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The biotechnology facility: Issues in architectural design Item Type text; Thesis-Reproduction (electronic) Authors Gibson, Janet Stedman, 1942- Publisher The University of Arizona. Rights Copyright © is held by the author. Digital access to this material is made possible by the University Libraries, University of Arizona. Further transmission, reproduction or presentation (such as public display or performance) of protected items is prohibited except with permission of the author. Download date 11/10/2021 04:51:26 Link to Item http://hdl.handle.net/10150/291655 INFORMATION TO USERS The most advanced technology has been used to photograph and reproduce this manuscript from the microfilm master. UMI films the text directly from the original or copy submitted. Thus, some thesis and dissertation copies are in typewriter face, while others may be from any type of computer printer. The quality of this reproduction is dependent upon the quality of the copy submitted. 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Contact UMI directly to order. University Microfilms International A Bell & Howell Information Company 300 North Zeeb Road. Ann Arbor. Ml 48106-1346 USA 313-761-4700 800 521-0600 Order Number 1342470 The biotechnology facility: Issues in architectural design Gibson, Janet Stedman, M.Arch. The University of Arizona, 1990 UMI 300 N. Zeeb Rd. Ann Arbor, MI 48106 THE BIOTECHNOLOGY FACILITY: ISSUES IN ARCHITECTURAL DESIGN by Janet Stedman Gibson A Thesis Submitted to the Faculty of the COLLEGE OF ARCHITECTURE In Partial Fulfillment of the Requirements For the Degree of MASTER OF ARCHITECTURE In the Graduate College THE UNIVERSITY OF ARIZONA 19 9 0 2 STATEMENT BY AUTHOR This thesis has been submitted in partial fulfillment of requirements for an advanced degree at the University of Arizona and is deposited in the University Library to be made available to borrowers under rules of the Library. Brief quotations from this thesis are allowable without special permission, provided that accurate acknowledgment of source is made. Requests for permission for extended quotation from or reproduction of this manuscript in whole or in part may be granted by the head of the major department or the Dean of the Graduate College when in his or her judgment the proposed use of the material is in the interests of scholarship. In all other instances, however, permission must be obtained from the author. APPROVAL BY THESIS DIRECTOR This thesis has been approved on the date shown below: Robert G. Hershberger u Date Dean and Professor College of Architecture 3 ACKNOWLEDGMENTS I would like to express my sincere gratitude to those who made it possible for the research to be undertaken and developed for this project. There is a special debt of gratitude to Dean Robert Hershberger, major advisor and chairman of my thesis committee, for bringing me into the project, for providing direction and for his solid support throughout the development of the study. I wish to thank the other members of my thesis committee for promptly reviewing the draft of the thesis and for contributing valuable suggestions. Professor Thomas Lindell provided fresh perspective through his careful review of the draft of the thesis and helpful recommendations concerning the scientific aspects of the project. Mr. Manuel Marti offered knowledgeable and perceptive insight concerning all aspects of the study. Professor Fred Matter provided many thoughtful comments and his recommendations are greatly appreciated. Although not a member of the committee, Professor David Saile offered helpful guidelines during the early phases of the preparation of the thesis. Special appreciation is extended to Anderson DeBartolo Pan, Inc. and to the University of Arizona Architecture Research Laboratory for providing funding for the various stages of research. In particular, thanks are offered to Mr. Richard Anderson and Dean Robert Hershberger. I was pleased to be a part of the research team with Will Brown, Manuel Marti and Don Yeaman. Their substantial contributions to both the project and my education are gratefully acknowledged (see 2.4 METHODOLOGY and 2.5.3 Research Team). The biotechnology companies/research institutions taking part in the study and the representatives who gave generously of their time are sincerely thanked for providing basic understandings. Participating institutions include Amgen, Inc.; Beckman Center for Molecular and Genetic Medicine, Stanford University; California Biotechnology, Inc.; Chiron Corporation; Collagen Corporation; Genentech, Inc.; and the Salk Institute (see 2.5.2 Site Visits/Expert Industry Informants). Barbara Jardee is gratefully acknowledged for the valuable assistance she provided with word processing. Finally, personal thanks are offered to my husband, Lay, and our sons, Steve and Jim, for their enthusiastic support. TABLE OF CONTENTS 4 Page LIST OF ILLUSTRATIONS 12 LIST OF TABLES 14 ABSTRACT 15 1. EXECUTIVE SUMMARY 16 2. INTRODUCTION 20 2.1 BIOTECHNOLOGY DEFINITION 20 2.2 EMERGING BUILDING TYPE 20 2.3 PURPOSE OF REPORT 23 2.4 METHODOLOGY 24 2.5 RESOURCES 27 2.5.1 Literature Review 27 2.5.1.1 Biotechnology 28 2.5.1.1.1 Scientific Biotechnology 28 2.5.1.1.2 Applied Biotechnology 28 2.5.1.2 General Aspects of Architectural Design 29 2.5.1.2.1 Laboratory Design 30 2.5.1.2.2 Biotechnology Production Facility Design 31 2.5.1.2.3 Warehouse Design 32 2.5.1.2.4 Design of General Support Areas ... 33 2.5.1.3 Examples of Exiting Research Laboratory and Industrial Facilities ... 33 2.5.1.4 Regulations and Guidelines 34 2.5.2 Site Visits/Expert Industry Informants .... 34 2.5.3 Research Team 36 2.5.4 Harvard Seminar 37 2.5.5 University of Arizona Associations 37 3. THE BIOTECHNOLOGY INDUSTRY 39 3.1 INDUSTRIAL APPLICATION 39 3.1.1 Introduction 39 3.1.2 The Biotechnology Company versus the Pharmaceutical Company 39 3.1.3 Multidisciplinarv Aspects 42 3.1.4 Genetic Engineering and Fermentation 43 3.1.5 Monoclonal Antibodies 45 3.1.6 Industrial Activities 46 TABLE OF CONTENTS (continued) 5 Page 3.2 OVERALL BIOTECHNOLOGY PHASES 46 3.2.1 Basic Research 46 3.2.2 Applied Research 48 3.2.3 Development 48 3.2.4 Preclinical Testing 49 3.2.5 Clinical Testing ..... 51 3.2.6 Marketing Research/Marketing 52 3.2.7 Manufacturing 53 3.2.8 Finishing 54 3.2.9 Warehousing/Distribut ion 54 3.3 PRODUCTION PROCESS 54 3.3.1 Product Process 54 3.3.2 Manufacturing Process 56 3.3.2.1 Fermentation 56 3.3.2.2 Downstream Processing 58 3.3.3 Hosts 60 3.3.3.1 Escherichia coli . 61 3.3.3.2 Mammalian Cells 63 3.3.3.3 Yeast 64 3.4 OBSTACLES IN BIOTECHNOLOGY 65 3.4.1 Scale-up 65 3.4.2 Downstream Processing 67 3.5 DEVELOPMENTAL STAGES OF A BIOTECHNOLOGY COMPANY 69 3.5.1 Stage One: Start-up 69 3.5.2 Stage Two: Clinical Testing 72 3.5.3 Stage Three; Manufacturing 73 3.5.4 Stage Four: Finishing 77 3.6 METHODS OF SURVIVAL 78 3.6.1 Operational 78 3.6.1.1 Specialization 78 3.6.1.2 Single Ownership 80 3.6.1.3 Partnership 81 3.6.2 Fund Raising 82 3.6.2.1 Equity Investments/Joint Venture 82 3.6.2.2 Stock Offerings 84 3.6.2.3 Other Methods .... 85 3.7 ORGANIZATION/LABOR FORCE CHARACTERISTICS 85 3.7.1 Organization 85 3.7.2 Labor Force Characteristics 89 3.7.2.1 Employment Categories 89 3.7.2.2 Employment Figures 90 TABLE OF CONTENTS (continued) 6 Page 3.8 LOCATIONAL ISSUES 92 3.9 REGULATORY ISSUES 97 3.9.1 Framework for the Regulation of Biotechnology 99 3.9.2 Federal Authority 100 3.9.2.1 National Institutes of Health (NIH) . 100 3.9.2.2 Food and Drug Administration (FDA) . 103 3.9.2.2.1 Drugs and Biological Products . 104 3.9.2.2.2 Good Manufacturing Practice CGMP) . 104 3.9.2.2.3 FDA Regulatory Process 105 3.9.2.3 Environmental Protection Agency (EPA) . 108 3.9.2.4 United States Department of Agriculture (USDA) 109 3.9.2.5 Occupational Safety and Health Administration (OSHA) 10 9 3.9.2.6 Other Federal Agencies 110 . THE BIOTECHNOLOGY FACILITY Ill 4.1 INTRODUCTION Ill 4.2 RESEARCH FACILITY Ill 4.2.1 Introduction Ill 4.2.2 Laboratories 112 4.2.2.1 Laboratory Module 113 4.2.2.1.1 Determinants 114 4.2.2.1.2 Ergonomics 115 4.2.2.1.3 Laboratory Space Norms 118 4.2.2.1.4 Modules Observed 120 4.2.2.2 Laboratory Types 125 4.2.2.2.1 Observation of Laboratory Types . 127 4.2.2.2.1.1 Laboratories by Type of Science 127 4.2.2.2.1.2 Standard Laboratories 132 4.2.2.2.1.3 Open Versus Closed Laboratories 134 4.2.2.2.2 Biosafetv Laboratories 136 4.2.2.2.2.1 Biosafety Level 1 Laboratories 139 4.2.2.2.2.2 Biosafety Level 2 Laboratories 140 4.2.2.2.2.3 Biosafety Level 3 Laboratories 140 4.2.2.2.2.4 Biosafety Level 4 Laboratories 142 4.2.2.2.3 Clean Room Laboratories 143 4.2.2.3 Laboratory Casework 146 4.2.2.3.1 General Considerations 146 4.2.2.3.2 Elements/Dimensions 147 4.2.2.3.2.1 Laboratory Bench 147 4.2.2.3.2.2 Shelving/Wall Cabinets 150 4.2.2.3.2.3 Base Cabinets 151 TABLE OF CONTENTS (continued) 7 Page 4.2.2.3.2.4 Miscellaneous Casework 153 4.2.2.3.3 Casework Layout 154 4.2.2.3.3.1 Clarity of Aisle/Bench Layout .