Cell & Gene Therapy
Cell and gene therapies break many assumptions built into traditional GxP systems. This pillar covers why data integrity is structurally different for autologous, patient-specific products, chain of identity and custody, and BLA-level scrutiny.
4 articlesCell & Gene Therapy: Why Data Integrity Is Structurally Different
How the scientific and manufacturing characteristics of cell and gene therapy create data integrity challenges that conventional drug manufacturing never faces, and how to build a program that holds up at BLA inspection.
GMP for Cell and Gene Therapies: Chain of Identity, Chain of Custody, and ATMP Controls
How GMP works for autologous and viral-vector products, with chain of identity, chain of custody, single-batch release, and the EU ATMP framework explained for quality staff who run the operation.
Comparability and Potency Assays for Biologics and Cell & Gene Therapies
How to plan and execute an ICH Q5E comparability exercise and build a potency assay strategy for biologics and cell and gene therapies, including the matrix approach, acceptance criteria, and the inspection findings that recur.
Data Integrity in Gene Therapy: What FDA Really Expects
How FDA's data integrity expectations actually play out for advanced therapies, from inspection findings to the controls that pass and the procedures behind them.