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GENE AND CELL THERAPY:
Planning for Manufacturing Success Early
Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this whitepaper, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on years of experience. You will learn about:
- How to navigate the evolving landscape of gene and cell therapy.
- The importance of establishing and preparing your Target Product Profile early in development.
- Commonly overlooked plasmid DNA construct considerations.
Expanded Focus on CMC
Gene and cell therapy developers are contending with the implications of the evolving need for quality while trying to rapidly progress programs.
Establishing a Baseline
A well-organized TPP can provide definition to regulators. Drug developers can support the development of a TPP by reviewing six key areas.
Construct Design Elements
Early consideration of four key pDNA construct design areas will reduce delays, shorten approval time, and realize cost saving.
Critical Quality Attributes
The FDA defines a CQA as a physical, chemical biological, or microbiological property. In the context of cell & gene therapy, there are multiple factors to consider.
Contract & Licensing Considerations
Contract negotiation and licensing/royalty terms have strong implications to the future success of organizations early in their development.
The Path Forward
The gene and cell therapy industry continues to grow rapidly; following various key success items will ensure future stability for your organization and patients.