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Volume 33 Number 5 BioPharm International INTERNATIONAL BioMay 2020 PharmThe Science & Business of Biopharmaceuticals MAY 2020 MAY www.biopharminternational.com GENE THERAPIES PUSH VIRAL VECTOR PRODUCTION UPSTREAM PROCESSING SYNTHETIC BIOLOGY COVID-19 I Modern Manufacturing I Development Efforts DOWNSTREAM PROCESSING FLUID HANDLING CONSIDERATIONS MANUFACTURING CLOSED FILLING SYSTEMS ANALYTICS BIOASSAY DEVELOPMENT QUALITY/REGULATIONS REMOTE AUTOMATION PRACTICES OUTSOURCING CONTINUOUS BIOPROCESSING PEER-REVIEW RESEARCH IR SPECTROSCOPY FOR BIOCHARACTERIZATION Volume Number 33 5 Whether it’s a vaccine, recombinant protein, or gene therapy, Avantor ® can help transform how these therapies are brought to market, combining our unique workflow expertise with advanced biologic products engineered to satisfy the highest quality standards and regulatory requirements. We help enable breakthroughs in life-changing biologics. avantorsciences.com/moves-biopharma-forward INTERNATIONAL BioPharmThe Science & Business of Biopharmaceuticals ADVERTISING EDITORIAL Publisher Mike Tracey [email protected] Editorial Director Rita Peters [email protected] National Sales Manager Scott Vail [email protected] Senior Editor Agnes M. Shanley [email protected] Managing Editor Susan Haigney [email protected] European Sales Manager Linda Hewitt [email protected] European Editor Felicity Thomas [email protected] European Senior Sales Executive Science Editor Feliza Mirasol [email protected] Stephen Cleland [email protected] Manufacturing Editor Jennifer Markarian [email protected] VP/Managing Director, Pharm/Science Group Dave Esola Assistant Editor Lauren Lavelle [email protected] [email protected] Senior Art Director Marie Maresco C.A.S.T. Data and List Information Graphic Designer Maria Reyes Michael Kushner [email protected] EDITORIAL ADVISORY BOARD AUDIENCE DEVELOPMENT BioPharm International’s Editorial Advisory Board comprises distinguished specialists involved in the biologic manufacture of therapeutic drugs, Audience Development Christine Shappell [email protected] diagnostics, and vaccines. Members serve as a sounding board for the editors and advise them on biotechnology trends, identify potential MJH LIFE SCIENCESTM authors, and review manuscripts submitted for publication. Chairman and Founder Mike Hennessy, Sr K. A. Ajit-Simh Hanns-Christian Mahler Vice Chairman Jack Lepping President, Shiba Associates Head Drug Product Services Lonza AG President and CEO Mike Hennessy, Jr Madhavan Buddha Chief Financial Officer Neil Glasser, CPA/CFE Freelance Consultant Jerold Martin Independent Consultant Executive Vice President, Operations Tom Tolvé Rory Budihandojo Executive Vice President, Global Medical Affairs and Director, Quality and EHS Audit Hans-Peter Meyer Boehringer-Ingelheim Lecturer, University of Applied Sciences Corporate Development Joe Petroziello and Arts Western Switzerland, Senior Vice President, Audience Generation and Edward G. Calamai Institute of Life Technologies Managing Partner Product Fulfillment Joy Puzzo Pharmaceutical Manufacturing K. John Morrow Senior Vice President, Content Silas Inman and Compliance Associates, LLC President, Newport Biotech Senior Vice President, I.T. & Enterprise Systems John Moricone Suggy S. Chrai David Radspinner Vice President, Human Resources & Administration Shari Lundenberg President and CEO GE Healthcare The Chrai Associates Vice President, Business Intelligence Chris Hennessy Tom Ransohoff Leonard J. Goren Vice-President and Senior Consultant Executive Creative Director, Creative Services Jeff Brown Global Leader, Human Identity BioProcess Technology Consultants Division, GE Healthcare Uwe Gottschalk Anurag Rathore Vice-President, Biotech CMC Consultant Chief Technology Officer, Faculty Member, Indian Institute of Pharma/Biotech Technology Lonza AG © 2020 MultiMedia Pharma Sciences LLC All rights reserved. No part of this Susan J. Schniepp publication may be reproduced or transmitted in any form or by any means, electronic Fiona M. Greer Executive Vice President of or mechanical including by photocopy, recording, or information storage and retrieval Global Director, Post-Approval Pharma without permission in writing from the publisher. Authorization to photocopy items BioPharma Services Development and Distinguished Fellow for internal/educational or personal use, or the internal/educational or personal use of SGS Life Science Services Regulatory Compliance Associates, Inc. specific clients is granted by MultiMedia Pharma Sciences LLC for libraries and other Rajesh K. Gupta users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA Tim Schofield 01923, 978-750-8400 fax 978-646-8700 or visit http://www.copyright.com online. Vaccinnologist and Microbiologist Consultant For uses beyond those listed above, please direct your written request to Permission Dept. Alexa Rockenstein, [email protected]. Reprints: Contact Michael Denny Kraichely CMC Sciences, LLC Tracey, [email protected]. Associate Director Johnson & Johnson Paula Shadle MultiMedia Pharma Sciences LLC provides certain customer contact data (such Principal Consultant, as customers’ names, addresses, phone numbers, and e-mail addresses) to third parties Stephan O. Krause Shadle Consulting who wish to promote relevant products, services, and other opportunities that may be of Director of QA Technology interest to you. If you do not want MultiMedia Pharma Sciences LLC to make your contact AstraZeneca Biologics information available to third parties for marketing purposes, simply email mmhinfo@ Alexander F. Sito mjhlifesciences.com and a customer service representative will assist you in removing Steven S. Kuwahara President, your name from MultiMedia Pharma Sciences LLC lists. Principal Consultant BioValidation GXP BioTechnology LLC BioPharm International does not verify any claims or other information appearing in Michiel E. Ultee any of the advertisements contained in the publication, and cannot take responsibility for Eric S. Langer Principal any losses or other damages incurred by readers in reliance of such content. President and Managing Partner Ulteemit BioConsulting BioPharm International welcomes unsolicited articles, manuscripts, photographs, BioPlan Associates, Inc. illustrations, and other materials but cannot be held responsible for their safekeeping or return. Thomas J. Vanden Boom Howard L. Levine VP, Biosimilars Pharmaceutical Sciences To subscribe, email [email protected] President Pfizer BioProcess Technology Consultants Hank Liu Krish Venkat Head of Quality Control Managing Partner Sanofi Pasteur Anven Research Herb Lutz Steven Walfish Principal Consulting Engineer Principal Scientific Liaison Merck Millipore USP Table of Contents Volume 33 Number 5 BioPharm International integrates the science and business of biopharmaceutical research, development, and manufacturing. We provide practical, peer-reviewed technical solutions to enable biopharmaceutical professionals to perform their jobs more effectively. COVER STORY 12 Gene Therapies Push Viral Vector Production Viral vectors show promise as a delivery mechanism for gene therapy, but which virus types are commercially viable? Cover Design by Maria Reyes. Images: Kateryna_Kon - Stock.adobe.com FEATURES COLUMNS AND DEPARTMENTS UPSTREAM PROCESSING PEER-REVIEW RESEARCH FROM THE EDITOR Biopharmaceutical Manufacturing Shaping IR Spectroscopy into Will moving at “warp speed” to develop and the Power of Synthetic Biology a Powerful Tool for Biopharma a vaccine impact efficacy or safety? David McElroy Characterizations Rita Peters. .6 Synthetic biology has advanced the scope Dipanwita Batabyal, Libo Wang, and scale with which biologically derived Jeffrey Zonderman, and Mats Wikström REGULATORY BEAT therapeutics can be developed. �������������22 The authors present experimental Policy makers seek to ensure supplies studies showcasing the performance of of new therapies and to limit shortages. DOWNSTREAM PROCESSING microfluidic modulation spectroscopy in Jill Wechsler ���������������������������������������������8 Fluid Handling Considerations the secondary structure characterization Jennifer Markarian of biopharmaceutical products . .42 CELL THERAPIES PIPELINE . .10 Pumps and other components meet the demands of single-use systems QUALITY/REGULATIONS PRODUCT SPOTLIGHT . .56 in biopharmaceutical downstream Good Automation Practices processing. .28 for Remote Operations AD INDEX . .57 Lauren Lavelle MANUFACTURING Having remote operations in place ASK THE EXPERT Straight Talk on is crucial to maintaining good Having a better understanding Closed Aseptic Systems automation practices. .48 about compliance will be of James Agalloco benefit when looking for a job or The industry’s aversion to risk has OUTSOURCING for furthering one’s career. led to its treating closed aseptic Biomanufacturing: Demand for Siegfried Schmitt �����������������������������������58 processing systems as miniature Continuous Bioprocessing Increasing cleanrooms, resulting in redundant Eric S. Langer and expensive practices. .32 But are innovations sufficient to increase SPONSORED CONTENT adoption? CMOs are demanding better ANALYTICS continuous bioprocessing options. 51 BIOPHARMA INSIGHTS Building Better Bioassays Challenges in Bulk Drug Cynthia A. Challener Substance Management Next-generation therapeutics and Michael
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