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Public Opinion Vo lume 44 Number 1 JANUARY 2020 Volume 44 Number 1 Advancing Development & Manufacturing PharmTech.com Navigating Rocky PH ARMACEUTICAL TECHNOLOGY Public Opinion Special Coverage Annual Employment Survey Human Element in Pharma Development 2019 Drug Approvals Formulating Biologics Manufacturing Predictive Maintenance Wet Granulation PAT Quality/Regulations Getting to the Root Cause VHP Decontamination Myths JANUARY 2020 JANUARY Operations Sustainable Packaging Peer-Review Research Oral Reconstitutable PharmTech.com Suspension Analysis the next highly potent compound... Let’s develop it together. Specialty expertise in highly potent APIs We also offer particle engineering Visit pharma.lonza.com (particle size reduction and spray drying) Email [email protected] Identifying a collaboration partner that under isolation as well as specialized dosage © 2020 Lonza. All rights reserved. can meet the aggressive timelines often forms designed for highly potent, low dose associated with highly potent drug candidates applications. We have more than 20 years’ is critical. At Lonza Pharma & Biotech, we track record in HPAPI manufacturing and offer the necessary development, upscaling compressed scale-up timelines. and manufacturing capabilities under full containment that support API handling to A partner that you can count on for all exposure levels to 1ng/m3. aspects of your drug program – Lonza. LPB HPAPI 1219 – Pharmaceutical Technology US HPAPI_Ad_PharmTech_US_final.indd 1 12/17/19 11:33 AM BIG Pharma? BIG Mixers. Ross supplies the largest Double Planetary Mixers in the Pharmaceutical Industry. Sanitary design, IQ/OQ documentation, SIP capability. Perfect for mixing and homogenous granulations. Custom PLC recipe controls are available to optimize your batch data and meet CFR-21 requirements. With units sized from 200mL to 4000L, Ross has the Double Planetary Mixer to fit your process. Learn more at mixers.com. Call 1-800-243-ROSS or try ourr free online Knowledge Base & Product Selector web app at mixers.com/web-app. 4000L 200mL Scan to learn more. magentablackcyanyellow 36017110788_6559280.pgs 10.12.2017 00:19 ADVANSTAR_PDF/X-1a EDITORIAL SALES Editorial Director Rita Peters [email protected] Publisher Mike Tracey [email protected] Senior Editor Agnes Shanley [email protected] East Coast Sales Manager Joel Kern [email protected] Managing Editor Susan Haigney [email protected] Mid West, West Coast Sales Manager BJ Ghiglione [email protected] European Editor Felicity Thomas [email protected] European Sales Manager Linda Hewitt [email protected] Manufacturing Editor Jennifer Markarian [email protected] European Senior Sales Executive Stephen Cleland [email protected] Science Editor Feliza Mirasol [email protected] Executive Assistant Barbara Sefchick [email protected] Assistant Editor Lauren Lavelle [email protected] C.A.S.T. Data and List Information Michael Kushner [email protected] Senior Art Director Marie Maresco; Graphic Designer Maria Reyes VP/Managing Director, Pharm/Science Group Dave Esola Contributing Editors Jill Wechsler [email protected]; Hallie Forcinio [email protected]; ADDRESS Susan J. Schniepp [email protected]; Eric Langer [email protected]; 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA and Cynthia A. Challener, PhD [email protected] Tel. 732.596.0276, Fax 732.647.1235 Correspondent Sean Milmo (Europe, [email protected]) PharmTech.com 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA Tel. 732.596.0276, Fax 732.647.1235, PharmTech.com Permissions Alexa Rockenstein, [email protected] EDITORIAL ADVISORY BOARD Audience Development Research Director Pharmaceutical Technology publishes contributed technical articles that undergo a Christine Shappell [email protected] rigorous, double-blind peer-review process involving members of our distinguished Editorial Advisory Board. Manuscripts should be sent directly to the managing editor. Below is a partial list of the TM Pharmaceutical Technology brand editorial advisory members. The full board, which includes advisory members MJH LIFE SCIENCES from Pharmaceutical Technology Europe, can be found online at PharmTech.com. Chairman and Founder Mike Hennessy, Sr Vice Chairman Jack Lepping James P. Agalloco Sanjay Garg, PhD Moheb M. Nasr, PhD President and CEO Mike Hennessy, Jr President Professor and Director, Principal Agalloco & Associates Centre for Pharmaceutical Nasr Pharma Regulatory Consulting Chief Financial Officer Neil Glasser, CPA/CFE Innovation and Development, Larry L. Augsburger, PhD University of South Australia Garnet E. Peck, PhD Executive Vice President, Operations Tom Tolvé Professor Emeritus Professor Emeritus of Industrial University of Maryland R. Gary Hollenbeck, PhD Pharmacy, Purdue University Senior Vice President, Content Silas Inman Research Faculty Senior Vice President, I.T. & Enterprise Systems John Moricone David H. Bergstrom, PhD University of Maryland Wendy Saffell-Clemmer Senior Vice-President, School of Pharmacy Director, Research Senior Vice President, Audience Generation & Product Fulfillment Joy Puzzo Pharmaceutical Development & Baxter Healthcare Corporate Quality Assurance Ruey-ching (Richard) Hwang, PhD Vice President, Human Resources & Administration Shari Lundenberg Antares Pharma, Inc. Senior Director, Gurvinder Singh Rekhi, PhD Pharmaceutical Sciences, Department of Pharmaceutical and Vice President, Business Intelligence Chris Hennessy Phil Borman, DSc Pfizer Global R&D Biomedical Sciences, Director The University of Georgia College Vice President, Corporate Branding & B2B Marketing Amy Erdman Product Development & Supply Maik W. Jornitz of Pharmacy Executive Creative Director, Creative Services Jeff Brown Medicinal Science & Technology President Susan. J. Schniepp Pharma R&D G-CON Manufacturing Inc. GlaxoSmithKline Executive Vice-President of Mansoor A. Khan, PhD Post-approval Pharmaceuticals and Evonne Brennan Professor & Vice Dean Distinguished Fellow International Technical Marketing Irma Lerma Rangel College of Regulatory Compliance Associates Manager, Pharmaceutical Division, Pharmacy, Texas A&M Health David R. Schoneker IMCD Ireland Science Center Director of Global Regulatory Affairs, Rory Budihandojo Russell E. Madsen Colorcon Lachman Consultants President, Aloka Srinivasan The Williamsburg Group, LLC Metin Çelik, PhD VP, Regulatory President, Heidi M. Mansour, PhD Lachman Consultants Pharmaceutical Technologies Assistant Professor Read board members’ International (PTI) College of Pharmacy biographies online at & The BIO5 Research Institute, PharmTech.com/ © 2020 MultiMedia Pharma Sciences LLC All rights reserved. No part of this publication may be reproduced or Zak T. Chowhan, PhD University of Arizona–Tucson transmitted in any form or by any means, electronic or mechanical including by photocopy, recording, or information Consultant, Pharmaceutical pharmtech-editorial- Development Jim Miller advisory-board. storage and retrieval without permission in writing from the publisher. Authorization to photocopy items for internal/ Founder and Former President, educational or personal use, or the internal/educational or personal use of specific clients is granted by MultiMedia Suggy S. Chrai, PhD PharmSource, A Global Data Pharma Sciences LLC for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. President and CEO, Company Chrai Associates, Inc. Danvers, MA 01923, 978-750-8400 fax 978-646-8700 or visit http://www.copyright.com online. For uses beyond those Colin Minchom, PhD listed above, please direct your written request to Permission Dept. or email: [email protected] Roger Dabbah, PhD Senior Director Pharmaceutical Principal Consultant, Sciences, Shire Pharmaceuticals MultiMedia Pharma Sciences LLC provides certain customer contact data (such as customers name, addresses, Tri-Intersect Solutions phone numbers, and e-mail addresses) to third parties who wish to promote relevant products, services, and other R. Christian Moreton, PhD Robert Dream Partner, Finnbrit Consulting opportunities that may be of interest to you. If you do not want MultiMedia Pharma Sciences LLC to make your contact Managing Director information available to third parties for marketing purposes, simply email [email protected] and a customer HDR Company Fernando J. Muzzio, PhD service representative will assist you in removing your name from MultiMedia Pharma Sciences LLC lists. Director, NSF Engineering Tim Freeman Research Center on Structured Managing Director, Pharmaceutical Technology does not verify any claims or other information appearing in any of the advertisements con- Organic Particulate Systems, tained in the publication, and cannot take responsibility for any losses or other damages incurred by readers in reliance FreemanTechnology Dept. of Chemical and Biochemical Engineering, Rutgers University of such content. Pharmaceutical Technology welcomes unsolicited articles, manuscripts, photographs, illustrations, and other materials but cannot be held responsible for their safekeeping or return. Reprints: Contact Mike Tracey, [email protected]. Display, Web, Classified, and Recruitment Advertising: Contact, tel. 732.346.3027. Permissions: Contact Alexa Rockenstein, tel. 732.346.3007, [email protected]. Pharmaceutical Technology’s eNewsletter Team: To subscribe: [email protected] • ePT, Editor Lauren Lavelle, [email protected] • In the Lab,
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