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Building Better Manufacturing Facilities APRIL 2020 Volume 32 Number 4 Building Better Manufacturing Facilities Development Accelerating Vaccine Development Optimizing Drug Delivery Manufacturing HPAPI Tabletting Safety Quality/Regulations Supplier Oversight Analytics Cleaning Validation Operations Cold-Chain Packaging Outsourcing Continuous Bioprocessing Peer-Review Research Identifying Impurity in Topical Gel 9th - 11th September | Philadelphia GL-CM-2000006 AD_04.20 Pharma Technology Europe_CPhI North Philadelphia_LOGOS_03.indd 1 16/3/20 11:39 April 2020 Pharmaceutical Technology Europe is the authoritative Advancing Development & Manufacturing source of peer-reviewed research and expert analyses for scientists, engineers, and managers engaged in process PharmTech.com development, manufacturing, formulation and drug delivery, API synthesis, analytical technology and testing, packaging, IT, outsourcing, and regulatory compliance Cover: nasir1164 - Stock.adobe.com in the pharmaceutical and biotechnology industries. Art direction: Maria Reyes 36 16 9 26 PharmTech.com OPERATIONS Features 29 Packaging Preserves the Cold Chain COVER STORY: MANUFACTURING More sustainable and functional 9 Building Better Manufacturing Facilities cold-chain packaging protects biologics Whether refitting existing spaces or building and other temperature-sensitive drugs. new, the need for quick build times, flexibility, QUALITY/REGULATIONS and production efficiency is driving trends 33 Being Vigilant in Supplier Oversight in bio/pharma facility construction. Risk assessments, audits, and good DEVELOPMENT communication between sponsor and 13 Can Vaccine Development supplier are key elements of supplier oversight. Be Safely Accelerated? OUTSOURCING Biopharma companies responding to the 36 Biomanufacturing: Demand COVID-19 outbreak think accelerating the for Continuous Bioprocessing Increasing development of vaccines is safe. But are innovations sufficient to increase adoption? CMOs are demanding better 16 Delivering the Goods continuous bioprocessing options. The new molecules entering the development pipeline are bringing forth ANALYTICS exciting challenges in drug delivery. 39 Alternative Cleaning Validation Methods for Biologics MANUFACTURING Because conventional cleaning methods 26 Understanding Containment for Tabletting can risk product loss, biopharmaceutical Risk levels should be considered when manufacturers are often reluctant to use designing equipment to enhance operator safety. PDE/ADE limits to validate cleaning processes. Peer-Review Research Columns and Regulars 5 Editor’s Comment 20 Identifying the Structure of an Making Every Effort Unknown Impurity in a Topical Gel 6 European Regulatory Watch This case study highlights analytical instrumentation Learning Lessons in Crisis Management and techniques that were used to identify an unknown impurity detected during routine 41 Ad Index release testing of a topical gel drug product. 42 Ask the Expert Critical Knowledge for Preparing Audits Pharmaceutical Technology Europe APRIL 2020 3 SMA MicroParticle ICS Non-Viable Particle Counters THE NEXT LEVEL OF PARTICLE COUNTING UNMATCHED ENVIRONMENTAL CONTROL STERILE.COM For more information, visit our website at sterile.com/particlecounters VELTEK ASSOCIATES, INC. EDITORIAL ADVISORY BOARD PharmTech Group PharmTech Europe Editorial Director Editor Reinhard Baumfalk Luigi G. Martini Rita Peters Felicity Thomas [email protected] [email protected] Vice-President, R&D Chair of Pharmaceutical Senior Editor Publisher Instrumentation & Control Innovation Agnes Shanley Michael Tracey Sartorius AG King’s College London [email protected] [email protected] Rafael Beerbohm Thomas Menzel Sales Manager Managing Editor Director of Quality Systems Menzel Fluid Solutions AG Susan Haigney Linda Hewitt Tel. +44 (0) 151 705 7603 [email protected] Boehringer Ingelheim GmbH Jim Miller [email protected] Manufacturing Editor Phil Borman, DSc Founder and Former President, Senior Sales Executive Jennifer Markarian Stephen Cleland Director, PharmSource, [email protected] Tel. +44 (0) 151 705 7604 Product Development & Supply A Global Data Company Science Editor [email protected] Medicinal Science & Technology Colin Minchom Feliza Mirasol Sales Operations Executive Pharma R&D [email protected] Barbara Williams GlaxoSmithKline Senior Director [email protected] Pharmaceutical Sciences Assistant Editor Evonne Brennan Lauren Lavelle VP & Managing Director, Shire Pharmaceuticals TM [email protected] MJH Life Sciences International Technical Marketing Dave Esola Manager, Pharmaceutical Clifford S. Mintz Senior Art Director C.A.S.T. Data and List Information Marie Maresco Division, President and Founder Michael Kushner IMCD Ireland BioInsights Graphic Designer [email protected] Maria Reyes Rory Budihandojo Tim Peterson Director, Quality and EHS Audit Transdermal Product Boehringer-Ingelheim Development Leader, Drug MJH Life SciencesTM Vice President, Human Resources Christopher Burgess Delivery Systems Division, 3M Chairman and Founder & Administration Managing Director John Pritchard Mike Hennessy, Sr Shari Lundenberg Burgess Analytical Consultancy Technical Director Vice Chairman Vice President, Business Jack Lepping Intelligence Ryan F. Donnelly Philips Respironics President and CEO Chris Hennessy Professor Thomas Rades Mike Hennessy, Jr Vice President, Marketing Queens University Belfast Professor, Amy Erdman Chief Financial Officer Tim Freeman Research Chair in Formulation Neil Glasser, CPA/CFE Executive Creative Director, Managing Director Design and Drug Delivery, Executive Vice President, Creative Services Freeman Technology University of Copenhagen Operations Jeff Brown Tom Tolvé Filipe Gaspar Rodolfo Romañach Published by Senior Vice President, Content Vice-President, R&D Professor of Chemistry Multimedia UK, LLC Silas Inman Sycamore House, Suite 2 Hovione University of Puerto Rico, Lloyd Drive Puerto Rico Senior Vice President, I.T. & Sharon Grimster Enterprise Systems Cheshire Oaks Cheshire Siegfried Schmitt John Moricone ReNeuron Ch65 9HQ, United Kingdom Vice-President Technical Senior Vice President, Audience Tel. +44 151 705 7601 Anne Marie Healy PAREXEL Generation & Product Fulfillment Professor in Pharmaceutics and Joy Puzzo Pharmaceutical Technology Stane Srcic Trinity College Dublin, Ireland Professor University of Ljubljana, Slovenia Deirdre Hurley Senior Director, Plant Griet Van Vaerenbergh Helsinn Birex GEA Process Engineering Pharmaceuticals Ltd. Benoît Verjans Editorial: All submissions will be handled with reasonable care, but the publisher assumes no responsibility for safety of artwork, photographs, or manuscripts. Every Makarand Jawadekar CEO precaution is taken to ensure accuracy, but the publisher cannot accept responsibility for the accuracy of information supplied herein or for any opinion expressed. Independent Consultant Arlenda Subscriptions: Tony Wright Pharmaceutical Technology Europe is free to qualified subscribers in Europe. Henrik Johanning To apply for a free subscription, or to change your name or address, go CEO, Senior Consultant, Managing Director to PharmTech.com, click on Subscribe, & follow the prompts. Exelsius To cancel your subscription, please email your request to [email protected], Genau & More A/S putting PTE in the subject line. Marina Levina Please quote your subscription number if you have it. Product Owner-OSD, TTC- For reprints contact Michael Tracey, [email protected]. Tablets Technology Cell, GMS GlaxoSmithKline Copyright 2020 Mulitmedia UK, LLC all rights reserved. No part of the publication may be reproduced in any material form (including photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other use of this publication) without the written Above is a partial list of the Pharmaceutical Technology brand editorial advisory permission of the copyright owner except in accordance with the provisions of the Copyright Designs & Patents Act (UK) 1988 or under the terms of the license issued members. The full board, which includes advisory members of Pharmaceutical by the Copyright License Agency’s 90 Tottenham Court Road, Lindon W1P 0LP, UK. Technology North America, can be found online at www.PharmTech.com/pharmtech- editorial-advisory-board. Pharmaceutical Technology publishes contributed technical Applications for the copyright owner’s permission to reproduce any part of this publication outside of the Copyright Designs & articles that undergo a rigorous, double-blind peer-review process involving members Patents Act (UK) 1988 provisions, should be forwarded in writing to of our distinguished Editorial Advisory Board. Manuscripts for editorial consideration Permission Dept. or email: [email protected]. Warning: should be sent directly to Susan Haigney, managing editor, [email protected]. the doing of an unauthorized act in relation to a copyright work may 10% Post Consumer result in both a civil claim for damages and criminal prosecution. Waste 4 Pharmaceutical Technology Europe APRIL 2020 PharmTech.com EDITOR’S COMMENT Making Every Effort hile the majority Regulatory response that are not yet proven to be effective in W of the world is in The global pandemic of COVID-19 the treatment of COVID-19. As reported isolation to try to slow has been pushing the boundaries of by The Guardian people suffering from the spread of the virus regulatory possibilities
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