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Global Biopharmaceutical Manufacturing Capacity and Production Report 2022: In-depth Analysis of Capacity, Production Trends, Benchmarks, and Much More

DUBLIN, Sept. 13, 2022 /PRNewswire/ — The “19th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production” report has been added to  ResearchAndMarkets.com’s offering.

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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/uyble4

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