Global Biopharmaceutical Manufacturing Capacity and Production Report and Survey 2022: Compare 140+ Biomanufacturers vs CMOs; U.S. vs. European & Global Biomanufacturing
This report's ~500 pages of data-rich analysis will help improve your decision-making in biomanufacturing operations, with an in-depth analysis of capacity, production trends, benchmarks, and much more.
Coverage
In-depth analysis of key data, capacity, production trends, and benchmarks
Budget trends and impact of the current economic environment
Downstream purification problems and issues
Current and projected industry bottlenecks
Capacity utilization and current production levels
Capacity bottlenecks - what's being done to resolve
Compare 140+ Biomanufacturers vs CMOs; U.S. vs. European & Global Biomanufacturing
Key Topics Covered:
CHAPTER 0: DEMOGRAPHICS 0-1 Respondents' Area of Involvement 0-2 Respondents' Qualifications 0-3 Facility Locations 0-4 Areas of Biopharmaceutical Manufacturing Operations 0-5 Production Operations, Phase of Development 0-6 Employees at Facility 0-7 Batches Run at Facility per Year 0-8 Single-Use Bioreactor Capacity in Use at Site 0-9 Stainless Steel Bioreactor Capacity in Use at Site
CHAPTER 1: INTRODUCTION AND DISCUSSION 1-1 Sector/Market Overview 1-2 Biopharmaceutical Industry Status and Market Trends 1-3 Pharma Industry is Shifting to Biopharmaceuticals 1-4 Global Biopharmaceutical Market Trends 1-5 Biopharmaceutical Markets by Product Class 1-6 Animal Derived Products and Biopharmaceuticals 1-7 Future Trends in the Biopharmaceutical Industry
CHAPTER 2: FUTURE OF BIOPROCESSING: EXPERTS' PERSPECTIVE 2-1 Case Study: Expanding Production Capacity for High Producing mAb Processes 2-2 Case Study: A Raw Material Issue Derails PPQ and 2-3 Case Study: Overcoming Materials Supply Challenges 2-4 Case Study: Selecting the Right Facility Design and Technology to Support AAV Production at Scale 2-5 Case Study: Tech Options to Improve Low-Producing Biotherapeutic Processes. 2-6 Case Study: Bridging the Cell and Gene Therapy Technology Gap 2-7 Case Study: Implementation of a Continuous Technology Strategy to 2-8 Case Study: Build or Buy Decision for Cell and Gene Therapy Companies 2-9 Case Study: Scale-Up Challenges of E. Coli Protein Production Process 2-10 Case Study: Increased Bioburden Excursions in an Aging Facility 2-11 Case Study: Navigating and Making Better 2-12 Getting to Yes: How Major Changes at Phase Can Make an Unapprovable Product Approvable 2-13 Lower Operational Cost by Reducing
CHAPTER 3: EMERGING TECHNOLOGIES 3-1 Bioprocessing Innovations Needed in 2022 3-2 Operational Changes in 2022 3-3 Budget Issues in 2022 3-4 New Bioprocessing Products Development Opportunities in 2022 3-5 Cost-Cutting Actions & Development Timelines 3-6 Average Cost per Gram Recombinant Protein 3-7 Assay Development 3-8 Selecting and Purchasing Commercial-Scale Bioreactors 3-9 Discussion: Industry Trends and Issues
CHAPTER 4: CAPACITY UTILIZATION. 4-1 Capacity Utilization Trends 4-2 Capacity Utilization: Biomanufacturers vs. CMOs 4-3 Capacity Utilization: U.S. vs. Western European Manufacturers 4-4 Respondents' Current Total Production Capacity 4-5 Range of Titers with mAb Production 4-6 Discussion: Capacity and Industry Trends
CHAPTER 5: CURRENT AND FUTURE CAPACITY CONSTRAINTS AND QUALITY FACTORS 5-1 Current Capacity Constraints 5-2 Expected Capacity Constraints 5-3 Factors Impacting Future Production Capacity 5-4 Key Areas to Address to Avoid Future Capacity Constraints 5-5 Batch Failures in Biopharmaceutical Manufacturing 5-6 Automation Implementation 5-7 Quality Problems in Biomanufacturing Attributed to Vendors 5-8 Discussion: Industry Trends
CHAPTER 7: OUTSOURCING TRENDS IN BIOPHARMACEUTICAL MANUFACTURING 7-1 Current Outsourcing by Production System 2006-2022 7-2 Future Outsourcing 7-3 Outsourced Activities in Biopharmaceutical Manufacturing 7-4 Critical Outsourcing Issues 7-5 CMOs' Problems with Their Clients 7-6 Country Selections for International Outsourcing (Offshoring) of Biomanufacturing 7-7 Offshoring Trends 7-8 Discussion of Outsourcing and Offshoring
CHAPTER 8: DISPOSABLES AND SINGLE-USE SYSTEMS IN BIOPHARMACEUTICAL MANUFACTURING 8-1 Use of Disposables and Single-Use Systems 8-2 Leachables and Extractables 8-3 Reasons for Increasing Use of Disposables & Single-Use Systems 8-4 Factors That May Restrict Use of Disposables 8-5 Single-Use Adoption Issues 8-6 Need for Single-use Sensors, and Bioreactor Attributes 8-7 Satisfaction with Single-Use Device Vendors 8-8 Single-Use Operations and Trends 8-9 Discussion: Single-use Bioprocessing
CHAPTER 9: DOWNSTREAM PURIFICATION 9-1 Impact of Downstream Processing on Capacity 9-2 Specific Purification Step Constraints 9-3 Downstream Purification Issues 9-4 mAb Purification Capacity Estimates 9-5 New Downstream Processing Technologies 9-6 Improvements to Downstream Operations 9-7 Discussion Industry Trends
CHAPTER 10: HIRING, EMPLOYMENT GROWTH, AND TRAINING IN BIOPHARMACEUTICAL MANUFACTURING 10-1 Hiring Trends 10-2 Hiring in 2027: 5-year Trends 10-3 Hiring Challenges Today 10-4 Training in Biopharmaceutical Manufacturing 10-5 Discussion: Training Industry Trends
CHAPTER 11: NEW METHODS: CONTINUOUS AND PROCESS INTENSIFICATION, CELL AND GENE THERAPIES 11-1 Continuous Bioprocessing and Process Intensification 11-2 Perfusion Operations and Continuous Bioprocessing Operational Issues 11-3 Cell and Gene Therapy Platforms 11-4 Discussion
CHAPTER 12: SUPPLIERS TO BIOPHARMACEUTICAL MANUFACTURING AND LIFE SCIENCES 12-1 Demographics 12-2 Growth Rate of Sales by Suppliers 12-3 Budget Issues and Problems Faced by Industry Suppliers 12-4 Problems Clients Have with Their Vendors 12-5 Impacts of Covid-19 on Suppliers' Activities 12-6 New Technology Areas in Development by Vendors 12-7 Sales Staff Training 12-8 Biopharma Vendors' Financial Outlook for 2021 12-9 CMO Pricing Changes for Biopharmaceutical Services . 12-10 Discussion: Biopharma Suppliers Biopharma Suppliers in Emerging Regions
