Method to measure a t cell response and its uses to qualify...

G - Physics – 01 – N

Patent

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G01N 33/50 (2006.01)

Patent

CA 2508720

A method to characterize a T-cell response of a final population of T- lymphocytes resulting from the co-incubation of an initial population of T lymphocytes with a composition of antigen-presenting cells (APCs), said method comprising the steps of a) simultaneous measuring on a single cell basis at least two parameters: (i) proliferation of T lymphocytes and (ii) presence of a T cell antigen receptor on the surface of T lymphocytes and/or presence of at least one biological molecule produced by T lymphocytes, and the attribution of a positive or a negative value to each of these parameters, and b) classification of the final T-lymphocytes population into 2n different subsets of T lymphocytes, n being the number of parameters, each subset being characterized by a positive or a negative value respectively to each parameter, and the determination of the proportion of T lymphocytes present in each subset with respect to the number of T lymphocytes in the final population, with said proportion being characteristic of the T-cell response. Use of the method for batch release assay and potency assay.

L'invention concerne un procédé pour caractériser une réponse de lymphocytes T d'une population totale de lymphocytes T résultant d'une incubation associée d'une population initiale de lymphocytes T et d'une composition de cellules présentatrices de l'antigène (APCs), ledit procédé comprenant les étapes suivantes : a) mesures simultanée sur une base cellulaire simple d'au moins deux paramètres : (i) prolifération de lymphocytes T et (ii) présence d'un récepteur antigène de lymphocytes T sur la surface des lymphocytes T et/ou présence d'au moins une molécule biologique produite par des lymphocytes T, et l'attribution d'une valeur positive ou négative à chacun des paramètres ; b) classification de la population finale des lymphocytes T en deux sous-ensembles différents de lymphocytes T, n étant le nombre des paramètres, chaque sous ensembles étant caractérisé par une valeur positive ou négative correspondant respectivement à chaque paramètre, et la détermination de la proportion de lymphocytes T présents dans chaque sous-ensemble par rapport au nombre de lymphocytes T présents dans la population finale, ladite proportion étant une caractéristique de la réponse des lymphocytes T. L'invention concerne également l'utilisation du procédé pour un essai de libération par mélange et des essais de puissance.

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