pharmaceutical technology jan 2012

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PLUS:The Authority on Drug Development & ManufacturingPharmTech.comJanuary 2012Volume 36 Number 1FDAs Perspective on Starting MaterialsThe Drug Development and Analytical ToolboxJim Millers Outsourcing Outlook: Contract Services in 2012PEER-REVIEWEDAssessing Tablet-Sticking Propensity AntibodyDrugConjugatesLooking ahead to an emerging classof biotherapeutic Published 9/11 PATH0214R0US HeadquartersPatheon Inc. 4721 Emperor Blvd, Suite 200 Durham, NC 27703-8580 USA P: +1 919 226 3200 F: +1 919 474 2269 www.patheon.comEuropean Headquarters Patheon UK Ltd. Kingfisher Drive Covingham, Swindon Wiltshire SN3 5BZ UK P: +44 1793 524411 F: +44 1793 487053 www.patheon.comCall +1 866-PATHEON (+1 866-728-4366) or email doingbusiness@patheon.comNo other partner gives you more formulation options royalty free.Get access to the industrys widest range of complex formulation technologies for small molecules and biologics, and benefit from expertise forged over thousands of projects.At Patheon, were not tied to any technology. That means science alone drives the development of an optimal formulation, and youll never pay us a royalty. Our commitment is to your success.Choose choice choose Patheon.Sustained-ReleaseImmediate-Release Aseptic FillingMulti-Therapy Solubilization Taste MaskingLyophilizationChoose Choice.4 Pharmaceutical Technology JANUARY 2012 Phar mTech. comGlobePharma, Inc., P.O. Box 7307, North Brunswick, NJ 08902-7307Tol: 732-296-9700 - Fax: 732-296-9898 Bmail: sanniglobopharma.com - wob: www.globopharma.com, FacoBook too! PILOT SCALE BLENDERSMAXIBLEND 5-100PTI0NAI FBAT0RBSVariable speed. Intensier bars for both V-Shells & Bins.Built-in lift system to raise or lower the shell. Stainless steelcart. Portable safety guard. cGMP buttery valve. NIR probes (PAT).STANDARD FBAT0RBS1, 2, 3, 5 and 10 cu. ft. 316L SS, interchangeable V-Shells or Bins. All stainless steel construction. Pharmaceutical nish. On-caster design. PLC controls. Low maintenance. 0.5, 1, 2, 4, 8 and 16 qt. 316L SSinterchangeable V-Shells, Double-Cones & Bins. Large & Small BottleBlending attachments. High speed intonsihor bars. Fixod or variablo speed. PLC controls with timers. Can be supplied with NIR probes {PAT) & tho now SIFT-N-BIBNDattachment for integrated sifting & blending.MAXIBLEND LAB BLENDERALSO AVAILABLE: MINIBLENDALSO AVAILABLE:MAXIBLEND 1-2-3, MAXIBLEND 1-2. LAB BLENDERS NBw SIFT-N-BIBND"(Patent Pending)AVAIIABIB F0R AII BLENDERSSIMPLEBLEND1, 2, 3, 5 & 10 cu. ft. capacityshells. Stand alone, tumble blender with V-Shell, Bin or a Double-Cone Shell. Available with or without intensier bar. Portable.Editorial Director Angie Drakulich adrakulich@advanstar.comExecutive Editor Patricia Van Arnum pvanarnum@advanstar.comManaging Editor Susan Haigney shaigney@advanstar.comEditor (Europe) Rich Whitworth rwhitworth@advanstar.com; Scientific Editor Amy Ritter aritter@advanstar.com; Associate Editors Erik Greb egreb@advanstar.com, Stephanie Sutton ssutton@advanstar.com, and Christopher Allen callen@advanstar.comArt Director Dan Ward Washington Editor Jill Wechsler jwechsler@advanstar.comContributing Editors Jim Miller info@pharmsource.com; Hallie Forcinio editorhal@cs.com; Susan J. Schniepp sue.schniepp@mac.com; Lynn D. Torbeck lynn@torbeck.org; and Eric Langer info@bioplanassociates.com Correspondents Hellen Berger (Latin/South America, hellen.berger@terra.com.br), Sean Milmo (Europe, smilmo@btconnect.com), and Jane Wan (Asia, wanjane@live.com.sg)EDITORIAL OFFICE485 Route One South, Building F, First Floor, Iselin, NJ 08830, USATel. 732.596.0276, Fax 732.647.1235, PharmTech.comEDITORIAL ADVISORY BOARDPharmaceutical Technology publishes contributed technical articles that undergo a rigorous, double-blind peer-review process involving members of our distinguished Editorial Advisory Board. Manuscripts should be sent directly to the managing editor at 485 Route One South, Building F, First Floor, Iselin, NJ 08830, USA.James P. AgallocoPresident, Agalloco & AssociatesLarry L. Augsburger, PhDProfessor, Department of Pharmaceutics, University of MarylandDavid H. Bergstrom, PhDCOO, NovaDel Pharma Inc.Rory BudihandojoDirector, Quality Systems Audit, Boehringer-Ingelheim Shanghai Pharmaceuticals Co. (China)Todd L. CecilVice-PresidentCompendial ScienceUnited States PharmacopeiaMetin elik, PhDPresident, Pharmaceutical Technologies International (PTI)Zak T. Chowhan, PhDConsultant, Pharmaceutical DevelopmentSuggy S. Chrai, PhDPresident and CEO,Chrai Associates, Inc.Roger Dabbah, PhDPrincipal Consultant, Tri-Intersect SolutionsTim FreemanDirector of Operations, FreemanTechnologySanjay Garg, PhDProfessor, Pharmaceutical Sciences, University of South AustraliaR. Gary Hollenbeck, PhDChief Scientific Officer, UPM PharmaceuticalsRuey-ching(Richard) Hwang, PhDSenior Director, Pharmaceutical Sciences,Pfizer Global R&DMansoor A. Khan, PhDDirector, FDA/CDER/DPQRRussell E. MadsenPresident, The Williamsburg Group, LLCHeidi M. Mansour, PhDAssistant Professor,College of Pharmacy, University of KentuckyJim MillerPresident, PharmSource Information Services Bio/Pharmaceutical Outsourcing ReportR. Christian Moreton, PhDVice-President, Pharmaceutical Sciences, Finnbrit ConsultingFernando J. Muzzio, PhDDirector, NSF Engineering Research Center on Structured Organic Particulate Systems, Dept. of Chemical and Biochemical Engineering, Rutgers UniversityMoheb M. Nasr, PhDVice-President, CMC Regulatory Strategy, Global Regulatory Affairs,GlaxoSmithKlineGarnet E. Peck, PhDProfessor Emeritus of Industrial Pharmacy, Purdue UniversityJames Polli, PhDProfessor, School of Pharmacy, University of Maryland Gurvinder Singh Rekhi, PhDDirector,Research and Development, Elan Drug Delivery Inc.Susan J. SchnieppPharmaceutical Consultant, Schniepp & Associates, LLCDavid R. SchonekerDirector of Global Regulatory Affairs, ColorconEric B. Sheinin, PhDPresident, Sheinin and AssociatesCharles A. Signorino, PhDCEO, Emerson Resources, Inc.Heinz Sucker, PhDProfessor Emeritus,Pharmaceutical Institute, University of BernScott Sutton, PhDMicrobiology NetworkLynn D. TorbeckStatistician, PharmStat ConsultingRead board members biographies online at PharmTech.com/eab.Pharmaceutical Technologys eNewsletter Team: ePT, Editor Christopher Allen, ptpress@advanstar.com Sourcing and Management, Editor Patricia Van Arnum, pvanarnum@advanstar.com Equipment & Processing Report, send content and ideas to adrakulich@advanstar.com Send product releases to ptpress@advanstar.comwww.sterile.com 1-888-4-STERILEFor more than 30 years, VAI has pioneered the designand manufacture of hundreds of clean room solutions. Quadruple Bagged using the ABCD Introduction System Cleanest wipein the industry Asepti-Fill closedlling system Laundered in Class 1 Saturated wipesare made with WFI Lot SpecicDocumentionfor all wipers Laser cut sealed edgesNo other company oers this broad a range of wipersDASWipeStainless Steelcleaning andlubricant wipeSTERI-PEROX WIPESaturatedHydrogenPeroxide WipeHYPO-CHLOR WipeSaturated Sodium Hypochlorite WipeDECONClean WipeRemoves residue from disinfecting agentsALCOH-WipeSaturated with DECON-AHOL WFI 70% USP Isopropyl AlcoholSTEELBRIGHT WipeStainless Steel Cleaning wipe70% USP IPAin Water for Injectionsaturated wipeDry cleaning wipe6 Pharmaceutical Technology JANUARY 2012 Phar mTech. comSALES OFFICEPublisher Michael Tracey mtracey@advanstar.comDirector of Sales Paul Milazzo pmilazzo@advanstar.comEastern Sales Manager Suzanne Fillweber sfillweber@advanstar.comMid-West Sales Manager Irene Onesto ionesto@advanstar.comDisplay, Web, Classified, and Recruitment Representative Tod McCloskey tmccloskey@advanstar.com,Executive Assistant Barbara Sefchick bsefchick@advanstar.com485 Route One South, Building F, First Floor, Iselin, NJ 08830, USATel. 732.596.0276, Fax 732.647.1235, PharmTech.comSr. Production Manager Karen Lenzen, International Licensing Maureen Cannon mcannon@advanstar.com, tel. 440.891.2742 or toll-free 800.225.4569 ext 2742, fax. 440-891-2650, Circulation Manager Anne Brugman President, CEO Joseph Loggia, Executive Vice-President, Finance & CFO Ted Alpert, Executive Vice-President of Corporate Development Eric I. Lisman, Chief Administrative Officer Tom Ehardt, Executive Vice-President, Pharma/Science Group Ron Wall, Vice-President/General Manager, Pharma/Science Group David C. Esola, Vice-President, Information Technology J. Vaughn, Vice-President of Media Operations Francis Heid, Vice-President of Human Resources Nancy Nugent, Vice-President, General Counsel Ward D. Hewins, Director of Content Peter Houston 2012 Advanstar Communications Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any formor by any means, electronic or mechanical including by photocopy, recording, or information storage and retrieval without permission in writing fromthe publisher. Authorization to photocopy items for internal/educational or personal use, or the internal/educational or personal use of specific clients is granted by Advanstar Communications Inc. 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 http://www.copyright.comonline. For uses beyond those listed above, please direct your written request to Permission Dept. fax 440.756.5255 or email: mcannon@advanstar.com.Advanstar Communications Inc. provides certain customer contact data (such as customers name, addresses, phone numbers, and e-mail addresses) to third parties who wish to promote relevant products, services, and other opportunities that may be of interest to you. If you do not want Advanstar Communications Inc. 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

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