Analytical testing strategies for gene therapy: GMP release testing, stability testing and comparability assessments
04 May 2026
Gene Therapy Manufacturing
- What are the key challenges associated with DS/DP release testing?
- How does testing differ when performed at a CDMO versus a CRO?
- What are the main differences and considerations when testing at the DS stage compared to the DP stage?
- What challenges arise when moving or adding manufacturing and/or analytical testing sites?
- What are the common challenges encountered during analytical validation?
