Cell & Gene Therapy Resources

Seven criteria for evaluating primary cell vendors: yield specifications, donor characterization depth, HLA methodology, recallability, RUO-to-cGMP continuity, isolation method, and documentation standards.

Use-case decision table covering CAR-T manufacturing, PBMC isolation, process development, longitudinal studies, and batch comparison work — with handling notes for each format.

T cell differentiation from naive to TEMRA, markers and CAR-T relevance at each stage, negative vs positive isolation comparison, and peripheral blood vs cord blood T cell differences.

How each isolation method works, its impact on receptor state, activation markers, expansion, and transduction efficiency — and why the difference matters most for CAR-T manufacturing.

When HLA typing is required, what 6-gene NGS allele-level resolution means vs serotyping, G-code reporting format, and why HLA-homozygous donors are sought for allogeneic programs.

What CAR-T programs need from starting material, autologous vs allogeneic differences, a full specifications table, and what to verify in a supplier before committing to a cGMP path.

What recallability actually means operationally — stable ID, active consent, schedulable re-collection — why it matters for longitudinal work and allogeneic programs, and the questions to ask any supplier before assuming their pool qualifies.

What changes at each IND phase, why switching suppliers mid-development costs programs months of revalidation, phase-appropriate sourcing strategy, and what to ask any supplier about their cGMP path before Phase I.

The complete documentation checklist — CoA components, 21 CFR 1271 infectious disease screening panel, chain of custody, donor characterization data, and what IND submissions require from cGMP starting material.