Cell and cell-based therapies are a novel and growing class of transformative therapies designed to address gaps in traditional treatment strategies. Regulatory approval for cell or cell-based products requires therapeutic developers to have a set of analytical tests to demonstrate safety, purity and potency. These tests must be validated and performed under current good manufacturing practice (cGMP) conditions.
In this whitepaper by BioBridge Global, Scott Jones, VP of Scientific Affairs at BioBridge Global, and Anthony Trinh, Senior Manager, Analytical Development Cell Therapy Reference Laboratory at QualTex Laboratories, go through 5 testing strategies that QualTex Laboratories use to help customers in the cell and cell-based therapy industry.
These strategies include:
- Assay development process
- Criticality of potency assays
- Qualitative versus quantitative assays
- Use of blood screening safety assays
- Phase appropriate validations
