Pharmaceutical Technology - May 2018

Pharmaceutical Technology eBook - Biologics and Sterile Drug Manufacturing

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P h a r mTe c h . c o m ASEPTIC PROCESSING VIEWPOINT 4 Lies That Environmental Monitoring Systems Tell James Agalloco, Russell Madsen, and James Akers DEVELOPING TECHNOLOGIES 8 Albumin Attachment Can Make Better Biobetters Feliza Mirasol PROCESS MODELING 14 Characterizing a Bioprocess with Advanced Data Analytics Lennart Eriksson and Chris McCready BIOREACTOR DESIGN 20 Impact of Agitator Design on Bioreactor Performance Aaron Strand and Nicolle Courtemanche OPTIMIZING LYOPHILIZATION 26 Can Standards Help Pharma Modernize Lyophilization? Agnes Shanley LYOPHILIZATION 30 Residual Moisture Testing Methods for Lyophilized Drug Products Amy M. Bosch and Edward H. Trappler TECH TRANSFER 40 Aseptic Transfer Technology: Weighing Up the Advantages of Varying Approaches for Sterile Drug Manufacturing Christian Dunne FILL/FINISH 44 Ready-to-Use Parenteral Packaging Components Address Evolving Aseptic Fill/Finish Requirements Simon Cote 48 New Technologies Streamline Fill/Finish Manufacturing Amber Lowry QUALITY 50 Understanding Validation and Technical Transfer Russell E. Madsen 62 Ad Index Cover Images: Static CoverÐitsmejust/; Animated CoverÐDmitry Kalinovsky/Jarun Ontakrai/ leungchopanm/Craftsmanship/PRO Stock Professional/Cergios/macondo/EtiAmmos/ Biologics and Sterile Drug Manufacturing 2018 EDITORIAL Editorial Director Rita Peters Senior Editor Agnes Shanley Managing Editor Susan Haigney Science Editor Adeline Siew, PhD Manufacturing Editor Jennifer Markarian Science Editor Feliza Mirasol Associate Editor Amber Lowry Art Director Dan Ward Contributing Editors Jill Wechsler; Jim Miller; Hallie Forcinio; Susan J. Schniepp; Eric Langer; and Cynthia A. Challener, PhD Correspondent Sean Milmo (Europe, Address 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA Tel. 732.596.0276, Fax 732.647.1235 SALES Publisher Mike Tracey West Coast/Mid-West Sales Manager Irene Onesto East Coast Sales Manager Joel Kern European Sales Manager Linda Hewitt European Senior Sales Executive Stephen Cleland Executive Assistant Barbara Sefchick C.A.S.T. Data and List Information Michael Kushner Sr. Production Manager Karen Lenzen International Licensing Jillyn Frommer, tel. (732) 346-3007, fax. (732) 647-1104 Audience Development Research Director Christine Shappell Thomas W. Ehardt Executive Vice-President, Senior Managing Director, UBM Life Sciences Group Dave Esola VP/Managing Director, Pharm/Science Group, UBM Life Sciences UBM Americas provides certain customer contact data (such as customers name, addresses, phone numbers, and e-mail addresses) to third parties who wish to promote relevant prod- ucts, services, and other opportunities that may be of interest to you. If you do not want UBM AmericaÕs to make your contact information available to third parties for marketing purposes, simply call toll-free 866.529.2922 between the hours of 7:30 a.m. and 5 p.m. CST and a customer service representative will assist you in removing your name from UBM AmericaÕ lists. Outside the US, please phone 218.740.6477. Pharmaceutical Technology does not verify any claims or other information appearing in any of the advertisements contained in the publication, and cannot take responsibility for any losses or other damages incurred by readers in reliance of such content. Pharmaceutical Technology welcomes unsolicited articles, manuscripts, photographs, illustra- tions, and other materials but cannot be held responsible for their safekeeping or return. Single issues, back issues: Call toll-free 800.598.6008. Outside the US call 218.740.6480. Licensing and Reuse of Content: Contact our official partner, WrightÕs Media, about available usages, license fees, and award seal artwork at for more information. Please note that WrightÕs Media is the only authorized company that weÕve partnered with for Advanstar UBM materials. Direct mail lists: Contact Tamara Phillips, Marketing Services, tel. 440.891.2773, Display, Web, Classified, and Recruitment Advertising: Contact, tel. 732.346.3027. Permissions: Contact Jillyn Frommer, tel. 732.346.3007, fax. 732.647.1104, To subscribe: Call toll-free 888.527.7008. Outside the U.S. call 218.740.6477. © 2018 UBM All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, elec- tronic or mechanical including by photocopy, recording, or information storage and retrieval without permission in writing from the publisher. Authorization to photocopy items for internal/educational or personal use, or the internal/educational or personal use of specific clients is granted by UBM for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 fax 978-646-8700 or visit online. For uses beyond those listed above, please direct your written request to Permission Dept. fax 732-647-1104 or email:

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