Risk-Based Identity Testing of Raw Materials in Gene Therapy Manufacturing
Ensuring raw material identity is essential for compliance, scalability, and cost control in gene therapy manufacturing. This resource outlines how a risk-based approach at the PPQ stage streamlines testing and supports commercial readiness.
Inside you’ll find:
- Key regulatory requirements (FDA, ICH)
- Risk-based decision tree for testing strategies
- Case examples with cost-saving outcomes
- Additional methods like amino acid analysis and CoA verification
Ensuring raw material identity is essential for compliance, scalability, and cost control in gene therapy manufacturing. This resource outlines how a risk-based approach at the PPQ stage streamlines testing and supports commercial readiness.
Inside you’ll find:
- Key regulatory requirements (FDA, ICH)
- Risk-based decision tree for testing strategies
- Case examples with cost-saving outcomes
- Additional methods like amino acid analysis and CoA verification
Ensuring raw material identity is essential for compliance, scalability, and cost control in gene therapy manufacturing. This resource outlines how a risk-based approach at the PPQ stage streamlines testing and supports commercial readiness.
Inside you’ll find:
- Key regulatory requirements (FDA, ICH)
- Risk-based decision tree for testing strategies
- Case examples with cost-saving outcomes
- Additional methods like amino acid analysis and CoA verification