Key Considerations for Scale Up Cell & Gene Therapy

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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.

The experts at Pharmatech Associates can help you scale up your cell and/or gene therapy company. Contact us today!


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