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Managing Biomanufacturing Capacity Expectations Randi Hernandez Volume 29 Number 7 BioPharm International INTERNATIONAL BioJuly 2016 PharmThe Science & Business of Biopharmaceuticals JULY 2016 JULY www.biopharminternational.com Single-Use Systems MANAGING I Cleanroom Standards I Raw Materials Materials Raw I Standards Cleanroom I BIOMANUFACTURING CAPACITY EXPECTATIONS Volume 29 Number 7 Number 29 Volume QUALITY PEER-REVIEWED ANALYTICAL TESTING MICROBIOLOGICAL BIOPROCESSING TECHNOLOGY FORCED DEGRADATION TESTING: TIME IS TRENDS OF RNA-BASED STUDIES FOR OF THE ESSENCE THERAPEUTICS AND VACCINES BIOPHARMACEUTICALS HARVEST YOUR DISCOVERY The Biological Process Development Facility has the expertise and flexibility to transfer your discovery to large-scale GMP manufacturing. Let our decades of experience and comprehensive strategies help realize your product’s potential. • Master and working cell banks • Upstream and downstream process development • Microbial manufacture of API and other biologics • Analytical method development and qualification • Quality control and stability testing services • Regulatory Support Learn more at • bpdf.unl.edu • [email protected] • 402.472.1983 magentablackcyanyellow ES808007_BP0716_CV2_FP.pgs 07.05.2016 19:40 ADV INTERNATIONAL BioPharmThe Science & Business of Biopharmaceuticals EDITORIAL EDITORIAL ADVISORY BOARD Editorial Director Rita Peters [email protected] BioPharm International’s Editorial Advisory Board comprises distinguished specialists involved in the biologic manufacture of therapeutic drugs, Senior Editor Agnes Shanley [email protected] diagnostics, and vaccines. Members serve as a sounding board for the Managing Editor Susan Haigney [email protected] editors and advise them on biotechnology trends, identify potential authors, and review manuscripts submitted for publication. Science Editor Randi Hernandez [email protected] Science Editor Adeline Siew, PhD [email protected] K. A. Ajit-Simh Jerold Martin Community Manager Caroline Hroncich [email protected] President, Shiba Associates Independent Consultant Art Director Dan Ward [email protected] Rory Budihandojo Hans-Peter Meyer Contributing Editors Jill Wechsler, Jim Miller, Eric Langer, Director, Quality and EHS Audit Lecturer, University of Applied Sciences Anurag Rathore, Jerold Martin, Simon Chalk, Boehringer-Ingelheim and Arts Western Switzerland, and Institute of Life Technologies. Cynthia A. Challener, PhD Edward G. Calamai Correspondent Sean Milmo (Europe, [email protected]) Managing Partner K. John Morrow Pharmaceutical Manufacturing President, Newport Biotech and Compliance Associates, LLC ADVERTISING David Radspinner Suggy S. Chrai Publisher Mike Tracey [email protected] Global Head of Sales—Bioproduction President and CEO Thermo Fisher Scientific National Sales Manager Steve Hermer [email protected] The Chrai Associates East Coast Sales Manager Scott Vail [email protected] Tom Ransohoff Leonard J. Goren Vice-President and Senior Consultant European Sales Manager Linda Hewitt [email protected] Global Leader, Human Identity BioProcess Technology Consultants C.A.S.T Data and List Information Division, GE Healthcare Ronda Hughes [email protected] Uwe Gottschalk Anurag Rathore Biotech CMC Consultant Reprints 877-652-5295 ext. 121/ [email protected] Vice-President, Faculty Member, Indian Institute of Outside US, UK, direct dial: 281-419-5725. Ext. 121 Chief Technology Officer, Pharma/Biotech Technology Lonza AG PRODUCTION Susan J. Schniepp Fiona M. Greer Fellow Production Manager Jesse Singer [email protected] Global Director, Regulatory Compliance Associates, Inc. BioPharma Services Development AUDIENCE DEVELOPMENT SGS Life Science Services Tim Schofield Senior Fellow Audience Development Rochelle Ballou [email protected] Rajesh K. Gupta MedImmune LLC Vaccinnologist and Microbiologist Paula Shadle Jean F. Huxsoll Principal Consultant, Senior Director, Quality Shadle Consulting Product Supply Biotech Bayer Healthcare Pharmaceuticals © 2016 UBM. All rights reserved. No part of this publication may be reproduced Alexander F. Sito or transmitted in any form or by any means, electronic or mechanical including President, by photocopy, recording, or information storage and retrieval without permission Denny Kraichely BioValidation in writing from the publisher. Authorization to photocopy items for internal/ Associate Director educational or personal use, or the internal/educational or personal use of Johnson & Johnson Michiel E. Ultee specific clients is granted by UBM for libraries and other users registered with the Principal Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 Stephan O. Krause Ulteemit BioConsulting fax 978-646-8700 or visit http://www.copyright.com online. For uses beyond Director of QA Technology those listed above, please direct your written request to Permission Dept. fax 440- AstraZeneca Biologics 756-5255 or email: [email protected]. Thomas J. Vanden Boom Steven S. Kuwahara VP, Biosimilars Pharmaceutical Sciences UBM Americas provides certain customer contact data (such as customers’ Pfizer names, addresses, phone numbers, and e-mail addresses) to third parties who Principal Consultant GXP BioTechnology LLC wish to promote relevant products, services, and other opportunities that may Krish Venkat be of interest to you. If you do not want UBM Americas to make your contact information available to third parties for marketing purposes, simply call toll-free Eric S. Langer Managing Partner 866-529-2922 between the hours of 7:30 a.m. and 5 p.m. CST and a customer President and Managing Partner Anven Research service representative will assist you in removing your name from UBM Life BioPlan Associates, Inc. Sciences’ lists. Outside the U.S., please phone 218-740-6477. Steven Walfish Principal Scientific Liaison BioPharm International does not verify any claims or other information Howard L. Levine appearing in any of the advertisements contained in the publication, and cannot President USP take responsibility for any losses or other damages incurred by readers in reliance BioProcess Technology Consultants of such content. Gary Walsh Herb Lutz Professor BioPharm International welcomes unsolicited articles, manuscripts, Principal Consulting Engineer Department of Chemical and photographs, illustrations, and other materials but cannot be held responsible for Merck Millipore Environmental Sciences and Materials their safekeeping or return. and Surface Science Institute To subscribe, call toll-free 888-527-7008. Outside the U.S. call 218-740-6477. University of Limerick, Ireland INTERNATIONAL BioPharm International integrates the science and business of BioPharm biopharmaceutical research, development, and manufacturing. We provide practical, Contents peer-reviewed technical solutions Volume 29 Number 7 July 2016 to enable biopharmaceutical professionals to perform their jobs more effectively. FEATURES CAPACITY ANALYTICAL TESTING CLEANROOM STANDARDS Managing Biomanufacturing Forced Degradation Studies Revised ISO Cleanroom Capacity Expectations for Biopharmaceuticals Standards Improve Air Randi Hernandez Anette Skammelsen Schmidt Cleanliness Classification Capacity for complex The author addresses critical issues to consider Jennifer Markarian therapeutics is becoming prior to performing forced degradation studies Revised versions of ISO 14644 Parts increasingly difficult to predict. 14 and provides best practice recommendations 1 and 2 introduce changes to sampling for these types of studies. 24 procedures and monitoring plans for cleanrooms and clean zones. 38 QUALITY Microbiological Testing: PEER-REVIEWED Time is of the Essence Bioprocessing Technology PACKAGING TRENDS Cynthia A. Challener Trends of RNA-Based Raw Materials Pressures to accelerate Therapeutics and Vaccines Packaging Innovations current and next-gen therapies Claire Scanlan, Priyabrata Pattnaik, for Biopharmaceutical are challenging traditional Ruta Waghmare, Elina Gousseinov, Manufacturing microbiological testing methods. 20 Mikhail Kozlov, Aaron Hammons, Ling Bei, Nandu Deorkar Youssef Benchek, and Karim Pirani Recent trends in raw materials packaging This article reviews the current dynamics may impact manufacturing, quality, in the RNA therapeutics/vaccines market. 30 and cost of biopharmaceuticals. 40 COLUMNS AND DEPARTMENTS 6 From the Editor 44 Troubleshooting CPhI Pharma Awards The author provides a seek nominations for review of the concepts of excellence in biopharma. design and qualification that Rita Peters apply to single-use systems. Jerold M. Martin 8 US Regulatory Beat Volume 29 Number 7 INTERNATIONAL Agency guidance and industry 49 New Technology Showcase BioJuly 2016 PharmThe Science & Business of Biopharmaceuticals standards aim to reduce lapses www.biopharminternational.com and improve quality operations. 49 Product Spotlight MANAGING Jill Wechsler BIOMANUFACTURING 49 Ad Index CAPACITY EXPECTATIONS 12 Perspectives on Outsourcing 50 Biologics News Pipeline CDMOs need to be aware that unfavorable public markets put emerging bio/pharma R&D QUALITY PEER-REVIEWED ANALYTICAL TESTING MICROBIOLOGICAL BIOPROCESSING TECHNOLOGY FORCED DEGRADATION TESTING: TIME IS TRENDS OF RNA-BASED STUDIES FOR spending at risk in 2017. OF THE ESSENCE THERAPEUTICS AND VACCINES BIOPHARMACEUTICALS Jim Miller Cover: JurgaR/Getty Images BioPharm InternationalJTTFMFDUJWFMZBCTUSBDUFEPSJOEFYFEJOrBiological Sciences Database (Cambridge Scientifi c Abstracts)rBiotechnology and Bioengineering Database (Cambridge Scientifi c Abstracts)rBiotechnology
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