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Shoring up Drug Delivery for Pandemic Response Volume 33 Number 7 BioPharm International INTERNATIONAL BioJuly 2020 PharmThe Science & Business of Biopharmaceuticals JULY 2020 JULY www.biopharminternational.com SHORING UP DRUG DELIVERY FOR Remote Audits I Onshoring Drug Manufacturing I Drug Delivery PANDEMIC RESPONSE DEVELOPMENT RNA FOR GENE THERAPIES UPSTREAM PROCESSING BUFFER AND MEDIA PREP DOWNSTREAM PROCESSING RESIDUAL IMPURITY TESTING MANUFACTURING SCALE-OUT FOR CELL THERAPIES ANALYTICS BIOSIMILAR PRODUCT QUALITY MICROBIAL CONTAMINATION QUALITY/REGULATIONS INVESTIGATING ROOT CAUSES OPERATIONS BIOLOGICAL SAFETY CABINETS Volume Number 33 7 OUTSOURCING CMOS/CDMOS STEP UP TO COVID-19 Boost your Host Cell Protein Analytics Help ensure clinical success Antibody Affinity Extraction™ and Mass Spectrometry Services from Cygnus HCP experts. When it comes to outsourcing your critical Host Cell Protein analytical projects, it is essential to work with a dependable partner that has pioneered advanced orthogonal methods and HCP analysis solutions you can trust. Avoid delays in clinical trials due to an unforeseen need to optimize the purification process, adverse patient reactions, poor drug shelf life and reduced drug efficacy. Save time and resources on your journey to a quality drug substance. • Assure that your HCP ELISA is fit for purpose of process monitoring and product lot release • Enrich and identify hitchhiker HCPs and improve MS resolution • Optimize your purification process to remove problematic HCPs • Provide comprehensive HCP characterization data to regulatory agencies With you all the way. cygnustechnologies.com © 2020 Cygnus Technologies. All rights reserved. For research use only. Not intended for animal or human therapeutic or diagnostic use. Cygnus_Ad_AAE-MS_8x10.75-B.indd 1 4/17/20 11:20 AM 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] Senior Vice President, Industry Sciences Michael Tessalone Manufacturing Editor Jennifer Markarian [email protected] Assistant Editor Lauren Lavelle [email protected] [email protected] Creative Director, Publishing Melissa Feinen C.A.S.T. Data and List Information Senior Art Director Marie Maresco Michael Kushner [email protected] Graphic Designer Maria Reyes AUDIENCE DEVELOPMENT EDITORIAL ADVISORY BOARD BioPharm International’s Editorial Advisory Board comprises distinguished Audience Development Christine Shappell [email protected] specialists involved in the biologic manufacture of therapeutic drugs, diagnostics, and vaccines. Members serve as a sounding board for the MJH LIFE SCIENCESTM editors and advise them on biotechnology trends, identify potential Chairman and Founder Mike Hennessy, Sr authors, and review manuscripts submitted for publication. Vice Chairman Jack Lepping K. A. Ajit-Simh Hanns-Christian Mahler President and CEO Mike Hennessy, Jr President, Shiba Associates Head Drug Product Services Lonza AG Chief Financial Officer Neil Glasser, CPA/CFE Madhavan Buddha Freelance Consultant Jerold Martin Executive Vice President, Operations Tom Tolvé Independent Consultant Executive Vice President, Global Medical Affairs and Rory Budihandojo Director, Quality and EHS Audit Hans-Peter Meyer Corporate Development Joe Petroziello Boehringer-Ingelheim Lecturer, University of Applied Sciences Senior Vice President, Audience Generation and and Arts Western Switzerland, Edward G. Calamai Institute of Life Technologies Product Fulfillment Joy Puzzo Managing Partner Senior Vice President, Content Silas Inman Pharmaceutical Manufacturing K. John Morrow and Compliance Associates, LLC President, Newport Biotech Senior Vice President, I.T. & Enterprise Systems John Moricone Vice President, Human Resources & Administration Shari Lundenberg Suggy S. Chrai David Radspinner President and CEO GE Healthcare Vice President, Mergers & Acquisitions Chris Hennessy The Chrai Associates Executive Creative Director, Creative Services Jeff Brown Tom Ransohoff Leonard J. Goren Vice-President and Senior Consultant 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, Lonza AG Technology © 2020 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 Fiona M. Greer Susan J. Schniepp or mechanical including by photocopy, recording, or information storage and retrieval Global Director, Executive Vice President of without permission in writing from the publisher. Authorization to photocopy items BioPharma Services Development Post-Approval Pharma for internal/educational or personal use, or the internal/educational or personal use of SGS Life Science Services and Distinguished Fellow specific clients is granted by MultiMedia Pharma Sciences LLC for libraries and other Regulatory Compliance Associates, Inc. users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA Rajesh K. Gupta 01923, 978-750-8400 fax 978-646-8700 or visit http://www.copyright.com online. For Vaccinnologist and Microbiologist Tim Schofield uses beyond those listed above, please direct your written request to Permission Dept. Alexa Rockenstein, [email protected]. Reprints: Contact Michael Tracey, Denny Kraichely Consultant [email protected]. Associate Director CMC Sciences, LLC Johnson & Johnson MultiMedia Pharma Sciences LLC provides certain customer contact data (such Paula Shadle as customers’ names, addresses, phone numbers, and e-mail addresses) to third parties Stephan O. Krause Principal Consultant, who wish to promote relevant products, services, and other opportunities that may be of Director of QA Technology Shadle Consulting 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 mmhgroup.com and a customer service representative will assist you in removing your Steven S. Kuwahara President, name from MultiMedia Pharma Sciences LLC lists. Principal Consultant BioValidation BioPharm International does not verify any claims or other information appearing in GXP BioTechnology LLC any of the advertisements contained in the publication, and cannot take responsibility for Eric S. Langer Michiel E. Ultee any losses or other damages incurred by readers in reliance of such content. President and Managing Partner Principal BioPharm International welcomes unsolicited articles, manuscripts, photographs, BioPlan Associates, Inc. Ulteemit BioConsulting illustrations, and other materials but cannot be held responsible for their safekeeping or return. Howard L. Levine Thomas J. Vanden Boom To subscribe, email [email protected] Senior Managing Director, BDO VP, Biosimilars Pharmaceutical Sciences National Leader, Pfizer BioProcess Technology Group 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 7 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 8 COVID-19: Shoring Up the Drug Delivery Infrastructure Manufacturers and the US government are investing heavily in traditional and non-traditional forms and materials to ensure supplies of containers and delivery devices for COVID-19 treatments and vaccines. Cover Design by Maria Reyes Images: Mr.Ilkin - Stock.adobe.com FEATURES DEVELOPMENT ANALYTICS OUTSOURCING Can Using RNA Simplify Analytical Assays Determine Contractors Balance Increased Gene Therapy Development? Biosimilar Product Quality Demand During COVID-19 Cynthia A. Challener Feliza Mirasol Susan Haigney RNA is easier to manipulate than DNA but Appropriate analytical assays are needed The COVID-19 pandemic has created challenging to deliver to the right cells. 13 to determine and ensure that biosimilar a rise in demand for R&D and a shift in critical quality parameters are on track. .32 focus for some contract organizations. .43 UPSTREAM PROCESSING Improving mAb Manufacturing Detecting Microbial COLUMNS AND DEPARTMENTS Productivity by Optimizing Buffer Contamination in Bioprocessing and Media Prep Process Flow Feliza Mirasol FROM THE EDITOR Nandu Deorkar and Pranav Vengsarkar Safeguarding against microbial Data and science must guide FDA Innovative approaches, including ready- contamination requires rapid detection in making pressure-filled COVID-19 to-use materials and in-line dilution, and innovative technology. .34 vaccine and therapy approval decisions. can significantly
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