FIELD: medicine, pharmacy.
SUBSTANCE: invention refers to biotechnology. Method for Clostridium botulinum (BoNT) neurotoxin activity analysis is described, comprising: contact of the neuronal cell derived from the human induced pluripotent stem cell (hiPS) with a composition comprising BoNT and analysis of the said BoNT biological activity by determining the presence or absence of BoNT substrate cleavage in the neuronal cell subjected to contact, and/or the presence or absence of neurotransmitter release from the neuronal cell subjected to contact. Also, a method for BoNT neurotoxin activity analysis is described, comprising: contact of the neuronal cells derived from the human hiPS with a composition comprising BoNT and a neutralizing antibody, and analysis of the said BoNT biological activity by determining the presence or absence of BoNT substrate cleavage in the neuronal cell subjected to contact, and/or the presence or absence of neurotransmitter release from the neuronal cell subjected to contact. Also, a method is proposed for biologically active BoNT amount determination in the preparation by contact of active BoNT derived from hiPS with the sample preparation and determination of the active BoNT amount, present in the formulation, by determining the presence or absence of BoNT substrate cleavage in the neuronal cell subjected to contact, and/or the presence or absence of neurotransmitter release from the hiPS-derived neuronal cell subjected to contact. Also neuronal cells derived from human induced pluripotent stem cell (hiPS) human application for BoNT activity analysis is disclosed.
EFFECT: invention is highly sensitive analysis for detection and/or analysis of BoNT neurotoxin in a sample using neuronal cells derived from human IP as a highly sensitive and reproducible platform for botulinum neurotoxin detection.
23 cl, 9 dwg, 1 ex
