IMMUNI T provides GLP/GCLP compliant bioanalysis services using ligand-binding methods (ELISA, MSD-ECL, HL-ELISA). Peptide/protein/oligonucleotide-based drug detection and measurements for PK/PD analysis and detection of ADA for immunogenicity analysis are being performed under the relevant regulations. If necessary, neutralizing assays are developed as part of the immunogenicity study. Instruments are installed and operated under GLP guidance (IQ/OQ) and all phases of the method validation and sample analysis studies are QA audited.

 

 

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Method Development

A method can be designed and developed from no original protocol, using a commercial kit or from a method transfer. The method development includes an optimization phase and a preliminary check of the validation parameters (pre-validation). A common critical aspect is the qualification of the analyte performance in the matrix of interest. Once all the criteria are met, method validation is initiated.

 

Method Validation

The method validation of a PK assay includes 1. assessment of specificity (using 1a. interference check/selectivity and 1b. dilution linearity), 2. working calibration range, 3. lower and 4. upper limit of quantitation (LLOQ and ULOQ), 5. inter-assay accuracy and precision and 6. stability tests (freeze/thaw and bench-top stability). The long-term stability assessment is performed separately and the extent of the stability period tested is based on the sponsor specific requirements.

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The method validation of an ADA (Anti-Drug Antibody) assay includes:

1. Determination of the minimal required dilution (MRD);

2. Selectivity and sensitivity assessment;

3. Accuracy and precision tests;

4. Drug tolerance/competition;

5. Determination of the cut point.

By design, a rate of 5% false positive is observed. A confirmatory assay is developed and validated in order to confirm a positive sample by competition assays and titer. The long-term stability assessment, if necessary, is performed separately and the extent of the stability period tested is based on the sponsor specific requirements. True positive samples are then tested in a cell-based neutralizing assay to determine if the observed signal is caused by a neutralizing antibody (Nab).

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Sample Analysis

The validated method is then utilized to analyze pre-clinical or clinical samples. Immuni T has implemented procedures for all phases of the studies, including sample and test item (TI) management (reception, storage, use in study and return or elimination) with a full chain of custody. The final bioanalytical report is submitted in a format suitable for regulatory submission.

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IMMUNI T also provides sample analysis based on its flow cytometry and Luminex platforms.