Abstract:Background aims: Adoptive cellular therapy with immune effector cells (IECs) has shown promising efficacy against some neoplastic diseases as well as potential in immune regulation. Both inherent variability in starting material and variations in cell composition produced by the manufacturing process must be thoroughly evaluated with a validated method established to quantify viable lymphocyte subtypes. Currently, commercialized immunophenotyping methods determine cell viability with significant errors in thaw… Show more
“…Immune effector cells currently comprise cells that express broad cytotoxicity against tumours or targeted cytotoxicity against tumour‐associated antigens, as well as the cells that induce tolerance by suppressing inflammatory responses or enhancing immune recognition. Their identity, enumeration, and viability are critical information for initiating manipulation and releasing the products for infusion 49,50 …”
Section: Immune Effector Cellsmentioning
confidence: 99%
“…The standards clearly state that relevant and validated assay should be employed to evaluate cellular therapy products undergoing manipulation that alters the function of the target cell population, where multi‐colour flow cytometry is the technology of choice for cell surface marker detection, viability and enumeration. Accurate quantification of viable absolute numbers of cells is a prerequisite for several activities: standardization of input cellular material for CAR‐transduced T or NK cell manufacturing, cell selection, in‐process quality controls and dosing of IEC 50,51 …”
“…B cells [38,40,43,45,47,48,50,52] Anti-CD14 Monocytes [50] Anti-CD56/CD16 NK cells [38,40,48,50] cytotoxicity against tumour-associated antigens, as well as the cells that induce tolerance by suppressing inflammatory responses or enhancing immune recognition. Their identity, enumeration, and viability are critical information for initiating manipulation and releasing the products for infusion.…”
Section: Cell Line Referencesmentioning
confidence: 99%
“…Their identity, enumeration, and viability are critical information for initiating manipulation and releasing the products for infusion. 49,50 Despite rapid development, IECs therapy still faces several challenges such as manufacturing processes, logistic and coordination aspects and toxicity profiles. Therefore, the Immune Effector Cell Task Force was created the standards and accreditation program for IEC.…”
Cellular therapy nowadays includes various products from haematopoietic stem cells (HSC) collected from bone marrow, peripheral blood, and umbilical cord blood to more complex adoptive immune therapy for the treatment of malignant diseases, and gene therapy for inherited immune deficiencies. Broader utilization of cellular therapy
“…Immune effector cells currently comprise cells that express broad cytotoxicity against tumours or targeted cytotoxicity against tumour‐associated antigens, as well as the cells that induce tolerance by suppressing inflammatory responses or enhancing immune recognition. Their identity, enumeration, and viability are critical information for initiating manipulation and releasing the products for infusion 49,50 …”
Section: Immune Effector Cellsmentioning
confidence: 99%
“…The standards clearly state that relevant and validated assay should be employed to evaluate cellular therapy products undergoing manipulation that alters the function of the target cell population, where multi‐colour flow cytometry is the technology of choice for cell surface marker detection, viability and enumeration. Accurate quantification of viable absolute numbers of cells is a prerequisite for several activities: standardization of input cellular material for CAR‐transduced T or NK cell manufacturing, cell selection, in‐process quality controls and dosing of IEC 50,51 …”
“…B cells [38,40,43,45,47,48,50,52] Anti-CD14 Monocytes [50] Anti-CD56/CD16 NK cells [38,40,48,50] cytotoxicity against tumour-associated antigens, as well as the cells that induce tolerance by suppressing inflammatory responses or enhancing immune recognition. Their identity, enumeration, and viability are critical information for initiating manipulation and releasing the products for infusion.…”
Section: Cell Line Referencesmentioning
confidence: 99%
“…Their identity, enumeration, and viability are critical information for initiating manipulation and releasing the products for infusion. 49,50 Despite rapid development, IECs therapy still faces several challenges such as manufacturing processes, logistic and coordination aspects and toxicity profiles. Therefore, the Immune Effector Cell Task Force was created the standards and accreditation program for IEC.…”
Cellular therapy nowadays includes various products from haematopoietic stem cells (HSC) collected from bone marrow, peripheral blood, and umbilical cord blood to more complex adoptive immune therapy for the treatment of malignant diseases, and gene therapy for inherited immune deficiencies. Broader utilization of cellular therapy
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