Regulatory challenges and considerations for the clinical application of CAR T cell therapy

Bachmeier, Christina A.; Kurian, Tony; Davila, Marco L.

doi:10.1080/14712598.2021.1887130

Cited by 5 publications

(1 citation statement)

References 13 publications

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“…Additionally, regulatory agencies require cell therapy manufacturers to set acceptability criteria related to cell concentration and viability, which are then used for dosing purposes (Guidance for Human Somatic Cell Therapy and Gene Therapy, 1998). For these treatments, getting the dose to the patient is typically time-sensitive and it is crucial that the concentration and viability of the cells being infused is sufficient (Tyagarajan et al, 2020;Bachmeier et al, 2021). All of these applications necessitate accurate measurements, and standards to ensure that cell counting methods being utilized are accurate for designated control points in the workflow.…”

Section: Metricmentioning

confidence: 99%

Assessing the suitability of cell counting methods during different stages of a cell processing workflow using an ISO 20391-2 guided study design and analysis

Richards

Sarkar

Kandell

et al. 2023

Front. Bioeng. Biotechnol.

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Cell counting is a fundamental measurement for determining viable cell numbers in biomanufacturing processes. The properties of different cell types and the range of intended uses for cell counts within a biomanufacturing process can lead to challenges in identifying suitable counting methods for each potential application. This is further amplified by user subjectivity in identifying the cells of interest and further identifying viable cells. Replacement of traditionally used manual counting methods with automated systems has alleviated some of these issues. However, a single cell type can exhibit different physical properties at various stages of cell processing which is further compounded by process impurities such as cell debris or magnetic beads. These factors make it challenging to develop a robust cell counting method that offers a high level of confidence in the results. Several initiatives from standards development organizations have attempted to address this critical need for standardization in cell counting. This study utilizes flow-based and image-based methods for the quantitative measurement of cell concentration and viability in the absence of a reference material, based on the tools and guidance provided by the International of Standards (ISO) and the US National Institute of Standards and Technology (NIST). Primary cells were examined at different stages of cell processing in a cell therapy workflow. Results from this study define a systematic approach that enables the identification of counting methods and parameters that are best suited for specific cell types and workflows to ensure accuracy and consistency. Cell counting is a foundational method used extensively along various steps of cell and gene therapy. The standard used in this study may be applied to other cell and gene therapy processes to enable accurate measurement of parameters required to guide critical decisions throughout the development and production process. Using a framework that confirms the suitability of the cell counting method used can minimize variability in the process and final product.

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Section: Metricmentioning

confidence: 99%