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/Shutterstock.com; Animated CoverÐDmitry Kalinovsky/Jarun Ontakrai/ leungchopanm/Craftsmanship/PRO Stock Professional/Cergios/macondo/EtiAmmos/Shutterstock.com Biologics and Sterile Drug Manufacturing 2018 EDITORIAL Editorial Director Rita Peters rita.peters@ubm.com Senior Editor Agnes Shanley agnes.m.shanley@ubm.com Managing Editor Susan Haigney susan.haigney@ubm.com Science Editor Adeline Siew, PhD adeline.siew@ubm.com Manufacturing Editor Jennifer Markarian jennifer.markarian@ubm.com Science Editor Feliza Mirasol feliza.mirasol@ubm.com Associate Editor Amber Lowry amber.lowry@ubm.com Art Director Dan Ward Contributing Editors Jill Wechsler jillwechsler7@gmail.com; Jim Miller jim@ludwinmiller.com; Hallie Forcinio editorhal@cs.com; Susan J. Schniepp sue.schniepp@mac.com; Eric Langer info@bioplanassociates.com; and Cynthia A. Challener, PhD challener@vtlink.net Correspondent Sean Milmo (Europe, smilmo@btconnect.com) Address 485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA Tel. 732.596.0276, Fax 732.647.1235 PharmTech.com SALES Publisher Mike Tracey mike.tracey@ubm.com West Coast/Mid-West Sales Manager Irene Onesto irene.onesto@ubm.com East Coast Sales Manager Joel Kern joel.kern@ubm.com European Sales Manager Linda Hewitt linda.hewitt@ubm.com European Senior Sales Executive Stephen Cleland stephen.cleland@ubm.com Executive Assistant Barbara Sefchick barbara.sefchick@ubm.com C.A.S.T. Data and List Information Michael Kushner michael.kushner@ubm.com Sr. Production Manager Karen Lenzen International Licensing Jillyn Frommer Jillyn.Frommer@ubm.com, tel. (732) 346-3007, fax. (732) 647-1104 Audience Development Research Director Christine Shappell Christine.shappel@ubm.com Thomas W. 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