ImmunoProfiling Lab
Flow Cytometry - Cell based Immunity
During clinical trials of vaccines or immunotherapies, studies of cell surface markers on T cells are useful for evaluating the efficacy of a drug, both in vitro and in vivo.
A custom panel of markers: Texcell offers full-service development of protocols for the cytometric measurement of specific surface or intracytoplasmic markers. We also can transfer an existing protocol into our labs. Each panel of markers is validated:
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Flow cytometry applications:
Endpoint Bioassays (Potency assays):
At each stage of development of your product, bioassays can be designed for evaluating its immune system activity.
For example, PBMCs (isolated from patients or blood donors) or cell lines can be cultivated in the presence of the drug or food supplement. At culture endpoint, intracellular cytokines or cell subpopulations (lymphocytes, macrophages, etc.) can be evaluated in order to assess the drug's efficacy.
Main Guidelines:
FDA/CDER/May 2001 “Bioanalytical method validation”
ICH S8 (EMEA/CHMP/167235/2004-ICH) Guidance for industry “S8 Immunotoxicity studies for human pharmaceuticals”
Pharmacodynamics – Cell Response:
Measurement of a drug's efficacy during clinical trials (Phases I to III). Drug efficacy can be evaluated by analysing lymphocyte subpopulations (T and B lymphocytes, NK cells, regulatory cells, memory cells, etc.) or by staining for a panel of specific surface markers (e.g. CD3, CD4, CD8, CD25, CD19, CD16, CD59, etc.).
Main Guidelines:
FDA/CDER/May 2001 “Bioanalytical method validation”
ICH S6 (CPMP/ICH/302/95) “Note for guidance on preclinical safety evaluation of biotechnology-derived pharmaceuticals”
ICH S8 (EMEA/CHMP/167235/2004-ICH) Guidance for industry “S8 Immunotoxicity studies for human pharmaceuticals”
