Dublin, Sept. 07, 2022 (GLOBE NEWSWIRE) -- The "19th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production" report has been added to ResearchAndMarkets.com's offering.
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
- Production trends and Outsourcing trends
- International offshoring through 2027
- Range of titers, growth
- Disposables: Spending growth; downstream uses; L&E's; reasons for increasing/ restricting; budget increases; vendor satisfaction
- Batch failure rates & trends
- Selecting a CMO - Problems & solutions
- Quality management & PAT implementation
- Hiring and employment growth
- Supplier growth rates, and much more
- 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 6: FUTURE CAPACITY EXPANSIONS
6-1 Planned Future Capacity Expansions
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
For more information about this report visit https://www.researchandmarkets.com/r/dzprug
