Public Opinion

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. 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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. 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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. 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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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