Biopharmaceutical Manufacturing, Capacity, and … Geoff Hodge, Vice President, Process Development and Technology, Xcellerex Geoffrey Hodge is Vice President, Process Development

4th Annual Report and Survey of Biopharmaceutical Manufacturing, Capacity, and Production

A Study of Biotherapeutic Developers and

Contract Manufacturing Organizations

2006

BioPlan Associates, Inc.15200 Shady Grove Road, Suite 202Rockville, MD 20850 USA301-921-9074

Copyright ©2006 by BioPlan Associates, Inc. All rights reserved. Unauthorized reproduction prohibited.

4th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and ProductionA Study of Biotherapeutic Developers and Contract Manufacturing Organizations, 2006

BioPlan Associates, Inc. 15200 Shady Grove Road, Suite 202Rockville MD 20850301-921-9074www.bioplanassociates.com

Copyright © 2006 by BioPlan Associates, Inc.

All rights reserved, including the right of reproduction in whole or in part in any form. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopy-ing, recording or otherwise, without the written permission of the publisher.

For information on special discounts or permissions contact BioPlan Associates, Inc. at 301-921-9074, or [email protected]

Managing Editor: Eric S. LangerText and Cover Design: ES Design, Alexandria, VALayout: Emerald Ong, Washington, DC

ISBN 0-9760605-8-2

iii

A C k n O w l e D g e M e n tWe wish to acknowledge the contributions of our authors, without whom the thorough analysis of the data in this project would not have been possible.

• Geoff Hodge, Vice President, Technology, Xcellerex

• Barbara Immel, President, Immel Resources

• Howard L. Levine, President and Founder, BioProcess Technology Consultants

• Deborah Moon, President, Technical Sales Association

• LeighPierce,President,PacificGMP

• Thomas C. Ransohoff, Sr. Consultant, BioProcess Technology Consultants

• Scott Wheelwright, President, Strategic Manufacturing Worldwide

We would also like to recognize our sponsoring organizations, and our media sponsor. Their efforts in assuring the cooperation and participation in the survey of their respective mem-berships helped guarantee the largest group of survey participants thus far.

Our Sponsoring organizations include:

• BayBio (South San Francisco CA),

• BioProcessUK (London, United Kingdom)

• EuropaBIO (Brussels, Belgium), and

• Massachusetts Biotechnology Council (Cambridge, MA)

All contributed their time and effort to ensure the broad, international coverage of this project.

We also wish to thank our media sponsor for helping ensure broad, and representative coverage of industry participation:

• BioProcess International, (Westborough, MA)

The early participation of our authors and sponsors in evaluating the areas and trends to survey this year ensured the project covered the most relevant issues in biopharmaceutical manufactur-ing today. Their support was, again this year, critical to the success of the project.

Eric S. LangerEditor

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e D i t O R

Eric S. Langer, MS, President, BioPlan Associates, Inc. Mr. Langer is President and Managing Partner of BioPlan Associates, Inc. a biotechnology and life sciences consulting company that has been providing management and market strategy services, and technology analysis to biopharmaceutical and healthcare organizations since 1989. He has over 19 years experience in biotechnology and life sciences management and market assessment. He is an experienced medical and biotechnology industry practitioner, strategist, researcher, and science writer. He has held senior management and marketing posi-tions at biopharmaceutical supply companies. He teaches Biotechnology Marketing, Market-ing Management, Services Marketing, Advertising Strategy, and Bioscience Communication at Johns Hopkins University, American University, and lectures extensively on pricing and channel management topics. Mr. Langer has a degree in Chemistry and Masters in International Busi-ness. He has written and consulted extensively for companies involved in: large scale biophar-maceutical manufacturing, cell culture, media, sera, tissue engineering, stem cells, diagnostic products,bloodproducts,genetics,DNA/PCRpurification,bloodcomponents,andmanyotherareas.

A B O u t t h e A u t h O R S

James V. Blackwell, Senior Consultant, BioProcess Technology ConsultantsJames V. Blackwell, PhD, has over 13 years experience in manufacturing, cell culture and fer-mentation technologies, biopharmaceutical development, and technical operations. He has held senior management and technical positions with Abbott Bioresearch Center, Genzyme and Rep-ligen Corporations. While at the Abbott Bioresearch Center, Dr. Blackwell oversaw site technical support for HUMIRA® arthritis drug production and served on the site validation review board and quality management teams. He also served on the project team for Abbott’s re-organization of its global pharmaceutical operations. At Genzyme, Dr. Blackwell provided technical support for several prominent commercial and clinical projects. He has also been a research scientist in cell culture and fermentation process development at Genzyme and Repligen. He is Past President of the Greater Boston Chapter of ISPE, a society for pharmaceutical manufacturing professionals, and serves on its Process and Product Development Committee at the society’s international level. Dr. Blackwell has Bachelor’s and Master’s degrees in Chemical Engineering and Microbiology, respectively, from The Ohio State University. He has a Doctorate degree in Chemical Engineering from Northeastern University and received dual Master’s degrees in Busi-ness Administration and Technology Management from the University of Maryland.

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Geoff Hodge, Vice President, Process Development and Technology, XcellerexGeoffrey Hodge is Vice President, Process Development and Technology at Xcellerex, a con-tract manufacturing and development company based in Marlborough, Massachusetts. He is responsibleforprocessdevelopmentandtheidentification,developmentandintegrationofnew technologies into the Xcellerex technology platform. Prior to joining Xcellerex, Mr. Hodge was Associate Director of Process Development at Millennium Pharmaceuticals, Cambridge, MA, with responsibility for the process development and clinical manufacturing of Millennium’s biologics pipeline. In this role he pioneered the use of disposable manufacturing systems for the production of monoclonal antibodies and helped to develop a novel manufacturing platform and many of the high-throughput process development technologies subsequently licensed to Xcellerex. Mr. Hodge has also held positions in commercial manufacturing as Manufacturing Section Head at Genetics Institute (now Wyeth BioPharma), Andover, Massachusetts, and vari-ous management positions in process development, clinical manufacturing, manufacturing and validation at Alpha-Beta Technology, Worcester, Massachusetts. Mr. Hodge received his B.A. in Biology from Colgate University, and his M.S. in Biotechnology from Worcester Polytechnic Institute.

Barbara K. Immel, President, Immel Resources LLCMs. Immel is president of Immel Resources LLC, and editor of the Immel ReportTM. She has 24 years of industry experience, working in compliance and training, documentation and label-ing, corporate quality assurance and marketing for Syva Company, Chiron Corporation, and Syntex Corporation for more than 12 years before starting the company. Barbara has served as a GMP and regulatory compliance columnist with BioPharm Magazine since 1996. She has published more than 50 articles. She wrote the Quality Assurance of Pharmaceuticals chapter for the Dekker Encyclopedia of Pharmaceutical Technology. Barbara has presented at hundreds of national and international industry meetings, and has taught GMP classes for 20 years. She has taught biotechnology and drug development courses for UC Berkeley Extension, served as an instructor for the Pharmaceutical and Biotechnology Quality Assurance Course for the University of Wisconsin at Madison, served as a panelist at the Stanford Professional Publish-ing Course, and recently taught a tutorial on FDA’s phase 1 proposals at the 30th Annual GMP Conference, University of Georgia. She was elected to serve on the national training committees for trade associations, PhRMA and PDA, for eight years, where she helped plan and organize educational conferences for training professionals. She is a graduate of the Buckley School of Public Speaking, the Stanford Professional Publishing Course, and the University of California, Santa Barbara. Honors and awards.

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Howard L. Levine, PhD, President and Founder, BioProcess Technology Consultants Dr. Levine has over 20 years of experience in the biopharmaceutical industry. Prior to founding BioProcess Technology Consultants to provide process development, manufacturing, qual-ity control and quality assurance assistance to biopharmaceutical clients, Dr. Levine was Vice President of Manufacturing Operations at Repligen Corporation. There, he was responsible for all process development and manufacturing activities, including production of therapeutic proteins and monoclonal antibodies and recombinant Protein A. Dr. Levine previously held posi-tions of increasing responsibility in process development and manufacturing at Genentech, Am-gen, and Xoma. Dr. Levine is currently a member of the Editorial Advisory Boards of BioPharm Magazine, BioProcess International, and Bio/Pharmaceutical Outsourcing Report. He is also a memberoftheNeoseTechnologies,Inc.GlycoAdvanceAdvisoryBoard,andisontheScientificAdvisory Boards of AsepCo and the Boston Area Chapter of the International Society of Phar-maceutical Engineering (ISPE). He was chairman of the Parenteral Drug Association’s (PDA) Task Force on Chromatography Validation; has lectured extensively on manufacturing strategy, downstream processing, and manufacturing in biotechnology; and is co-editor of a directory of biologics contract manufacturers. Dr. Levine holds a PhD in chemistry from the University of Chicago and completed a postdoctoral fellowship at Harvard University.

Thomas C. Ransohoff, Senior Consultant, BioProcess Technology ConsultantsMr. Ransohoff is a Senior Consultant with over 15 years of experience in the biopharmaceuti-cal industry. Mr. Ransohoff’s areas of expertise include development and scale-up of biophar-maceuticalprocesses;separationsandpurificationtechnologies;cGMPmanufacturing;andprocess economics. Before joining BioProcess Technology Consultants, Mr. Ransohoff was VicePresident,OperationsatTranXenoGen,Inc.,responsibleforpurificationprocessdevelop-ment and facilities. Prior to that he was Vice President, Bioseparations at Dyax Corp, where he wasinstrumentalinestablishingabusinessunittodevelopnovelaffinityseparationsproductsusing phage display technology. At Repligen, Mr. Ransohoff was Senior Director, Manufactur-ing, responsible for cGMP pilot plant operations producing material for clinical trials and reagent products such as Protein A for commercial sale. He is a member of the Editorial Advisory Board ofBioPharmMagazineandhasservedonanumberofscientificadvisoryboards,includingtheNational Research Council Committee on Opportunities in Biotechnology for Future Army Appli-cations and the Boston Area Chapter of ISPE. Mr. Ransohoff has a Bachelor’s degree from MIT and a Master’s degree from UC-Berkeley, both in Chemical Engineering.

Deborah Moon, President, Technical Sales AssociationDeborah Moon is President of the Technical Sales Association (TSA). As a national organization, TSA is dedicated to the advancement and recognition of the technical selling profession and its benefitstomembers.Throughanetworkofmorethan500individuals,TSAiscommittedtoful-fillingitsmission.ThroughTSA,membersmeetcolleaguesfromthetechnicalsellingprofessionas well as researchers, scientists and technicians, and establish a network/information base that is vital to continued professional advancement. Debbie Moon has worked as a technical sales representative for more than 15 years.

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Leigh N. Pierce. President, PacificGMPLeigh Pierce has over 15 years experience in the biotechnology industry and is currently the PresidentofPacificGMP,acontractmanufacturingorganizationthatspecializesinthedevelop-ment and manufacturing of biologics utilizing disposable technology. Formerly, she was Presi-dentofPierceBioDevelopment,aconsultingfirmthatassistspharmaceuticalcompanieswithdevelopment and manufacturing of biologics. Prior to consulting, she was Manager of Process Development and Manufacturing of mammalian cell culture products at Arizeke Pharmaceuti-cals, Inc. In less than a year, Ms. Pierce was able to take Arizeke’s lead compound from a DNA construct to a 500L scale production utilizing disposable technology. At Immusol, Inc. she iden-tifiedgenesinvolvedwithregulatingbreastcancergenesandassistedwiththedevelopmentof Immusol’s patented Inverse Genomics™ platform. At Chiron Center for Gene Therapy, she developed, optimized and scaled-up new methods of recombinant retrovirus production.

Scott M. Wheelwright, PhD, Founder and Principal, Strategic Manufacturing Worldwide, Inc. Dr. Wheelwright has over twenty years experience in bringing novel products to market, includ-ing new drug applications (BLAs and NDAs) in the US and Japan, numerous investigational ap-plications (INDs) and commercial product launches. Dr. Wheelwright’s work experience encom-passespharmaceuticalfirmsandbothlargeandsmallbiotechcompanies,includingAbbott,Chiron, Scios, Calydon, DURECT and Genitope. Dr. Wheelwright received his PhD in chemical engineering from the University of California at Berkeley and continued post-doctoral studies at the Max Planck Institute for Biophysics in Frankfurt, Germany. He is the author of a book on proteinpurificationandhaspublishednumerousarticlesonmanufacturingandprocessdevel-opment. Dr. Wheelwright’s focus is on long-term strategic and near-term planning for develop-ment (CMC issues including process development, analytical testing and characterization), manufacturing and facilities. He has lead project teams that have conducted technology trans-fer within the US and overseas, supervised scaleup at CMOs and managed complex projects involving multiple outsource vendors.

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4th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

C O n t e n t S

About the Authors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv

Overview and Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .xiii

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .xiii

MethOdOlOgy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .xiv

Chapter 1: Introduction and Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 .1

1.1 intrOductiOn . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.1

1.2 State Of the BiOpharMaceutical induStry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.3

1.3 need fOr iMprOveMentS in prOductiOn . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.4Biotherapeutic Developers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.4CMOs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.5Industry Suppliers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.5Government . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.5

Chapter 2: Demographics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 .1Area of Involvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.2Respondents’ Titles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.3Facility Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.4Respondents’ Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.5Respondents’ Areas of Biopharmaceutical Manufacturing Operations . . . . . . . . . . . .2.6Respondents’ Production Operations, Phase of Development . . . . . . . . . . . . . . . . . .2.7

Chapter 3: Capacity Constraints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 .1

3.1 current prOductiOn . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1Current Production as Percent of Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.1Changes in Capacity Utilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.2


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3.2 diScuSSiOn . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2

3.3 current tOtal prOductiOn capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.5Mammalian Cell Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.5Microbial Fermentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.9Yeast Production . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.10Insect Cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.11

3.4 Overall induStry capacity utilizatiOn . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.12Overall Industry Capacity, Average, All Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.12CMOs vs Biotherapeutic Developers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.13

3.5 diScuSSiOn . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.15

Chapter 4: Current Capacity Constraints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 .1

4.1 current capacity cOnStraintS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1Perception of Capacity Constraints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.12006 vs 2005 and 2003 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.2CMOs vs Biotherapeutic Developers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.4

4.2 future capacity cOnStraintS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.5Expectations of Capacity Constraints by 2011 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.52003 to 2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.6CMO / Biotherapeutic Developer Capacity Constraints by 2011 . . . . . . . . . . . . . . . . .4.7

4.3 factOrS iMpacting future prOductiOn capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.8Factors Creating Capacity Constraints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.8CMO vs Biotherapeutic Developers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.10US vs European Respondents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.12

4.4 Key areaS tO addreSS tO avOid capacity cOnStraintS . . . . . . . . . . . . . . . . . . . . . . . . .4.14CMOs vs Biotherapeutic Developers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.17US vs European Respondents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.19

Chapter 5: Future Capacity Expansions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 .1

5.1 planned future capacity expanSiOnS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.12008 vs 2011 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.3CMOs vs Biotherapeutic Developers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.4Planned Future Capacity Expansions of >100% . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.5

5.2 current OutSOurcing, By prOductiOn SySteM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6Facilities Currently Outsourcing No Production in 2006, vs 2005 . . . . . . . . . . . . . . . .5.7

5.3 future OutSOurcing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.8Biotherapeutic Developers’ Outsourcing, 2011 Projections, by System . . . . . . . . . . .5.8Biotherapeutic Developers Outsourcing Some Production in 2011 . . . . . . . . . . . . . . .5.9

5.4 critical OutSOurcing iSSueS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.10Selecting a CMO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.102006 vs 2005 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.12Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.14

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Chapter 6: Disposables and Single-Use Systems in Biopharmaceutical Manufacturing . . . . .6 .1

6.1 uSe Of diSpOSaBleS and Single-uSe SySteMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.1Use of Disposables, 2006 vs 2005 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.2CMOs vs Biotherapeutic Developers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.4

6.2 increaSing uSe Of diSpOSaBleS & Single-uSe SySteMS . . . . . . . . . . . . . . . . . . . . . . . 6.6Reasons for Increased Use of Disposables, 2006 vs 2005 . . . . . . . . . . . . . . . . . . . . .6.8CMOs vs Biotherapeutic Developers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.8Reasons for Increased Use of Disposables, 2006 vs 2005 . . . . . . . . . . . . . . . . . . . .6.10

6.3 factOrS reStricting uSe Of diSpOSaBleS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.12Reasons for Restricting Usage of Disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.122006 vs 2005 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.14CMOs vs Biotherapeutic Developers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.16

6.4 current Spending On diSpOSaBle SySteMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.18CMOs vs Biotherapeutic Developers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.20Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.22

Chapter 7: Downstream Purification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 .1

7.1 dOwnStreaM purificatiOn SySteMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.1

7.2 iMpact Of dOwnStreaM prOceSSing On capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.2Biopharmaceutical Developers vs CMOs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.3

7.3 areaS where MajOr iMprOveMentS will Occur in dOwnStreaM prOceSSing . . . . . . . 7.4Membrane Technology: Opinions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.6Moving Bed Technology: Opinions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.7

7.4 MicrOfiltratiOn prOBleMS in BiOpharMaceutical dOwnStreaM prOceSSing . . . . . . . . 7.8Filtration Factors in 2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.8Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.10

Chapter 8: Hiring, Employment Growth, and Training in Biopharmaceutical Manufacturing . .8 .1Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8.1 Hiring in 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8.1

8.2 hiring in 2011 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.2

8.3 prOjected eMplOyMent grOwth in BiOpharMaceutical Manufacturing . . . . . . . . . . . . .8.3Growth in Hiring, 2006 to 2007; and 2006 to 2011 . . . . . . . . . . . . . . . . . . . . . . . . . . . .8.3Growth in Hiring, 2006 to 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8.4Growth in Hiring, 2006 to 2011 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8.5Compound Annual Growth Rate, 2006-2011, by Job Function . . . . . . . . . . . . . . . . . .8.6

8.4 fOrMal educatiOn requireMentS in BiOpharMaceutical wOrKfOrce . . . . . . . . . . . . . 8.7Level of Biopharmaceutical Workforce Education . . . . . . . . . . . . . . . . . . . . . . . . . . . .8.72006 vs 2011 Estimate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8.8Distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8.9

8.5 training in BiOpharMaceutical Manufacturing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.10In-House Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8.10External Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8.12


xii

8.7 external training in BiOpharMaceutical Manufacturing . . . . . . . . . . . . . . . . . . . . . 8.14Discussion of Hiring, Growth, Education and Training . . . . . . . . . . . . . . . . . . . . . . . .8.16

Chapter 9: Suppliers to Biopharmaceutical Manufacturing and Life Sciences . . . . . . . . . . . . .9 .1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.1

9.1 deMOgraphicS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9.2Areas of Involvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.2Vendor Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.3Respondents’ Primary Job . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.4

9.2 grOwth rate Of SaleS By SupplierS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9.5Average Industry Growth Rate, Distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.5Average Industry Growth Rate, By Segment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.6

9.3 Supplier iSSueS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9.7Problems Faced by Suppliers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.7Establishing Effective Partnerships with Clients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.8

9.4 SaleS Staff training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9.9Days of Training Provided . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.9Areas Where More Training Needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.10Areas Where More Training Needed, Sales Staff vs All Staff . . . . . . . . . . . . . . . . . . .9.11Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.13About BioPlan Associates, Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.15

O v e R v i e w A n D M e t h O D O l O g y

O v e r v i e wThere are currently over 2,100 large molecule biotechnology medicines in clinical trials around the world, and nearly 3,600 in preclinical development.1 These biotherapeutics target nearly 150 disease states and promise to bring better treatments to patients. However, if new biothera-peutics are to be made more affordable, most industry participants agree that improvements in performance and optimization of processes will be necessary. As the demand for production of biotherapeutics continues to grow, the question of whether current manufacturing capacity and productionperformancearesufficienttodealwiththechallengebecomesanimportantstrate-gic issue.

The ability to meet demand, whether through in-house manufacturing or out-sourced contract manufacturing, carries long-term cost implications. Building production facilities, bringing new capacity on line, and establishing support services in these areas requires accurate market knowledge, lead-time, large capital expenditures, and careful planning.

Both biopharmaceutical producers and contract manufacturers maintain a keen interest in the current and future status of industry capacity and trends. This report summarizes information obtained from worldwide biopharmaceutical manufacturers in March 2006. Its intent is to pro-vide a quantitative assessment of industry capacity, production trends, and benchmarks. As an on-going benchmarking effort, it offers a view into current and future potential industry bottle-necks.

Overview and Methodology

xiii

1 Source: Biopharm Insights 2006 Data (www.biopharminsights.com)

©2006 BioPlan Associates, Inc . All rights reserved . www .bioplanassociates .com


M e t h o d o l o g yThis report is the fourth in a series of annual evaluations by BioPlan Associates, Inc, of the state of the biopharmaceutical manufacturing industry. The strength of the methodology lies in its breadth, which yields a composite view from respondents closest to the industry. BioPlan As-sociates surveyed 377 responsible individuals at biopharmaceutical manufacturers and con-tract manufacturing organizations in 29 countries around the world. The survey methodology also encompassed an additional 157 direct suppliers of materials, services and equipment to this industry. Using a web-based survey tool, we obtained and evaluated information regard-ing respondents’ current capacity, production, human resources, and outsourcing issues. We assessed respondents’ projected reasons for bottlenecks, and their perception of how these bottlenecks might be resolved.

This year, we brought in experts from the industry to provide in-depth analysis of the events shaping the past year, and the trends that will shape 2007:

• James V. Blackwell, Sr. Consultant, BioProcess Technology Consultants

• Geoff Hodge, Vice President, Technology, Xcellerex

• Barbara Immel, President, Immel Resources

• Howard L. Levine, President and Founder, BioProcess Technology Consultants

• Deborah Moon, President, Technical Sales Association

• LeighPierce,President,PacificGMP

• Thomas C. Ransohoff, Sr. Consultant, BioProcess Technology Consultants

• Scott Wheelwright, President and Founder, Strategic Manufacturing Worldwide

The detailed benchmarking information and industry analysis contained here was prepared based on these data, and information from earlier studies. Additional information on methodol-ogy,breakoutsonspecificsegments,anddatafromearliersurveysmaybeobtainedbycon-tacting us at the address below.

Eric S. LangerPresident

BioPlan Associates, Inc.15200 Shady Grove Road, Suite 202Rockville, MD 20850 301-921-9074 [email protected] www.bioplanassociates.com

xiv ©2006 BioPlan Associates, Inc . All rights reserved . www .bioplanassociates .com

C h A P t e R 1 : i n t R O D u C t i O n A n D D i S C u S S i O n

1 .1 I n t r o d u c t i o nWith 284 biopharmaceutical products approved for marketing in the US, and 276 products approved in the EU,1 and 6,083 products in the biopharmaceutical pipeline,2 there is ample evidence of continued growth. Effective planning for biotherapeutic production is strategically important to every biotherapeutic developer, Contract Manufacturing Organization (CMO), and supplier to this industry. The long lead-time required to successfully launch a biotherapeutic requires pre-planning for capacity. This requires a unique level of partnership between manu-facturers and suppliers who are capable of developing new technologies. If production is to continue to keep pace with industry’s need for capacity, these strategic production decisions will need to be based on solid data, trend tracking, and effective benchmarking of capacity and production issues.

Fig. 1-1: Pipeline of Large Molecule (Protein Therapeutics), Worldwide, 2006

Chapter 1: Introduction and Discussion

1.1

Source: 2006 Biopharm Insights Data (www.biopharminsight.com)

1 Biopharmaceutical Products in the US and European Markets, 5th Edition (Aug 2006), BioPlan Associates, Inc. Includes recombinant products, vaccines, and blood derivative products.

2 Source: Biopharm Insights 2006 Data (www.biopharminsights.com)

OthersRecent Product Launches

Pre-Clinical/Discovery

Phase I/IND Filed

Phase II

Phase III

Recent ProductLaunches

5.0%

Pre-Clinical/Discovery

59%

Phase I/IND Filed

15.6%

Phase II14.0%

Phase III5.1%

Others1.3%

# Investigational Drugs NDA/BLA Filed 78Phase III 312Phase II 850Phase I/IND Filed 949Pre-Clinical/Discovery 3,588Recent Product Launches 306

Total 6,083



1.2

Cancer 1,883 28 118 395 365 924 52

Infectious Diseases 1,107 11 71 132 173 613 106

Miscellaneous 542 na 3 3 27 507 2

Central Nervous System 384 4 10 49 44 268 9

Immune System 368 3 19 32 63 244 7

HIV Infections 323 na 4 33 67 217 2

Diagnostic /

Imaging Agents/ Delivery 277 3 na 6 29 227 12

Cardiovascular 213 3 23 36 19 119 13

Musculoskeletal 203 4 16 37 24 82 40

Hematological 162 7 8 21 34 75 17

Hormonal Systems 156 4 13 25 25 76 13

Respiratory 134 na 10 17 32 71 4

Gastrointestinal 129 7 10 30 14 59 9

Dermatology 84 2 1 26 17 29 9

Pain 51 1 2 2 3 39 4

Genitourinary 37 na 3 2 10 17 5

Eye and Ear 32 1 1 4 3 21 2

Total 6,085 78 312 850 949 3,588 306

Source: Biopharm Insight (www.biopharminsight.com)

Total # of Investigational Drugs NDA BLA Filed

Phase III Phase II Phase I IND Filed

Pre-Clinical Discovery

Recent Product

Launches


Table 1-1: Investigational Drugs: Large Molecule (Protein Therapeutics), Worldwide

1.3


1 . 2 S t a t e o f t h e B i o p h a r m a c e u t i c a l I n d u s t r y 3 The biotech industry is celebrating its 30th birthday in 2006 (Genentech was founded on April 7, 1976).4 Since then, the industry has grown from a lone startup to one that generates more than $63 billion worldwide. In 2005, revenues for the world’s publicly traded biotech companies grew by 18 percent, reaching an all-time high of $63.1 billion.5 This increase is similar to previous years’ performance—revenues increased by 17 percent in 2004.

In 2005, the total number of public and private biopharmaceutical companies worldwide was estimated by Ernst & Young in their Beyond Borders, Global Biotechnology Report 2006, as 4,203 companies, with 671 of them being public companies. Worldwide public company R&D expense in 2005 was $20.4 billion, and net loss for the industry was $4.4 billion. Industry em-ployment at public companies in 2004 was estimated at 183,820 employees worldwide, includ-ing137,400(U.S.),25,640(Europe),13,410(Asia-Pacific),and7,370(Canada).6 In their BIO 2005-2006 Guide to Biotechnology, the Biotechnology Industry Organization estimates U.S. biotechnology employment slightly higher, possibly including employment at private companies as well—at 198,300 employees at the end of December 31, 2003.7 In the United States alone, theindustrygained32newproductapprovalsin2005,including17first-timeapprovals.Aver-ageannualwagesin2004foremployeesintheU.S.workingindrugandpharmaceuticalfirmswas $79,303 U.S.—or $40,000 U.S. above the average, private sector annual wage of $39,003.8 Between 2001 and 2004, drugs and pharmaceutical employment in the U.S. grew by 3 percent to 313,000 employees, even in a recessionary period and an era of mergers and acquisitions.

3 We thank Barbara Immel, President of Immel Resources for the industry research in this section, www.immel.com

4 Coming of Age, Beyond Borders: The Global Biotechnology Report 2005, Ernst & Young, www.ey.com/global/download.nsf/International/Beyond_Borders_2005_-_Coming_Age/$file/BeyondBorders2005ComingAge.pdf.

5 Global Introduction and Global Year in Review, Beyond Borders, The Global Biotechnology Report 2006, Ernst & Young, www.ey.com/global/content.nsf/International/Biotechnology_Report_2006_Beyond_Borders.

6 Competitive Growth, Growing Competition, Beyond Borders: The Global Biotechnology Report 2005, Ernst & Young, www.ey.com/global/download.nsf/International/Beyond_Borders_2005_-_Competitive_Growth/$file/BeyondBorders2005Com-petitveGrowthGrowing.pdf

7 Biotechnology Industry Facts, BIO 2005-2006 Guide to Biotechnology, Biotechnology Industry Organization, Washington, D.C., www.bio.org/speeches/pubs/er/.

8 Growing the Nation’s Bioscience Sector: State Bioscience Initiatives 2006, BIO, Biotechnology Industry Organization and Battelle Technology Partnership Practice and SSTI, April 2006, www.bio.org/local/battelle2006/.



1 . 3 N e e d f o r I m p r o v e m e n t s i n P r o d u c t i o nThe need for improvements in production, and its impact on overall capacity requirements, will be a constantly moving target. Given the pipeline of new products being developed, there will be no shortage of need for production improvement. The biopharmaceutical industry contin-uestogrowbothitspipelineanditssupportingtechnology.Asupstreamyieldandefficienciesimprove,bottlenecksformdownstreamatthepurificationend.Suppliersandmanufacturersarebeginning to shift their focus from improving yield to reducing costs, and to addressing process complexities such as downstream processing.

While production capacity constraints in recent years have decreased, the dynamic nature of this business means that trends shift rapidly, and must be watched and benchmarked. As a case in point, organizations once again this year fear near-term capacity constraints. The 5-year projection for capacity problems this year was up 8 percentage points over 2005.

Concurrently, the reliance on CMOs is expected to continue to grow as CMO capacity provides support for biotherapeutic developers and reduce the total risks associated with building addi-tional capacity for regulated products that may not reach the market. The expense of capital will drivecontinuedproductandprocessinnovationsinanefforttodecreasethetotalfixedcapacityrequired for biotherapeutics. Disposable technologies are expanding as manufacturers recog-nize the potential for reducing capital expenses.

Suppliers are being expected to expand their role as participants in the industry’s technology growth. There are opportunities for suppliers to better meet their customer’s needs in areas suchasdownstreampurification,cost-efficientdisposables,regulatorycompliance,andoverallcost reduction.

Tomaximizeefficienciesastheindustryexpands,suppliers,productdevelopers,CMOs,andgovernments should continually question how they are supporting this industry, and whether the available technologies are meeting market needs. Each industry participant should ask questions such as:

Biotherapeutic Developers• Shouldwefocusonincreasingtotalcapacity,orimprovingouroverallefficiency?

• How can we plan more effectively to predict changes in industry forces so that supply anddemandimbalancesarereduced?

• Whichproductiontechnologiesaregoingtobeneededin2-5years?Thislead-timeisneeded for suppliers to develop new technologies that decrease our need for capacity.

• Will outsourcing to lower-cost areas reduce overall costs associated with manufactur-ing?Howwillregulatoryissueschangetohandlesuchshifts?

• How should suppliers and CMOs create agreements, such as licensing, or royalty ar-rangements,thatreduceriskandfinancialexposuretoallparties?

• Can CMOs today meet the expected capacity demands, given the lead time for new pipelineproducts?

• Since availability of a trained workforce is a primary bottleneck to production, what must wedotoretaincurrentbiopharmaceuticalemployees,andattractnewones?

• Howwillwetrainemployeesinthefuture,sothatoverallproductivityincreases?

1.4 ©2006 BioPlan Associates, Inc . All rights reserved . www .bioplanassociates .com


1.3

CMOs• What technologies should we be working on today that can reduce overall costs to our-

selvesandtoourcustomers?

• Whattechnologyplatformsmightbeusedtoreducecostsofscale-up?

• Dowehavereasonablelevelsofavailablecapacityforcustomers’futureneeds?

• Are we actively tracking technology and industry developments so we can support this industryandgrabopportunities?

• Are we providing our customers the level of customer service they need, such as throughbettertechtransfer,andprojectmanagement?Howwillthisimproveoureffi-ciency?

• How can we better support biotherapeutic developers with installed capacity by meet-ingsurgecapacityrequirements?

Industry Suppliers• Are we actively tracking which novel products, services, and technologies the industry

needstoday,andin5years?Thoseneedsmayrequireyearsofnewproductdevelop-ment to provide effective solutions.

• Can we be providing better regulatory support as part of our product or service offer-ing?

• Can we reduce costs for products or services that customers have indicated are too expensiveforthemtobeabletoadopt?

• Do we consider how our products provide a competitive economic advantage to our customers?

Government• In what ways can we attract industry to our region beyond tax breaks or reduction in

red-tape?Doweunderstandwhattheindustryreallyneeds?

• Are we actively working on providing a regional work force ready, willing, and able to meettheneedsoftheindustry?

• Are we actively and productively working with educational institutions at all levels to meethumanresourcerequirements?

• Can we enhance our region’s/nation’s position in biotechnology and can we attract more biotherapeuticmanufacturing?

• How can we improve our capabilities to rapidly develop and manufacture products that willbeneededtoaddressbiodefenseorpandemicthreats?



C h A P t e R 2 : D e M O g R A P h i C S

Survey respondents were a diverse group of biopharmaceutical managers and executives coveringaspectrumofbiopharmaceuticalandCMOfirms.Weincludedfirmsofallsizes,butwespecificallysoughtinputfromlargermanufacturerswithsubstantialcurrentcapacity.Whilerespondents had a broad range of responsibilities, all were involved with manufacturing in some way and most were senior people in their organizations.

This was an international effort, and we received responses from organizations around the world, including input from facilities in 29 different countries. Our partner organizations, BayBio (South San Francisco CA), BioProcessUK (London, United Kingdom) EuropaBIO (Brussels, Bel-gium), and Massachusetts Biotechnology Council (Cambridge, MA), contributed their time and effort to ensure accurate coverage of the worldwide biopharmaceutical industry.

The diversity of respondents provides a unique and comprehensive view of the industry from those closest to the present state of their organizations, with a good understanding of the cur-rent and future business drivers, and manufacturing plans and needs. This provides one of the best means for understanding the current state of the industry and its future course. The break-down of organizations into CMOs and biotherapeutic manufacturers provides insights into the two major segments of the industry; these two types of organizations have different business drivers,riskprofiles,andcostsofcapital.

Chapter 2: Demographics

2.1©2006 BioPlan Associates, Inc . All rights reserved . www .bioplanassociates .com


Area of InvolvementOf the 337 biopharmaceutical manufacturers and contract manufacturing organizations (CMOs) responding to the 2006 survey, 23.4% of respondents were primarily involved in process de-velopmentspecificallyforbiopharmaceuticalmanufacturing;21.1%wereinvolvedprimarilyinscale-up or clinical-scale production. Large-scale cell culture for therapeutics accounted for 16.9%, and large-scale microbial fermentation for therapeutics were 9.2% of respondents. Large-scale contract manufacturers accounted for 11.3%, and 6.8% were involved in vaccine production.

2.2

Fig. 2-1: In which areas of biopharmaceutical manufacturing is your organization currently involved? (N=337)

0% 5% 10% 15% 20% 25%

0% 5% 10% 15% 20% 25%

Other large-scalebiopharmaceutical manufacturing

Vaccine production

Other contract manufacturing(CMO) for biopharmaceuticals

Large-scale microbialfermentation for therapeutics

Large-scale contract manufacturing(CMO) for biopharmaceuticals

Large-scale cell cultureproduction for therapeutics

Scale-up/clinical-scale productionfor biopharmaceuticals

Process Development forbiopharmaceutical manufacturing

0% 5% 10% 15% 20% 25%

0% 5% 10% 15% 20% 25%

Other large-scale biopharmaceutical manufacturing

Vaccine production

Other contract manufacturing (CMO) for biopharmaceuticals

Large-scale microbial fermentation for therapeutics

Large-scale contract manufacturing (CMO) for biopharmaceuticals

Large-scale cell culture production for therapeutics

Scale-up/clinical-scale production for biopharmaceuticals

Process Development for biopharmaceutical manufacturing

23.4%

21.1%

16.9%

11.3%

9.2%

8.0%

6.8%

3.3%



2.3

Respondents’ TitlesRespondents were screened with regard to their areas of responsibility. Process development (PD) managers and scientists made up 21.4% of respondents. VP’s or directors of manufactur-ing accounted for 16.3%. Those directly involved in PD, manufacturing, operations, or engineer-ing made up nearly 63% of the survey respondents.

Fig. 2-2: Which best describes your primary job responsibilities? (N=337)

0.0% 5.0% 10.0% 15.0% 20.0% 25.0%

VP or Director Manufacturing Production 16.3%

Process Development Manager or Scientist 21.4%

VP or Director Marketing, Sales Business Dev. 13.6%

VP or Director R&D 9.5%

VP or Director Operations 8.9%

President / CEO 6.2%

Other Scientist or Engineer 8.0%

Process Engineering 8.3%

VP or Director QA/QC, Validation 6.8%



Facility LocationsNearly 49% of respondents were from the United States, with Europe representing 40% of re-spondents. Other countries represented in the survey included: Canada, Sweden, Switzerland, Denmark, Belgium, Netherlands, India, Austria, France, Ireland, Italy, Portugal, Finland, Aus-tralia, Spain, Korea, Argentina, Puerto Rico, Vietnam, Taiwan, Slovakia, Russia, New Zealand, Malaysia, Czech Republic, and Cuba.

2.4

Fig. 2-3: Where is your facility located?

0% 20% 40% 60% 80% 100%

0% 20% 40% 60% 80% 100%

Others

Argentina

Korea

Spain

Australia

Finland

Portugal

Italy

Ireland

France

Austria

India

Netherlands

Belgium

Denmark

Switzerland

Sweden

Canada

Germany

United Kingdom

US-Southeast

US-Northwest

US-Central

US-Southwest

US-Northeast 85

29

22

18

11

33

25

15

12

10

9

8

6

6

6

5

4

4

4

4

9

3

3

3

2

Fig. 2-4: Respondents' Facility Location, by Region

R.O.W.11%

Europe40%

U.S.49%

Others: Puerto RIco, Vietnam, Taiwan, Slovakia, Russia, New Zealand, Malaysia, Czech Rep., Cuba.



Respondents’ SizeIn terms of size of respondents’ biopharmaceutical manufacturing facilities in 2006, the great-est percentage of respondents (35.9%) had manufacturing staff in the 10–49 person range while nearly 15% of respondents had over 500 employees engaged in biopharmaceutical manufac-turing at their facility. In comparison to the 2005 data, there were relatively fewer small-scale production (1-9 employee) facilities (7.2% in 2006, and 18.6% in 2005). Part of this shift in the size of representative companies in 2006 may have occurred as a result of the survey methodol-ogy and efforts to target larger-scale respondents.

2.5

Fig. 2-5: Number of Employees (Range) Associated with BiopharmaceuticalManufacturing Working at Facility (Percent of Respondents)

0% 5% 10% 15% 20% 25% 30% 35% 40%

0% 5% 10% 15% 20% 25% 30% 35% 40%

Percent in 2005

Percent in 2006

500+

200-499

50-199

10-49

1-9

0% 5% 10% 15% 20% 25% 30% 35% 40%

0% 5% 10% 15% 20% 25% 30% 35% 40%

Percent in 2005

Percent in 2006

500+

200-499

50-199

10-49

1-9

7.2%

18.6%

26.5%

23.0%

15.0%

16.8%

35.9%

25.1%

10.8%

15.0%



Respondents’ Areas of Biopharmaceutical Manufacturing OperationsOver three-quarters of respondents were involved in mammalian cell culture (77%). Sixty-three percent had microbial fermentation production operations. This is similar to the percentages in 2005 (75.5% for mammalian, and 62.0% for microbial systems).

2.6

0% 10% 20% 30% 40% 50% 60% 70% 80%

Mammalian Cell Culture 76.8%

Microbial Fermentation 63.4%

Yeast 29.9%

Insect Cells 14.1%

Plant Cells 3.0%

Other 8.7%

Fig. 2-6: Biopharmaceutical Manufacturing Systems:In which of the following does your organization currently have production operations?


Respondents’ Production Operations, Phase of DevelopmentIn 2006, over two-thirds of respondents (69.0%) had preclinical biopharmaceutical operations, and 44.9% had biopharmaceutical products on the market. In comparison to last year, the number of companies with marketed products rose slightly from 43% to 45%. However, the number of companies with products in R&D declined 13 percentage points, from 73% to 60%. The number of companies with preclinical products declined as well, from 75% in 2005 to 69% in 2006.

2.7


Fig. 2-7: Phase of DevelopmentIn which of the following does your organization currently have products or operations?

0% 10% 20% 30% 40% 50% 60% 70% 80%

year 2006

year 2005

Marketed

Phase III

Phase II

Phase I

Preclinical

R&D60.1%

73.3%

69.0%

75.4%

62.6%

62.3%

63.6%

57.6%

46.5%

51.3%

42.8%

44.9%


A B O u t B i O P l A n A S S O C i A t e S , i n C . BioPlan Associates, Inc., is a biotechnology and life sciences market analysis, research and publishing organization. We have worked with biotechnology, biopharmaceutical, diagnostic, and life sciences companies of all sizes since 1989. Our extensive market analysis, research and management project experience covers biotechnology and biopharmaceutical manufactur-ing, vaccine and therapeutics development, contract research services, diagnostics, devices, biotechnologysupply,physicianofficelabsandhospitallaboratoryenvironments.

Weprovideinformationourclientsrequiretomakeinformedstrategicdecisions,defineobjec-tives, and identify customer needs. Our clients are better able to make informed, market-based decisions because they understand the market and customer needs in high technology indus-tries.

On the training side, our principals and associates teach biotechnology commercialization courses at Johns Hopkins University, American University, and for customized seminars. Pro-grams include: Marketing Technical Products, Marketing Research for Technical Products, ROI/Value Based Selling, Managing Technical People, Pricing Technology, and others.

BioPlan Associates, Inc. 15200 Shady Grove Road, Suite 202Rockville, MD 20850 USAwww.bioplanassociates.com Tel: 301-921-9074

Documents

Biopharmaceutical Manufacturing, Capacity, and … Geoff Hodge, Vice President, Process Development and Technology, Xcellerex Geoffrey Hodge is Vice President, Process Development