Optimization-by-Design™ - A Critical Factor in Successful Viral Vector Scale Up & Scale Down
In gene therapy manufacturing, scale is not something to be solved at the end of development. It should influence the strategy from the start. One of the first questions teams need to answer is where the process ultimately needs to land and how to build a practical path to reach that point. When scale is considered early and guided by process history, teams can make better decisions, reduce unnecessary development time, and lay a stronger foundation for later-stage manufacturing.
What is the Utility of Scale Down?
A well-designed scale-down model plays a crucial role in that process. It supports process design, enables optimization, and helps teams build the process understanding necessary for control at GMP scale. When combined with a modular platform approach like Andelyn’s Curator® Platform, scale-down work can be used to evaluate critical process parameters, improve productivity, and tailor development to the needs of a specific program.
Manufacturing Strategy Considerations
This webinar examines how scale-down models support manufacturing strategies from early development to commercial readiness. Topics include the usefulness of Design of Experiments (DoE), the connection between scale-down and scale-up, and the program-specific factors that determine whether a therapy is better suited for scale-out or suspension-based scale-up. The discussion also emphasizes a key reality of gene therapy manufacturing: process design, productivity, and quality are closely linked, and careful process characterization is vital for long-term control, consistency, and regulatory compliance.
Experience Andelyn’s Optimization-by-Design Framework
If you're interested in learning more about our design framework and platform process, please contact us.
In gene therapy manufacturing, scale is not something to be solved at the end of development. It should influence the strategy from the start. One of the first questions teams need to answer is where the process ultimately needs to land and how to build a practical path to reach that point. When scale is considered early and guided by process history, teams can make better decisions, reduce unnecessary development time, and lay a stronger foundation for later-stage manufacturing.
What is the Utility of Scale Down?
A well-designed scale-down model plays a crucial role in that process. It supports process design, enables optimization, and helps teams build the process understanding necessary for control at GMP scale. When combined with a modular platform approach like Andelyn’s Curator® Platform, scale-down work can be used to evaluate critical process parameters, improve productivity, and tailor development to the needs of a specific program.
Manufacturing Strategy Considerations
This webinar examines how scale-down models support manufacturing strategies from early development to commercial readiness. Topics include the usefulness of Design of Experiments (DoE), the connection between scale-down and scale-up, and the program-specific factors that determine whether a therapy is better suited for scale-out or suspension-based scale-up. The discussion also emphasizes a key reality of gene therapy manufacturing: process design, productivity, and quality are closely linked, and careful process characterization is vital for long-term control, consistency, and regulatory compliance.
Experience Andelyn’s Optimization-by-Design Framework
If you're interested in learning more about our design framework and platform process, please contact us.
In gene therapy manufacturing, scale is not something to be solved at the end of development. It should influence the strategy from the start. One of the first questions teams need to answer is where the process ultimately needs to land and how to build a practical path to reach that point. When scale is considered early and guided by process history, teams can make better decisions, reduce unnecessary development time, and lay a stronger foundation for later-stage manufacturing.
What is the Utility of Scale Down?
A well-designed scale-down model plays a crucial role in that process. It supports process design, enables optimization, and helps teams build the process understanding necessary for control at GMP scale. When combined with a modular platform approach like Andelyn’s Curator® Platform, scale-down work can be used to evaluate critical process parameters, improve productivity, and tailor development to the needs of a specific program.
Manufacturing Strategy Considerations
This webinar examines how scale-down models support manufacturing strategies from early development to commercial readiness. Topics include the usefulness of Design of Experiments (DoE), the connection between scale-down and scale-up, and the program-specific factors that determine whether a therapy is better suited for scale-out or suspension-based scale-up. The discussion also emphasizes a key reality of gene therapy manufacturing: process design, productivity, and quality are closely linked, and careful process characterization is vital for long-term control, consistency, and regulatory compliance.
Experience Andelyn’s Optimization-by-Design Framework
If you're interested in learning more about our design framework and platform process, please contact us.