Flow cytometry is used in nearly every single cell therapy process, for process characterization, montioring process parameters, and release of the final product.
The assay is inherently variable due to the variety of instruments, the antibody clones, reference setting protocols, assay protocols, and the lack of controls that can be implemented.
Lonza Cell and Gene Therapy (CGT) operates under a site agnostic model, in order support the demand and the variety of cell therapy products of our clients. This model requires each site to operate similarly like every other site within the network, and as such, a flow assay should perform similiarity, for routine and validation, from site to site.
Lonza has implemented the BD FACSLyric™ Flow Cytometer in CGT Quality Control (QC) laboratories. The capability of the BD FACSLyric™ Flow Cytometer to set specific tube settings as part of the template, ensures consistent mean fluorescent intensity of the panel for the same sample from instrument to instrument. This allows the flow assay to demonstrate high precision even when executing the same assay at different QC labs.
Validation of flow assays for GMP execution is a challenging process, especially when evaluting the live/dead populations. Lonza has examined two common cell killing methods, ethanol and fixation buffers, that are suitable for flow assay live/dead determination. Depending on the type of sample validated, each killing method offers pros and cons.
The analytical direction at Lonza continues to strive for consistency and robustess to support our global manufacturing sites.
Fill out the form and watch the on-demand webinar, “Validating Flow Cytometry Assays for Cell Therapy.”
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