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Biotech funding trends [[electronic resource] ] : insights from entrepreneurs and investors / / Alexandra Carina Gruber
| Biotech funding trends [[electronic resource] ] : insights from entrepreneurs and investors / / Alexandra Carina Gruber |
| Autore | Gruber Alexandra Carina <1971-> |
| Pubbl/distr/stampa | Weinheim, : Wiley-Blackwell, c2009 |
| Descrizione fisica | 1 online resource (212 p.) |
| Disciplina |
228.4/36606094
338.476606 |
| Soggetto topico |
Biotechnology industries - Europe - Finance
Biotechnology - Europe |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-282-68309-8
9786612683091 3-527-62273-X 3-527-62274-8 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Biotech Funding Trends: Insights from Entrepreneurs and Investors; Contents; Preface; Acknowledgments; Limit of Liability/Disclaimer of Warranty; Executive Summary; 1 Introduction; 1.1 Development of the Private Equity and Venture Capital Market; 1.1.1 Denition; 1.1.2 Historical Background; 1.1.3 The Challenges to Private Equity in Europe; 1.1.4 Private Equity and Venture Capital Performance in Europe by Country; 1.1.5 The Future of Private Equity and Venture Capital in Europe; 1.2 Development of the Biotech Industry; 1.2.1 Definition; 1.2.2 Historical Background
1.2.3 Financing Biotech Start-ups1.2.4 Exit Routes in the Biotech Industry; 1.2.5 The Challenges to European Biotech; 1.2.6 The Future of the European Biotech Industry; 2 Methodology; 2.1 Formulating the Research Goal; 2.1.1 The Entrepreneur's Dilemma; 2.1.2 The Investor's Dilemma; 2.1.3 Financing Models; 2.1.4 Interpersonal Relationships and Cooperations; 2.1.5 Practical Guidelines for Entrepreneurs and Venture Capitalists; 2.2 Conducting the Study; 2.2.1 Qualitative Interviews; 2.2.2 Selection of Interview Partners; 2.3 Evaluating the Results; 3 Data Analysis and Interpretation of Results 3.1 Description of Interview Partners3.1.1 Entrepreneurs; 3.1.2 Venture Capitalists; 3.1.3 Other Investors; 3.2 Major Characteristics of an Entrepreneur; 3.2.1 The Dual Role of the Entrepreneur; 3.3 Major Characteristics of a Venture Capitalist; 3.3.1 Global Reach of the Fund; 3.4 The Most Important Partnering Criteria; 3.4.1 The Entrepreneur's Perspective; 3.4.2 The Venture Capitalist's Perspective; 3.4.3 The Perspective of Other Investors; 3.5 Financing Models; 3.5.1 Most Important Financing Models; 3.5.2 New and Creative Financing Approaches 3.5.3 Differences Between Early- and Late-stage Financing3.5.4 Differences Between Early- and Late-stage Valuation Techniques; 3.6 Biotech Research Areas; 3.6.1 Vaccines; 3.6.2 Biotech Drug Development or Medical Technology and Devices?; 3.7 Alliances and Funding in the Early Stage; 3.7.1 Networking Between Venture Capitalists and Universities and Their Scientists; 3.7.2 The Role of Government Grants; 3.7.3 The Role of Business Angels; 3.7.4 Preferred Deal Structure; 3.7.5 Structuring the Board of Directors; 3.8 Alliances and Funding in the Late Stage 3.8.1 Networking with Corporate Venture Capitalists3.8.2 The Role of Banks as Capital Investors; 3.8.3 The Importance of Milestone Payments; 3.9 Exit Routes; 3.9.1 Exit Preferences; 3.9.2 The Role of New Markets; 3.9.3 Prominent European IPO Success Stories; 3.10 Primary Causes of Failure; 3.10.1 The Entrepreneur's Perspective; 3.10.2 The Venture Capitalist's Perspective; 3.10.3 The Perspective of Other Investors; 3.11 Best-practice Countries for Funding Biotech Start-ups; 3.11.1 The Entrepreneur's Perspective; 3.11.2 The Venture Capitalist's Perspective 3.11.3 The Perspective of Other Investors |
| Record Nr. | UNINA-9910145252003321 |
Gruber Alexandra Carina <1971->
|
||
| Weinheim, : Wiley-Blackwell, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Biotech funding trends [[electronic resource] ] : insights from entrepreneurs and investors / / Alexandra Carina Gruber
| Biotech funding trends [[electronic resource] ] : insights from entrepreneurs and investors / / Alexandra Carina Gruber |
| Autore | Gruber Alexandra Carina <1971-> |
| Pubbl/distr/stampa | Weinheim, : Wiley-Blackwell, c2009 |
| Descrizione fisica | 1 online resource (212 p.) |
| Disciplina |
228.4/36606094
338.476606 |
| Soggetto topico |
Biotechnology industries - Europe - Finance
Biotechnology - Europe |
| ISBN |
1-282-68309-8
9786612683091 3-527-62273-X 3-527-62274-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Biotech Funding Trends: Insights from Entrepreneurs and Investors; Contents; Preface; Acknowledgments; Limit of Liability/Disclaimer of Warranty; Executive Summary; 1 Introduction; 1.1 Development of the Private Equity and Venture Capital Market; 1.1.1 Denition; 1.1.2 Historical Background; 1.1.3 The Challenges to Private Equity in Europe; 1.1.4 Private Equity and Venture Capital Performance in Europe by Country; 1.1.5 The Future of Private Equity and Venture Capital in Europe; 1.2 Development of the Biotech Industry; 1.2.1 Definition; 1.2.2 Historical Background
1.2.3 Financing Biotech Start-ups1.2.4 Exit Routes in the Biotech Industry; 1.2.5 The Challenges to European Biotech; 1.2.6 The Future of the European Biotech Industry; 2 Methodology; 2.1 Formulating the Research Goal; 2.1.1 The Entrepreneur's Dilemma; 2.1.2 The Investor's Dilemma; 2.1.3 Financing Models; 2.1.4 Interpersonal Relationships and Cooperations; 2.1.5 Practical Guidelines for Entrepreneurs and Venture Capitalists; 2.2 Conducting the Study; 2.2.1 Qualitative Interviews; 2.2.2 Selection of Interview Partners; 2.3 Evaluating the Results; 3 Data Analysis and Interpretation of Results 3.1 Description of Interview Partners3.1.1 Entrepreneurs; 3.1.2 Venture Capitalists; 3.1.3 Other Investors; 3.2 Major Characteristics of an Entrepreneur; 3.2.1 The Dual Role of the Entrepreneur; 3.3 Major Characteristics of a Venture Capitalist; 3.3.1 Global Reach of the Fund; 3.4 The Most Important Partnering Criteria; 3.4.1 The Entrepreneur's Perspective; 3.4.2 The Venture Capitalist's Perspective; 3.4.3 The Perspective of Other Investors; 3.5 Financing Models; 3.5.1 Most Important Financing Models; 3.5.2 New and Creative Financing Approaches 3.5.3 Differences Between Early- and Late-stage Financing3.5.4 Differences Between Early- and Late-stage Valuation Techniques; 3.6 Biotech Research Areas; 3.6.1 Vaccines; 3.6.2 Biotech Drug Development or Medical Technology and Devices?; 3.7 Alliances and Funding in the Early Stage; 3.7.1 Networking Between Venture Capitalists and Universities and Their Scientists; 3.7.2 The Role of Government Grants; 3.7.3 The Role of Business Angels; 3.7.4 Preferred Deal Structure; 3.7.5 Structuring the Board of Directors; 3.8 Alliances and Funding in the Late Stage 3.8.1 Networking with Corporate Venture Capitalists3.8.2 The Role of Banks as Capital Investors; 3.8.3 The Importance of Milestone Payments; 3.9 Exit Routes; 3.9.1 Exit Preferences; 3.9.2 The Role of New Markets; 3.9.3 Prominent European IPO Success Stories; 3.10 Primary Causes of Failure; 3.10.1 The Entrepreneur's Perspective; 3.10.2 The Venture Capitalist's Perspective; 3.10.3 The Perspective of Other Investors; 3.11 Best-practice Countries for Funding Biotech Start-ups; 3.11.1 The Entrepreneur's Perspective; 3.11.2 The Venture Capitalist's Perspective 3.11.3 The Perspective of Other Investors |
| Record Nr. | UNINA-9910830703703321 |
|
Gruber Alexandra Carina <1971->
|
||
| Weinheim, : Wiley-Blackwell, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Biotech funding trends [[electronic resource] ] : insights from entrepreneurs and investors / / Alexandra Carina Gruber
| Biotech funding trends [[electronic resource] ] : insights from entrepreneurs and investors / / Alexandra Carina Gruber |
| Autore | Gruber Alexandra Carina <1971-> |
| Pubbl/distr/stampa | Weinheim, : Wiley-Blackwell, c2009 |
| Descrizione fisica | 1 online resource (212 p.) |
| Disciplina |
228.4/36606094
338.476606 |
| Soggetto topico |
Biotechnology industries - Europe - Finance
Biotechnology - Europe |
| ISBN |
1-282-68309-8
9786612683091 3-527-62273-X 3-527-62274-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Biotech Funding Trends: Insights from Entrepreneurs and Investors; Contents; Preface; Acknowledgments; Limit of Liability/Disclaimer of Warranty; Executive Summary; 1 Introduction; 1.1 Development of the Private Equity and Venture Capital Market; 1.1.1 Denition; 1.1.2 Historical Background; 1.1.3 The Challenges to Private Equity in Europe; 1.1.4 Private Equity and Venture Capital Performance in Europe by Country; 1.1.5 The Future of Private Equity and Venture Capital in Europe; 1.2 Development of the Biotech Industry; 1.2.1 Definition; 1.2.2 Historical Background
1.2.3 Financing Biotech Start-ups1.2.4 Exit Routes in the Biotech Industry; 1.2.5 The Challenges to European Biotech; 1.2.6 The Future of the European Biotech Industry; 2 Methodology; 2.1 Formulating the Research Goal; 2.1.1 The Entrepreneur's Dilemma; 2.1.2 The Investor's Dilemma; 2.1.3 Financing Models; 2.1.4 Interpersonal Relationships and Cooperations; 2.1.5 Practical Guidelines for Entrepreneurs and Venture Capitalists; 2.2 Conducting the Study; 2.2.1 Qualitative Interviews; 2.2.2 Selection of Interview Partners; 2.3 Evaluating the Results; 3 Data Analysis and Interpretation of Results 3.1 Description of Interview Partners3.1.1 Entrepreneurs; 3.1.2 Venture Capitalists; 3.1.3 Other Investors; 3.2 Major Characteristics of an Entrepreneur; 3.2.1 The Dual Role of the Entrepreneur; 3.3 Major Characteristics of a Venture Capitalist; 3.3.1 Global Reach of the Fund; 3.4 The Most Important Partnering Criteria; 3.4.1 The Entrepreneur's Perspective; 3.4.2 The Venture Capitalist's Perspective; 3.4.3 The Perspective of Other Investors; 3.5 Financing Models; 3.5.1 Most Important Financing Models; 3.5.2 New and Creative Financing Approaches 3.5.3 Differences Between Early- and Late-stage Financing3.5.4 Differences Between Early- and Late-stage Valuation Techniques; 3.6 Biotech Research Areas; 3.6.1 Vaccines; 3.6.2 Biotech Drug Development or Medical Technology and Devices?; 3.7 Alliances and Funding in the Early Stage; 3.7.1 Networking Between Venture Capitalists and Universities and Their Scientists; 3.7.2 The Role of Government Grants; 3.7.3 The Role of Business Angels; 3.7.4 Preferred Deal Structure; 3.7.5 Structuring the Board of Directors; 3.8 Alliances and Funding in the Late Stage 3.8.1 Networking with Corporate Venture Capitalists3.8.2 The Role of Banks as Capital Investors; 3.8.3 The Importance of Milestone Payments; 3.9 Exit Routes; 3.9.1 Exit Preferences; 3.9.2 The Role of New Markets; 3.9.3 Prominent European IPO Success Stories; 3.10 Primary Causes of Failure; 3.10.1 The Entrepreneur's Perspective; 3.10.2 The Venture Capitalist's Perspective; 3.10.3 The Perspective of Other Investors; 3.11 Best-practice Countries for Funding Biotech Start-ups; 3.11.1 The Entrepreneur's Perspective; 3.11.2 The Venture Capitalist's Perspective 3.11.3 The Perspective of Other Investors |
| Record Nr. | UNINA-9910841167403321 |
|
Gruber Alexandra Carina <1971->
|
||
| Weinheim, : Wiley-Blackwell, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Biotechnology Business - Concept to Delivery [[electronic resource] /] / edited by Arpita Saxena
| Biotechnology Business - Concept to Delivery [[electronic resource] /] / edited by Arpita Saxena |
| Edizione | [1st ed. 2020.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2020 |
| Descrizione fisica | 1 online resource (XVI, 193 p. 34 illus., 24 illus. in color.) |
| Disciplina | 338.476606 |
| Collana | EcoProduction, Environmental Issues in Logistics and Manufacturing |
| Soggetto topico |
Environmental engineering
Biotechnology Sustainable development Urban geography Sociology, Urban Environmental Engineering/Biotechnology Sustainable Development Urban Geography / Urbanism (inc. megacities, cities, towns) Urban Studies/Sociology |
| ISBN | 3-030-36130-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910377839203321 |
| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2020 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Career options in the pharmaceutical and biomedical industry : an insider's guide / / Josse R. Thomas, Luciano Saso, Chris F.H. van Schravendijk, editors
| Career options in the pharmaceutical and biomedical industry : an insider's guide / / Josse R. Thomas, Luciano Saso, Chris F.H. van Schravendijk, editors |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Cham, Switzerland : , : Springer, , [2023] |
| Descrizione fisica | 1 online resource (334 pages) |
| Disciplina | 338.476606 |
| Soggetto topico |
Biotechnology industries
Biotechnology industries - Vocational guidance Pharmaceutical industry - Vocational guidance |
| ISBN | 3-031-14911-4 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Part 1: Setting the scene -- Chapter 1: Life after Academia: Launching your Pharma/Biotech Career -- Chapter 2: Competences for Pharmacists -- Chapter 3: Job and Career Opportunities in the Pharmaceutical Industry: An Overview -- Part 2: Opportunities along the drug/product life cycle -- Chapter 4: Career Opportunities in Toxicology -- Chapter 5: Job Possibilities in Clinical Research -- Chapter 6: How to Get and Develop a Career in a Market Access Role in the Medical Devices Industry -- Chapter 7: Job Opportunities in Pharmaceutical Marketing -- Chapter 8: Working in Medical Affairs and Clinical Operations: Life-Changing Careers -- Chapter 9: The Role of Medical Science Liaison -- Chapter 10: Career Development for Physicians in the Biopharmaceutical Industry -- Part 3: Opportunities in Supportive Functions -- Chapter 11: Job and Career Opportunities in Regulatory Affairs/Science -- Chapter 12: Job Opportunities in Clinical Research Quality Assurance -- Chapter 13: Job Opportunities in Quality Assurance Related to Manufacturing of Medicinal Products -- Part 4: Other Opportunities in the Pharmaceutical and Biomedical Sector -- Chapter 14: Careers Perspective in a Science and Technology Park -- Chapter 15: To be or not to be: Entrepreneurship and Enterprise Creation as a Way to Innovate in Life Sciences -- Chapter 16: How to Become a Successful Hospital and Community Pharmacist -- Part 5: Practical tips and tricks -- Chapter 17: A Successful Career in the Life Sciences Industry: How to Write your Strongest Resumé and Ace that Interview -- Chapter 18: Skill Building for Career Advancement: Public Speaking and Networking -- Chapter 19: Training Opportunities for a Career in the Pharmaceutical and Biomedical Industry/Sector. |
| Record Nr. | UNINA-9910647777903321 |
| Cham, Switzerland : , : Springer, , [2023] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Emprender en biotecnología : del laboratorio al mercado de capitales / / Pilar de la Huerta
| Emprender en biotecnología : del laboratorio al mercado de capitales / / Pilar de la Huerta |
| Autore | De la Huerta Pilar |
| Pubbl/distr/stampa | Madrid : , : LID Editorial, , [2021] |
| Descrizione fisica | 1 online resource (91 pages) |
| Disciplina | 338.476606 |
| Soggetto topico |
Biotechnology industries
New business enterprises |
| ISBN | 84-18757-06-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | spa |
| Record Nr. | UNINA-9910795611803321 |
|
De la Huerta Pilar
|
||
| Madrid : , : LID Editorial, , [2021] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Emprender en biotecnología : del laboratorio al mercado de capitales / / Pilar de la Huerta
| Emprender en biotecnología : del laboratorio al mercado de capitales / / Pilar de la Huerta |
| Autore | De la Huerta Pilar |
| Pubbl/distr/stampa | Madrid : , : LID Editorial, , [2021] |
| Descrizione fisica | 1 online resource (91 pages) |
| Disciplina | 338.476606 |
| Soggetto topico |
Biotechnology industries
New business enterprises |
| ISBN | 84-18757-06-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | spa |
| Record Nr. | UNINA-9910811313803321 |
|
De la Huerta Pilar
|
||
| Madrid : , : LID Editorial, , [2021] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidelines for process safety in bioprocess manufacturing facilities [[electronic resource] /] / Center for Chemical Process Safety
| Guidelines for process safety in bioprocess manufacturing facilities [[electronic resource] /] / Center for Chemical Process Safety |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-AIChE, 2011 |
| Descrizione fisica | 1 online resource (248 p.) |
| Disciplina |
338.476606
660.6028/9 |
| Soggetto topico | Biochemical engineering - Safety measures |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-118-00900-2
1-282-94392-8 9786612943928 0-470-94914-7 1-61583-628-4 0-470-94913-9 |
| Classificazione | TEC009010 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Guidelines for Process Safety in Bioprocess Manufacturing Facilities; CONTENTS; List of Tables; List of Figures; Items on the Web Accompanying This Book; Acknowledgements; Preface; 1 INTRODUCTION; 1.1 Bioprocess Engineering Information Transfer and Management Practices; 1.2 The Need for Bioprocess Safely Management Systems; 1.2.2 Bioprocessing Incidents and Releases; 1.3 Our Target Audience; 1.4 How to use this Guideline; 2 AN OVERVIEW OF THE BIOPROCESSING INDUSTRY; 2.1 Bioprocessing's History; 2.1.1 Bioprocessing's Historical Advancement; 2.1.1.1 Microbiological Advancements
2.1.1.2 Food Science and Food Process Technology Advancements2.1.1.3 Genetic Advancements; 2.1.1.4 Future Bioprocessing Developments; 2.2 Industrial Applications; 2.2.1 Processes; 2.2.2 Products; 2.3 The Bioprocess Lifecycle; 2.3.1 Discovery; 2.3.2 Development Phase: Laboratory and Pilot Plant; 2.3.3 Scale-up Phase; 2.3.4 Upstream Operations and Downstream Operations; 2.3.4.1 Inoculation / Seed and Production Biosafety Containment and Production Risk; 2.3.4.2 Fermentation / Cell Culture; 2.3.4.3 Scale of Manufacturing; 2.3.5 General Biosafety Recommendations for Large Scale Work 2.3.5.1 Facility Design2.3.5.2 Equipment Design; 2.3.5.3 Cleaning, Inactivation, and Sterilization; 2.3.5.4 Maintenance; 2.3.5.5 Air and Gas Emissions; 2.3.5.6 Waste Handling; 2.3.5.7 Accidental Release; 2.3.6 Product Safety Information; 2.3.6.1 Product Handling; 2.3.6.2 Material Disposal; 2.3.6.3 Disposable Process Technology; 2.3.7 Outsourced Manufacturing Concerns; 3 BIOPROCESSING SAFETY MANAGEMENT PRACTICES; 3.1 Sample Approach; 3.1.2 Develop and Document a System to Manage Bioprocess Safety Hazards; 3.1.3 Appoint a Biological Safety Officer; 3.1.4 Collect Bioprocess Hazard Information 3.1.5 Identify Bioprocess Safety Hazards3.1.5.1 Point of Decision; 3.1.6 Assess Bioprocess Safety Risks and Assign Bioprocess Safety Hazard Level; 3.1.7 Identify Bioprocess Controls and Risk Management Options; 3.1.8 Document Bioprocess Safety Hazard Risks and Management Decisions; 3.1.9 Communicate and Train on Bioprocess Safety Hazards; 3.1.10 Investigate & Learn from Bioprocess Incidents; 3.1.11 Review, Audit, Manage Change, and Improve Hazard Management Practices and Program; 3.2 Existing Management Systems; 3.2.1 Product Stewardship for Bioproducts 3.3 Establishing a Bioprocess Safety Management System3.3.1 Select a Management System Model Based Upon Your Needs; 3.3.2 Identifying the Elements that Apply to Your Operations; 3.3.3 Establish a Review and Approval Cycle for the Documents; 3.3.4 Rolling Out the Management System to the Users; 3.4 Biosafety Training for the Workforce; 3.5 Investigating Incidents; 3.5.1 A Generic Procedure for Initial Biohazard Incident Response; 3.6 Managing Change; 3.7 Reviewing and Auditing for Continuous Improvement; 3.8 Applying Behavior-Based Safety to Bioprocesses; 4 IDENTIFYING BIOPROCESS HAZARDS 4.1 Key Considerations for Assessing Risk to Manage Bioprocess Safety |
| Record Nr. | UNINA-9910141041303321 |
| Hoboken, N.J., : Wiley-AIChE, 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidelines for process safety in bioprocess manufacturing facilities [[electronic resource] /] / Center for Chemical Process Safety
| Guidelines for process safety in bioprocess manufacturing facilities [[electronic resource] /] / Center for Chemical Process Safety |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-AIChE, 2011 |
| Descrizione fisica | 1 online resource (248 p.) |
| Disciplina |
338.476606
660.6028/9 |
| Soggetto topico | Biochemical engineering - Safety measures |
| ISBN |
1-118-00900-2
1-282-94392-8 9786612943928 0-470-94914-7 1-61583-628-4 0-470-94913-9 |
| Classificazione | TEC009010 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Guidelines for Process Safety in Bioprocess Manufacturing Facilities; CONTENTS; List of Tables; List of Figures; Items on the Web Accompanying This Book; Acknowledgements; Preface; 1 INTRODUCTION; 1.1 Bioprocess Engineering Information Transfer and Management Practices; 1.2 The Need for Bioprocess Safely Management Systems; 1.2.2 Bioprocessing Incidents and Releases; 1.3 Our Target Audience; 1.4 How to use this Guideline; 2 AN OVERVIEW OF THE BIOPROCESSING INDUSTRY; 2.1 Bioprocessing's History; 2.1.1 Bioprocessing's Historical Advancement; 2.1.1.1 Microbiological Advancements
2.1.1.2 Food Science and Food Process Technology Advancements2.1.1.3 Genetic Advancements; 2.1.1.4 Future Bioprocessing Developments; 2.2 Industrial Applications; 2.2.1 Processes; 2.2.2 Products; 2.3 The Bioprocess Lifecycle; 2.3.1 Discovery; 2.3.2 Development Phase: Laboratory and Pilot Plant; 2.3.3 Scale-up Phase; 2.3.4 Upstream Operations and Downstream Operations; 2.3.4.1 Inoculation / Seed and Production Biosafety Containment and Production Risk; 2.3.4.2 Fermentation / Cell Culture; 2.3.4.3 Scale of Manufacturing; 2.3.5 General Biosafety Recommendations for Large Scale Work 2.3.5.1 Facility Design2.3.5.2 Equipment Design; 2.3.5.3 Cleaning, Inactivation, and Sterilization; 2.3.5.4 Maintenance; 2.3.5.5 Air and Gas Emissions; 2.3.5.6 Waste Handling; 2.3.5.7 Accidental Release; 2.3.6 Product Safety Information; 2.3.6.1 Product Handling; 2.3.6.2 Material Disposal; 2.3.6.3 Disposable Process Technology; 2.3.7 Outsourced Manufacturing Concerns; 3 BIOPROCESSING SAFETY MANAGEMENT PRACTICES; 3.1 Sample Approach; 3.1.2 Develop and Document a System to Manage Bioprocess Safety Hazards; 3.1.3 Appoint a Biological Safety Officer; 3.1.4 Collect Bioprocess Hazard Information 3.1.5 Identify Bioprocess Safety Hazards3.1.5.1 Point of Decision; 3.1.6 Assess Bioprocess Safety Risks and Assign Bioprocess Safety Hazard Level; 3.1.7 Identify Bioprocess Controls and Risk Management Options; 3.1.8 Document Bioprocess Safety Hazard Risks and Management Decisions; 3.1.9 Communicate and Train on Bioprocess Safety Hazards; 3.1.10 Investigate & Learn from Bioprocess Incidents; 3.1.11 Review, Audit, Manage Change, and Improve Hazard Management Practices and Program; 3.2 Existing Management Systems; 3.2.1 Product Stewardship for Bioproducts 3.3 Establishing a Bioprocess Safety Management System3.3.1 Select a Management System Model Based Upon Your Needs; 3.3.2 Identifying the Elements that Apply to Your Operations; 3.3.3 Establish a Review and Approval Cycle for the Documents; 3.3.4 Rolling Out the Management System to the Users; 3.4 Biosafety Training for the Workforce; 3.5 Investigating Incidents; 3.5.1 A Generic Procedure for Initial Biohazard Incident Response; 3.6 Managing Change; 3.7 Reviewing and Auditing for Continuous Improvement; 3.8 Applying Behavior-Based Safety to Bioprocesses; 4 IDENTIFYING BIOPROCESS HAZARDS 4.1 Key Considerations for Assessing Risk to Manage Bioprocess Safety |
| Record Nr. | UNINA-9910830128403321 |
| Hoboken, N.J., : Wiley-AIChE, 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidelines for process safety in bioprocess manufacturing facilities [[electronic resource] /] / Center for Chemical Process Safety
| Guidelines for process safety in bioprocess manufacturing facilities [[electronic resource] /] / Center for Chemical Process Safety |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-AIChE, 2011 |
| Descrizione fisica | 1 online resource (248 p.) |
| Disciplina |
338.476606
660.6028/9 |
| Soggetto topico | Biochemical engineering - Safety measures |
| ISBN |
1-118-00900-2
1-282-94392-8 9786612943928 0-470-94914-7 1-61583-628-4 0-470-94913-9 |
| Classificazione | TEC009010 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Guidelines for Process Safety in Bioprocess Manufacturing Facilities; CONTENTS; List of Tables; List of Figures; Items on the Web Accompanying This Book; Acknowledgements; Preface; 1 INTRODUCTION; 1.1 Bioprocess Engineering Information Transfer and Management Practices; 1.2 The Need for Bioprocess Safely Management Systems; 1.2.2 Bioprocessing Incidents and Releases; 1.3 Our Target Audience; 1.4 How to use this Guideline; 2 AN OVERVIEW OF THE BIOPROCESSING INDUSTRY; 2.1 Bioprocessing's History; 2.1.1 Bioprocessing's Historical Advancement; 2.1.1.1 Microbiological Advancements
2.1.1.2 Food Science and Food Process Technology Advancements2.1.1.3 Genetic Advancements; 2.1.1.4 Future Bioprocessing Developments; 2.2 Industrial Applications; 2.2.1 Processes; 2.2.2 Products; 2.3 The Bioprocess Lifecycle; 2.3.1 Discovery; 2.3.2 Development Phase: Laboratory and Pilot Plant; 2.3.3 Scale-up Phase; 2.3.4 Upstream Operations and Downstream Operations; 2.3.4.1 Inoculation / Seed and Production Biosafety Containment and Production Risk; 2.3.4.2 Fermentation / Cell Culture; 2.3.4.3 Scale of Manufacturing; 2.3.5 General Biosafety Recommendations for Large Scale Work 2.3.5.1 Facility Design2.3.5.2 Equipment Design; 2.3.5.3 Cleaning, Inactivation, and Sterilization; 2.3.5.4 Maintenance; 2.3.5.5 Air and Gas Emissions; 2.3.5.6 Waste Handling; 2.3.5.7 Accidental Release; 2.3.6 Product Safety Information; 2.3.6.1 Product Handling; 2.3.6.2 Material Disposal; 2.3.6.3 Disposable Process Technology; 2.3.7 Outsourced Manufacturing Concerns; 3 BIOPROCESSING SAFETY MANAGEMENT PRACTICES; 3.1 Sample Approach; 3.1.2 Develop and Document a System to Manage Bioprocess Safety Hazards; 3.1.3 Appoint a Biological Safety Officer; 3.1.4 Collect Bioprocess Hazard Information 3.1.5 Identify Bioprocess Safety Hazards3.1.5.1 Point of Decision; 3.1.6 Assess Bioprocess Safety Risks and Assign Bioprocess Safety Hazard Level; 3.1.7 Identify Bioprocess Controls and Risk Management Options; 3.1.8 Document Bioprocess Safety Hazard Risks and Management Decisions; 3.1.9 Communicate and Train on Bioprocess Safety Hazards; 3.1.10 Investigate & Learn from Bioprocess Incidents; 3.1.11 Review, Audit, Manage Change, and Improve Hazard Management Practices and Program; 3.2 Existing Management Systems; 3.2.1 Product Stewardship for Bioproducts 3.3 Establishing a Bioprocess Safety Management System3.3.1 Select a Management System Model Based Upon Your Needs; 3.3.2 Identifying the Elements that Apply to Your Operations; 3.3.3 Establish a Review and Approval Cycle for the Documents; 3.3.4 Rolling Out the Management System to the Users; 3.4 Biosafety Training for the Workforce; 3.5 Investigating Incidents; 3.5.1 A Generic Procedure for Initial Biohazard Incident Response; 3.6 Managing Change; 3.7 Reviewing and Auditing for Continuous Improvement; 3.8 Applying Behavior-Based Safety to Bioprocesses; 4 IDENTIFYING BIOPROCESS HAZARDS 4.1 Key Considerations for Assessing Risk to Manage Bioprocess Safety |
| Record Nr. | UNINA-9910840626503321 |
| Hoboken, N.J., : Wiley-AIChE, 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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