BioPharm International - July 2021

BioPharm - July 2021 - Biopharmaceutical Analysis

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2 BioPharm International eBook July 2021 © 2021 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 Permission Dept. Alexa Rockenstein, 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 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 ADVERTISING Publisher Mike Tracey National Sales Manager Scott Vail European Sales Manager Linda Hewitt European Senior Sales Executive Stephen Cleland Senior Vice President, Industry Sciences Michael Tessalone C.A.S.T. Data and List Information Michael Kushner AUDIENCE DEVELOPMENT Audience Development Christine Shappell MJH LIFE SCIENCES TM Chairman and Founder Mike Hennessy, Sr Vice Chairman Jack Lepping President and CEO Mike Hennessy, Jr Chief Financial Officer Neil Glasser, CPA/CFE Chief Marketing Officer Michael Baer Executive Vice President, Global Medical Affairs and Corporate Development Joe Petroziello Senior Vice President, Content Silas Inman Senior Vice President, Operations Michael Ball Vice President, Human Resources & Administration Shari Lundenberg Vice President, Mergers & Acquisitions Chris Hennessy Executive Creative Director, Creative Services Jeff Brown EDITORIAL Editorial Director Rita Peters Senior Editor Meg Rivers Managing Editor Susan Haigney European Editor Felicity Thomas Science Editor Feliza Mirasol Manufacturing Editor Jennifer Markarian Creative Director, Publishing Melissa Feinen Senior Art Director Marie Maresco Senior Graphic Designer Maria Reyes 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 Biopharmaceutical Analysis 2021 ANALYTICAL EVOLUTION Complex Biomolecules Require Analytical Evolution Feliza Mirasol 4 METHOD VALIDATION Best Practices for Analytical Method Validation: Study Design, Analysis, and Acceptance Criteria Thomas A. Little 10 DATA INTEGRITY Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing Thomas Cullen, Cliff Mitchell, Julie Lippke, Joseph Mongillo, Koottala S. Ramaswamy, and Thomas Purdue 15 IMPURITY ANALYSIS Detecting Residual HCPs Demands a Holistic Approach Olaf Stamm, Andrew Hanneman, Art Cansizoglu, and Thorsten Strahl 20 Increasing the Depth and Reliability of HCP Analysis Using TIMS-MS Stuart Pengelley 26 PROTEIN CHARACTERIZATION Improving IR Spectroscopy as a Tool for Biopharmaceutical Analysis Holly Lombardo and Matthew McGann 31 CLEANING VALIDATION Prioritizing Cleaning Validation Agnes Shanley 35 Ad Index 37 Cover: mnimpres -

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