The Biotech Business Handbook: How to Organize and Operate a Biotechnology Business, Including the Most Promising Applications for the 1990s
Autor Michael G. Pappasen Limba Engleză Paperback – iun 1994
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Specificații
ISBN-13: 9780896033207
ISBN-10: 0896033201
Pagini: 461
Ilustrații: XVIII, 461 p.
Dimensiuni: 216 x 279 x 28 mm
Greutate: 1.11 kg
Ediția:Softcover reprint of the original 1st ed. 1994
Editura: Humana Press Inc.
Colecția Humana
Locul publicării:Totowa, NJ, United States
ISBN-10: 0896033201
Pagini: 461
Ilustrații: XVIII, 461 p.
Dimensiuni: 216 x 279 x 28 mm
Greutate: 1.11 kg
Ediția:Softcover reprint of the original 1st ed. 1994
Editura: Humana Press Inc.
Colecția Humana
Locul publicării:Totowa, NJ, United States
Public țintă
ResearchCuprins
Preface.- List of Tables.- List of Figures.- 1 The World Biotechnology Industry.- The Ancients and Fermentation Science.- More Recent Advances.- Chronology.- Research and Development.- Foreign Governments and Corporations.- Summary.- Pertinent Reading.- 2 Preparing to Enter the Biotechnology Industry.- Biotechnology Programs.- Cooperative Education.- Groomed for the Job.- Employment Opportunities in the Next Decade.- Summary.- Pertinent Reading.- 3 Corporate Organization.- Noncorporate Businesses.- Corporations.- Indemnification.- Summary.- Pertinent Reading.- 4 Management Considerations.- Management Structure.- Research and Development.- Confidentiality.- Great Scientist, Terrible Manager.- Transition.- Crisis Management.- Summary.- Pertinent Reading.- 5 Legal Issues in Biotechnology.- Patents.- Patent Laws.- Patent Application Components.- Trade Secrets.- Trademarks.- Corporate Identity.- Summary.- Pertinent Reading.- 6 Biotechnology Funding.- Funding Sources.- Strategic Alliances.- Spinoffs.- Consolidation.- Pitfalls of Consolidation.- Private Placement.- Venture Capital.- Syndication.- Government Contracts.- Government Grants.- Human Subjects.- Summary.- Pertinent Reading.- 7 Biotechnology Project Development.- Informal Project Development.- Formal Project Development.- Project Review.- Prototypes.- Summary.- Pertinent Reading.- 8 Biotechnology Product Development.- Prioritizing Projects.- Product Development.- Summary.- Pertinent Reading.- 9 Quality Control.- Types of Quality Control Tests.- Sampling.- Stability.- Methods for Determining the Stability of Assay Components.- Summary.- Pertinent Reading.- 10 Quality Assurance.- Specifications Development.- Trend Analysis.- Stability Testing.- Current Good Manufacturing Practices (cGMP).- Freedom of Information Act (FOIA).- Summary.- Pertinent Reading.- 1 1 Manufacturing.- Manufacturing Facilities.- Manufacturing Process.- Summary.- Pertinent Reading.- 12 Regulatory Compliance.- Device Classifications.- Current Good Manufacturing Practices (cGMP).- Critical Devices.- Medical Device Reporting Regulation (MDR).- Premarket Approval (PMA).- PMA Format.- Safe Medical Devices Act.- Drug Approval.- Medical Device Export.- Chemical Diversion and Trafficking.- Summary.- Pertinent Reading.- 13 Marketing the Technology.- Targetting the Right Customer.- Marketing Studies.- Demand.- Supply.- Side-by-Side Comparisons.- Scientific Approval.- Advertising.- Quality.- Sales Representation.- Deceptive Advertising.- Summary.- Pertinent Reading.- 14 Troubleshooting Products After Release.- Customer Service.- Product Bulletins.- Product Recalls.- Summary.- Pertinent Reading.- 15 Safety in the Biotechnology Workplace.- Health and Surveillance Programs.- Laboratory Accidents.- OSHA.- Emergency Equipment.- Material Safety Data Sheet (MSDS).- Hazardous and Toxic Waste Regulations.- Drug-Free Workplace.- Equipment.- Summary.- Pertinent Reading.- 16 Support Services and Facilities.- Accounting.- Legal Counsel.- Facilities Maintenance.- Secretarial.- Security.- Warehouse/Annex.- Summary.- Pertinent Reading.- 17 Immunodiagnostic Assays.- Monoclonal Antibodies.- Analyte Detection.- Immunoassay Formats.- Direct Immunoassays.- Indirect Immunoassays.- Antibody-Based Assays.- Rapid Test Kits.- Summary.- Pertinent Reading.- 18 Nucleic Acid Probe Assays.- Nucleic Acids.- Tools Used in Recombinant Protein Development.- DNA Probe Assays.- Commercial Kits.- Summary.- Pertinent Reading.- 19 Human Genome Initiative.- Model Organism Genomes.- Information Technology.- Controversial Issues Regarding the Human Genome Project.- Collaborations.- Technology Transfer.- Summary.- Pertinent Reading.- 20 Bioremediation.- Scope of the Problem.- Recycling.- Environmental Remediation.- Bioremediation.- In Situ Bioremediation.- Regulatory Issues.- Biodegradation.- Summary.- Pertinent Reading.- 21 Gene Therapy Biotechnology.- Gene Therapy.- Guidelines.- Future Prospects.- Summary.- Pertinent Reading.- 22 The Biotechnology of Transgenics.- How Transgenics Works.- Production of Transgenic Animals.- Commercial Potential of Transgenic Animals.- Guidelines.- Chimerics.- Transgenic Plants.- Transgenic Fish.- Summary.- Pertinent Reading.- 23 Vaccine, Drug, Antisense, and Third-Strand Therapies.- Eradication Versus Control.- Revival in Vaccine Research.- Vaccine Development.- Recombinant Vaccines and Drug Treatments.- Strategic Partnering.- Hurdles to Successful Antisense Therapy.- Summary.- Pertinent Reading.- 24 Allografts, Artificial Tissues, and Organs.- Osteogenesis.- Allografts.- Controlled Drug Delivery.- Artificial Organs.- Diabetes.- Summary.- Pertinent Reading.- ApPENDIX I. ADDRESSES OF PUBLIC HEALTH SERVICE SBIR CONTRACT OFFICIALS.- ApPENDIX II. ADDRESSES OF PUBLIC HEALTH SERVICE SBIR GRANT OFFICIALS.- pPENDIX III. ABBREVIATIONS AND ACRONYMS.
Recenzii
...effectively brings together the many diverse elements that comprise the building of a biotechnology company...a very useful compendium of information that should find its place in the library of every biotech/venture capital company...may help many a new company...-Drug Development Research