Cell & Gene Therapy
ALCOA+ applies equally to a small molecule tablet and an autologous CAR-T product. But the complexity of applying it is not equal. CGT manufacturers deal with novel and variable assays, patient-specific chain-of-custody data, manufacturing platforms with no established validation playbooks, and the expectation of BLA-quality data from early in clinical development. This pillar covers what makes CGT data integrity structurally different and what mature programs actually look like.
Articles in this pillar
Cell & Gene Therapy: Why Data Integrity Is Structurally Different
How the scientific and regulatory characteristics of CGT create data integrity challenges that don't exist in conventional drug manufacturing, and what to do about them.
Data Integrity in Gene Therapy: What FDA Really Expects
A practical breakdown of FDA's data integrity expectations for gene therapy manufacturers, beyond the checklist, into the actual inspection findings.