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Key Considerations for Scale Up Cell & Gene Therapy

Autologous vs Allogenic Cell Sources

Autologous Cells

Cost: Patient-derived cells are more expensive to obtain, resulting in high cost to patient.

Logistics: Complex logistical requirements impact timing to the patient.

Cell Condition: Patient-derived cells can be compromised and unhealthy.

Eligibility: Donor eligibility is not required but product labeling requirements apply per CFR Part 1271.90

Scaling: Highly manual and open nature of processing requires aseptic processing operations. Need for scale-out rather than scale up.

Allogenic Cells

Cost: Donor derived sales are readily available.

Logistics: Similar to traditional biologics. Cell stocks are readily available.

Cell Condition: Donor derived cells come from healthy patients.

Eligibility: Donor and screening testing required per 21 CFR part 1271.

Scaling: Similar to scaling up mAb production in that volume can increase easily. Only challenge is when DNA is introduced.

You may be interested in the following article:

A Comparative Framework Between New Product and Legacy Product Process Validation

This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.