Print and Circulation Director Jonathan Severn jsevern@mjhassoc.com Production Manager Charlton Prince cprince@mjhlifesciences.com Print Production Coordinator Amber Immordino ammordino@mjhassoc.com CUSTOM CONTENT Director Robert Alaburda Managing Editor Jeanne Linke Northrop Senior Editor Megan Manzano Senior Editor Shannon Stolz ADVERTISING National Sales Manager Scott Vail SVail@mjhlifesciences.com Sales Manager Joel Kern JKern@mjhlifesciences.com European Sales Manager Linda Hewitt LHewitt@mjhlifesciences.com European Senior Sales Executive Stephen Cleland SCleland@mjhlifesciences.com Director, Industry Relations and Strategic Partnerships Chris Spivey CSpivey@mjhlifesciences.com MJH LIFE SCIENCES ® President & CEO Mike Hennessy Jr Chief Financial Officer Neil Glasser, CPA/CFE Chief Operating Officer Beth Buehler Chief Data Officer Terric Townsend Executive Vice President, Global Medical Affairs & 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 Manufacturing and Facilities eBook November 2024 Cover: Bos Amico – Stock.Adobe.com BIOPROCESSING A Step Closer to Closure in Bioprocessing Sarah Le Merdy and Christophe Dufossé As biopharma anticipates the "Facility of the Future," a definition of what closed processing is, and quantification of its value, can be helpful information. 4 MANUFACTURING The Patient-Centric Manufacturing Model Susan Haigney Jason Bock, co-founder and CEO of CTMC, discusses the industry impact and manufacture of patient-centered medicines. 11 OUTSOURCING How Modularization and Digital Delivery are Transforming Pharma Manufacturing Jordan Ulrich and Dana Tilley Modular and replication strategies are being utilized to meet growing demand for CDMO facilities. 14 FACILITIES Quality Pitfalls of Aging Facilities and Equipment Susan Haigney Operating in an aging facility and/or utilizing outdated equipment may lead to drug shortages and high operating costs. 18 ANALYTICS Extracellular Vesicles and Fluorescence Excitation-Emission Matrix Spectroscopy Lyufei Chen Fluorescence spectroscopy offers unique advantages for characterizing EVs. 22 AD INDEX 26 www.biopharminternational.com Manufacturing and Facilities eBook November 2024 BioPharm International ® 3

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