Enhancing Cell Therapy Consistency and Safety

Published on 11 March 2026

Enhancing Cell Therapy Consistency and Safety: Recombinant Human Albumin as a Defined Alternative to Plasma-Derived Albumin in Wash and Cryopreservation Workflows

This poster evaluates recombinant human serum albumin (rHSA, Optibumin® 25) as a structurally defined alternative to plasma-derived human serum albumin (pHSA) in T cell wash and cryopreservation workflows. Analytical characterization (SEC and Cys34 redox) demonstrates reduced aggregate burden and structural heterogeneity, with functional validation in T cell and MSC cryopreservation, including reduced-DMSO conditions.

Equivalent T Cell Retention and Viability

Primary human T cells washed in PBS or Plasma-Lyte ± albumin retained ~65% viable cells with albumin vs 15–25% without. Viability change remained <5% across albumin conditions.

Recombinant HSA performed comparably to plasma-derived HSA.

Enhanced Post-Thaw Expansion Under Reduced DMSO

In CryoStor CS10 and CS5, 10% recombinant albumin supported ~2× higher post-thaw T cell expansion vs no-albumin controls (p < 0.001).

CS5 + 10% rHSA achieved expansion equivalent to CS10 at ~40% lower final DMSO concentration.

Maintained Viability and Reduced Apoptosis at Reduced DMSO

UC-MSCs cryopreserved in CS5 and CS2 (2.5% and 1% final DMSO) demonstrated restored viability (~85%) and reduced apoptosis (~50% reduction vs no-albumin control) when recombinant albumin was included.

Performance was comparable to CS10 reference conditions.

Reduced Aggregate Burden and Defined Redox Profile

High-resolution 3 µm SEC analysis across 15 recombinant HSA lots and 8 plasma-derived HSA lots demonstrated <0.5% aggregates in rHSA compared to ~7.5% in pHSA, with 10× lower lot-to-lot variability.

RP-HPLC analysis of Cys34 redox state across 10 recombinant and 9 plasma-derived lots showed ~99% reduced Cys34 in rHSA vs ~60% in pHSA.

This supports reduced structural heterogeneity in recombinant albumin.

Together, these data demonstrate that recombinant human serum albumin provides a structurally defined, functionally validated alternative to plasma-derived HSA for T cell and MSC processing and cryopreservation workflows.

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