Need for Scalable, Reproducible, and Cost-Effective Manufacturing Processes Driving Growth Opportunities
The publisher's research service discusses the cell and gene therapy (CGT) market and highlights some key roadblocks in viral vector manufacturing. While many CGT candidates exist in the pipeline, there is a huge capacity deficit that the industry is collaboratively trying to address. Scalability, costs, reproducibility, and overall process efficiency are some of the main pain points at each step of the viral vector manufacturing process. Many industry stakeholders are capitalizing on innovative, sustainable business models and capacity expansion investments to address shortage issues. Biotechnology companies, such as Merck, Novartis, and Pfizer, and key contract development and manufacturing organizations, such as Thermo Fisher Scientific, Catalent, and FUJIFILM Diosynth Technologies, are investing in new capacities, expanding capacities, and developing innovative technologies to stay ahead in the CGT market.
The research covers emerging technologies and trends, challenges, and opportunities across the manufacturing workflow, from upstream (viral vector production) to downstream (viral vector purification). Key developments in upstream processes for viral vector production include advanced transfection agents, novel plasmids, suspension-adapted cell culture, and stable producer cell lines. The research also discusses the general industry shift toward adopting automation, digitization, and advanced analytical processes, including on-line and in-line analytics and robust real-time analytics, to highlight the importance of analytical tools throughout the value chain. Smart technologies, such as automation and digital tools, and the adoption of artificial intelligence and big data support progress in process control and optimization while improving overall efficiencies and safety.
The CGT industry works through orchestrated collaborations to develop reference standards and build process analytical technologies (PAT) to optimize manufacturing further. The research presents a bird’s eye view of key stakeholders and their innovative platforms and a snapshot of the collaborative ecosystem to understand the CGT industry’s dynamic and fast-paced nature.
Table of Contents
1.0 Strategic Imperatives
1.1 Why Is It Increasingly Difficult to Grow?
1.2 The Strategic Imperative 8™
1.3 The Impact of the Top Three Strategic Imperatives on Viral Vector Manufacturing for Cell and Gene Therapies
1.4 Growth Opportunities Fuel the Growth Pipeline Engine™
2.0 Growth Opportunity Analysis
2.1 Research Context
2.2 Research Scope - Key Questions Addressed
2.3 Research Methodology
2.4 Manufacturing is the Most Critical Bottleneck in Realizing CGT Potential
2.5 Advanced Manufacturing and Digital Technologies Integration Improve Efficiencies
2.6 Viral Vector Manufacturing - A Dynamically Evolving Road Ahead
2.7 Key Findings
3.0 Technology Trends Influencing Viral Vector Manufacturing
3.1 Macro to Micro Visions and Implications
3.2 Advanced Therapeutics Manufacturing is Complex Compared to Monoclonal Antibodies and Recombinant Proteins Manufacturing
3.3 Key Challenges in CGT Biomanufacturing
3.4 Need to Shift from the Gold Standard to Address Manufacturing Bottlenecks
3.5 Emerging Technology Trends in CGT Manufacturing
3.6 Shifting Technology Trends Across the CGT Manufacturing Workflow
3.7 Developments and Priorities for Viral Vector Manufacturing
3.8 How to Stay Ahead of the Curve in CGT Manufacturing
3.9 Glimpse of the Innovation Universe in CGT Manufacturing
4.0 Upstream Bioprocesses - Bottlenecks and Developments
4.1 Upstream Processing - Challenges and Developments
4.2 Trends in Host Cell Line Development
4.3 Transfection Efficiencies Improve with Advanced Transfection Agents and the Development of Stable Producer Cell Lines
4.4 Host Cell Line Development and Stable Packaging Cell Lines
4.5 Plasmids and Advanced Transfection
4.6 Industrial-scale Bioreactors for CGT
4.7 Bioreactors and Integrated Equipment for Upstream Processing
4.8 Cell Expansion and Microfluidics-based Process Improvement Platforms
4.9 Key Integrated Manufacturing Platform Developers
4.10 Emerging Opportunities for Upstream Processes
5.0 Downstream Bioprocesses - Bottlenecks and Developments
5.1 Downstream Processing of Viral Vectors
5.2 Downstream Processing - Challenges and Developments
5.3 Key Participants in Downstream Processing Development
6.0 Analytics for Viral Vector Manufacturing Processes and Products
6.1 Developing Robust Analytical Tools for Product Safety and Characterization
6.2 Challenges and Developments in Viral Vector Analytics
6.3 Current Standards for Viral Vector Analysis
6.4 Next-Generation Tools for Viral Vector Analysis
6.5 Emerging Opportunities - Analytics and Assays
6.6 Key Developers of Viral Vector Analytics and Assays
7.0 Technology Enablers Bolstering Viral Vector Manufacturing
7.1 Data Science Enabling CGT Manufacturing
7.2 Digital Technologies Increasingly and Seamlessly Adopted into the CGT Workflow
7.3 Digitization and Big Data in CGT Manufacturing
8.0 Industry Initiatives and the Stakeholder Ecosystem
8.1 Stakeholders Need a Multifaceted Approach to Gain Technology Leadership in CGT Manufacturing
8.2 Orchestrated Collaborations between Stakeholders are Critical
8.3 Key Innovators in CGT Manufacturing
8.4 Evolving Landscape with Increasing Industry Partnerships and Investments
8.5 Advancing CGT Products by Partnering with CDMOs
8.6 Latest Capacity Expansion Plans for Viral Vector Production
8.7 Strategic Collaborations Bolster Product Developments and Manufacturing Support
8.8 Multiple Acquisitions Increase Manufacturing Capacity and Strengthen Capabilities
8.9 Acquiring Technology Start-ups to Build Value and Solidify Market Position
8.10 Accelerate Innovations through Consortia and Public-Private Partnerships
8.11 Collaborations and Licensing Strengthen Technology Offerings
9.0 Funding Trends Supporting Viral Vector Manufacturing
9.1 Significant Venture Capital and Private Equity Funding Boost Innovations in Viral Vector Manufacturing
9.2 Robust Federal Funding and Investments from Large Biotechnology Companies Support the CGT Manufacturing Market
10.0 Growth Opportunity Universe
10.1 Growth Opportunity 1: Plug-and-Play Platform Technologies Enhance the Manufacturing Workflow
10.2 Growth Opportunity 2: Adopting SUTs to Improve Flexibility and Reduce Cost
10.3 Growth Opportunity 3: Close to Real-time Data Analytics Drive Efficiencies and Support PAT Integration
10.4 Growth Opportunity 4: Replicate Intensified and Continuous Manufacturing Like in Traditional Biotherapeutics
11.0 Appendix
11.1 Upstream Cell Culture for LV Production
11.2 Key Investments in Capacity Development and Expansion
11.3 Acronyms Used
12.0 Next Steps
12.1 Your Next Steps
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