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A high-performance, non-radioactive potency assay for measuring cytotoxicity: A full substitute of the chromium-release assay targeting the regulatory-compliance objective.
mAbs (2017-03-11)
Alexis Rossignol, Véronique Bonnaudet, Béatrice Clémenceau, Henri Vié, Laurent Bretaudeau
PMID28281922
ABSTRACT
Standardized and biologically relevant potency assays are required by the regulatory authorities for the characterization and quality control of therapeutic antibodies. As critical mechanisms of action (MoA) of antibodies, the antibody-dependent cell-meditated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) must be characterized by appropriate potency assays. The current reference method for measuring cytotoxicity is the
MATERIALS
Product Number
Brand
Product Description
Sigma-Aldrich
杜氏磷酸盐缓冲盐水, Modified, without calcium chloride and magnesium chloride, liquid, sterile-filtered, suitable for cell culture
Sigma-Aldrich
RPMI-1640 培养基, With L-glutamine and sodium bicarbonate, liquid, sterile-filtered, suitable for cell culture
Sigma-Aldrich
胰蛋白酶-EDTA 溶液, 1 ×, sterile; sterile-filtered, BioReagent, suitable for cell culture, 0.5 g porcine trypsin and 0.2 g EDTA, 4Na per liter of Hanks′ Balanced Salt Solution with phenol red
Sigma-Aldrich
营养混合物 F-12 Ham, With L-glutamine and sodium bicarbonate, liquid, sterile-filtered, suitable for cell culture
Sigma-Aldrich
McCoy 5A培养基, Modified, with sodium bicarbonate, without L-glutamine, liquid, sterile-filtered, suitable for cell culture
Sigma-Aldrich
Staurosporine 溶液 来源于链霉菌 属, Ready Made Solution, 1 mM in DMSO (100 μg/214 μL), 0.2 μm filtered