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Emerging Issues in Biopharmaceutical Manufacturing in 2021

Research and Markets

Dublin, Nov. 19, 2021 (GLOBE NEWSWIRE) -- The "18th Annual Report and Survey on Biopharmaceutical Manufacturing Capacity and Production" report has been added to ResearchAndMarkets.com's offering.

The 2021 Report and Survey of Biopharmaceutical Manufacturing Capacity and Production is the most recent study of biotherapeutic developers and contract manufacturing organizations' current and projected future capacity and production.

In-depth analysis and summary of the key survey findings, trends and implications for industry-wide biomanufacturing capacity and biotherapeutic production. Comparison of production by biotherapeutic developers and contract manufacturing organizations. Current and future potential industry bottlenecks.

Trend analysis in this 18th in a series of annual biopharmaceutical manufacturing industry evaluations. This edition includes the joint industry expertise from the publisher, and many industry consultants and experts.

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It also features an updated special supplement on Covid-19 Crisis-Impact on Bioprocessing, and Suppliers.

Key Topics Covered:

FUTURE OF BIOPROCESSING: EXPERTS' PERSPECTIVE

  • COVID-19 Impact on Bioprocessing: From the Beginning of the Pandemic through Recovery.

  • FDA Biopharmaceutical Approvals in 2020

  • Scaling Up Gene Therapy Manufacturing with Single-Use Technology

  • Manufacturing Facility Change Needs in a New Era of Therapies

  • Process Intensification in the CMO World

  • Cell & Gene Therapy CMO Landscape Including Industry Consolidation via M&A

  • China-based Bioprocessing CMOs: Status and Prospects

EMERGING ISSUES IN BIOPHARMACEUTICAL MANUFACTURING

  • Industry Trends in 2021

  • Budget Issues in 2021

  • Operational Changes

  • New Bioprocessing Products Development Opportunities in 2021

  • Cost-Cutting Actions & Development Timelines

  • Average Cost per Gram Recombinant Protein

  • Assay Development

  • Selecting Bioreactors in New Facilities

  • Selecting and Purchasing Commercial-Scale Bioreactors

CAPACITY UTILIZATION

  • Capacity Utilization Trends

  • Capacity Utilization: Biomanufacturers vs. CMOs

  • Capacity Utilization: U.S. vs. Western European Manufacturers

  • Respondents' Current Total Production Capacity

  • Discussion: Capacity Trends

  • Range of Titers with mAb Production

CURRENT AND FUTURE CAPACITY CONSTRAINTS AND QUALITY FACTORS

  • Current Capacity Constraints

  • Expected Capacity Constraints

  • Factors Impacting Future Production Capacity

  • Key Areas to Address to Avoid Future Capacity Constraints

  • Batch Failure Frequency in Biopharmaceutical Manufacturing

  • Primary Cause of Batch Failures, Percentages of Failures

  • Quality Problems in Biomanufacturing Attributed to Vendors

  • Discussion: Industry Trends

FUTURE CAPACITY EXPANSIONS

  • Planned Future Capacity Expansions

  • Planned Future Capacity Expansions, 2009-2026

  • Planned Future Capacity Expansions by 2026: CMOs vs. Biotherapeutic Developers

  • Planned Five-Year Capacity Expansion: U.S. vs. Western European Manufacturers

  • Planned Future Capacity Expansions

CHAPTER 7: OUTSOURCING TRENDS IN BIOPHARMACEUTICAL MANUFACTURING

  • Current Outsourcing by Production System

  • Future Outsourcing Biotherapeutic Developers' Outsourcing,

  • Outsourced Activities in Biopharmaceutical Manufacturing

  • Critical Outsourcing Issues Selecting a CMO: (2018 data)

  • CMOs' Problems with Their Clients

  • Country Selections for International Outsourcing (Offshoring) of Biomanufacturing

  • Offshoring Trends

  • Discussion of Outsourcing and Offshoring

DISPOSABLES AND SINGLE-USE SYSTEMS IN BIOPHARMACEUTICAL MANUFACTURING

  • Use of Disposables and Single-Use Systems

  • Leachables and Extractables

  • Reasons for Increasing Use of Disposables & Single-Use Systems

  • Factors That May Restrict Use of Disposables

  • Suppliers' Expectations for Standards Setting Bodies

  • Single-Use Adoption Issues

  • Need for Single-use Sensors, and Bioreactor Attributes

  • Satisfaction with Single-Use Device Vendors

  • Single-Use Operations and Trends

  • Discussion: Single-use Bioprocessing

DOWNSTREAM PURIFICATION

  • Impact of Downstream Processing on Capacity

  • Specific Purification Step Constraints

  • Downstream Purification Issues

  • mAb Purification Capacity Estimates

  • New Downstream Processing Technologies

  • Improvements to Downstream Operations

  • Discussion: Industry Trends Upstream Expression Titer Trends and Impact on Downstream Operations

HIRING, EMPLOYMENT GROWTH, AND TRAINING IN BIOPHARMACEUTICAL MANUFACTURING

  • Hiring Trends

  • Hiring in 2026: 5-year Trends

  • Hiring Challenges Today

  • Training in Biopharmaceutical Manufacturing

  • Discussion: Training Industry Trends

NEW METHODS: CONTINUOUS AND PROCESS INTENSIFICATION, CELL AND GENE THERAPIES

  • Perfusion Operations and Continuous Bioprocessing Operational Issues

  • Perfusion Operations and Continuous Bioprocessing Trends

  • Discussion: Continuous Bioprocessing and Perfusion Trends

  • Cell and Gene Therapy Platforms

SUPPLIERS TO BIOPHARMACEUTICAL MANUFACTURING AND LIFE SCIENCES

  • Demographics Areas of Involvement

  • Growth Rate of Sales by Suppliers

  • Discussion: Vendor and Industry Growth

  • Budget Issues and Problems Faced by Industry Suppliers

  • Cost Cutting Actions by Vendors

  • Problems Clients Have with Their Vendors

  • Vendor Expansion Plans

  • New Technology Areas in Development by Vendors

  • Sales Staff Training

  • Biopharma Vendors' Financial Outlook for 2021

  • CMO Pricing Changes for Biopharmaceutical Services

  • Discussion: Biopharma Suppliers Bioprocessing Vendors Will See Continued Market Growth

For more information about this report visit https://www.researchandmarkets.com/r/ktmjp2

About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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