Immuni T is a contract research organization (CRO) providing high quality services in immunology. Immuni T can perform the immunogenicity prediction for new biotherapeutics; ligand-binding/Luminex assays for the quantification/detection of peptides and proteins; cytotoxicity or other cell-based functional assays, immuno assays and cell phenotyping based on flow cytometry analysis for determination of cell function and molecules quantification; as well as customization, development and validation of assays for clinical sample analysis in a GLP-compliant environment.
Immuni T develops and validates immunogenicity methods (ADA detection) and performs proliferation tests that are used for comparing the immunogenic potential of a molecule to that of known molecules, thus providing a tool for assessing the potential immunogenicity of a biologics during its development.
Standard antidrug antibody (ADA) assays:
Immunogenicity prediction before the first human dosage can comprise various characterization tools:
Critical immunogenicity: assay parameters:
An Oligonucleotide drug candidate requires both a sensitive and reliable bioanalytical method; not only for use in plasma samples, but also in solid tissues, such as liver, kidney, skin, or brain. Sensitive assays are required for the lower therapeutic doses that are currently being administered as more effective drug regimens with higher potency and targeted delivery are developed. The bioanalytical method has to be selected taking into account any chemical modifications in the structure as well as the functionality of the therapeutic oligonucleotides. Numerous classes of therapeutic oligonucleotides compounds exist, including:
Hybridization assays are currently one of the most sensitive quantitative methods available for the determination of oligonucleotides achieving limits of quantitation down to the pg/mL level in a variety of different biological matrices including solid tissues. A number of different hybridization assay formats exist depending on the nature of the oligonucleotide drug candidate, however all of the assays work by exploiting the highly specific binding of the complementary oligonucleotide probe to the drug candidate, via Watson-Crick base-pairing.
Hybridization assay services
Our research and development group supports method transfer, development, and validation of hybridization assays for the determination of oligonuclotide therapeutics, as well as the subsequent analyses of study samples in support of regulated pre-clinical, and clinical studies.
Development and validating assays:
Sample analysis is conducted in compliance with the current Regulatory Guidance's and White Papers applicable to the quantitative determination of drug therapeutics in biological fluids using ligand binding assays. The final bioanalytical report will be in a format suitable for regulatory submission.
Methods include standard toxicity studies (STS) and additional immunotoxicity studies conducted as appropriate. Whether additional immunotoxicity studies are appropriate should be determined by a weight of evidence review of various factor(s).
Immunotoxicology analytical data packages may comprise:
Immunotoxicology functional data packages may include:
Additional studies are often composed but not limited to : T cell dependant antibody response, immunophenotyping, natural killer cell assay and various other cell functions, including cell mediated immunity.
We have expertise and experience in:
We offer a comprehensive range of in vivo,ex vivo and in vitro approaches:
We offer a custom tailored approach to answer your specific immune system questions through:
We also perform:
Methods & Process Development & Validation;
IMMUNI T has not received any reviews.
IMMUNI T has not received any endorsements.