IMMUNOTHERAPY ASSAYS Custom solutions for immunotherapy drug development.From idea to IND/NDA/BLA – Customized services and license free assay development for immunotherapy drug development
Immunotherapy is a biological therapy method of treating diseases by activating or suppressing a person’s own immune system. Various types of human diseases such as cancer, autoimmune diseases, allergies, graft rejection (transplant rejection), neurological diseases and viral diseases are treated with immunotherapy.
Fig. 1: Currently used immunotherapy methods
Marin Biologic Laboratories (“Marin Bio”) offers customized R&D, pre-clinical and clinical assay services for immunotherapy development. Our customized services also include development of project-based innovative solutions or technologies for our clients. Our clients own the technologies we developed for them.
This service includes regulatory compliant (GLP/cGMP) assays for potency lot release testing, bioanalysis, characterization, and stability.
| Assay type | Technique/method used |
|---|---|
| Potency assays | Cell-based assays |
| Purity | |
| Protein purity | SDS-PAGE or MALDI-TOF |
| Protein concentration | Spectrophotometry |
| Residual contaminant assays | ELISA |
| Residual DNA | q-PCR |
| Residual host cell proteins | ELISA |
| Residual host cell nucleic acids | q-PCR |
| Identity | ELISA, Dot blot, or Wester blot |
Goal: Cell-based potency assay using an Immunogene therapy drug which binds a killer T-cells to the cancer cell line and measures cancer cell killing. This experiment compares Reference Standard to Test Sample (bifunctional or bispecific antibody construct).
The effector and target cell lines are incubated at a specific effector cell-to-target cell concentration. The target cancer cells are pre-loaded with a fluorescent dye. Increasing concentrations of bispecific antibody are added. Incubation of cells with drugs is 2.5 hours and the fluorescence released into the supernatant from dead target cells is measured (Fig. 2).
Fig. 2: Cell-based potency assay using an Immunogene therapy drug
“Parts of the figure were drawn by using pictures from Servier Medical Art. Servier Medical Art by Servier is licensed under a Creative Commons Attribution 3.0 Unported License (https://creativecommons.org/licenses/by/3.0/).”
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