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.

Types of immunotherapy methods

1. Immune checkpoint inhibitors (Fig. 1)

2. Adoptive Cell Therapies.

  • Tumor-infiltrating lymphocyte (TIL) therapy
  • Chimeric antigen receptor T (CART)-cell therapy
  • Natural killer (NK) cell therapy

3. Monoclonal antibodies

  • Recombinant monoclonal antibodies
  • Antibody drug conjugates
  • Single chain antibodies, including bispecific antibodies

4. Oncolytic virus therapy

5. Cancer vaccines

6. Immune system modulators

  • Cytokines (e.g., interferon-alpha (IFN-α), interleukin-2 (IL-2), etc.,)
  • Bacillus Calmette–Guérin (BCG)
  • Immunomodulatory drugs

 

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.

Immunotherapy discovery, pre-clinical (non-GMP) and GMP assays we offer:

Molecular Biology & Protein Expression

  • Antibody cloning
  • Recombinant antibody expression, and purification
  • Biochemical and functional characterization of antibodies

ELISA/ Immunoassays

  • ELISA
  • Neutralizing antibody bioassays
  • Pharmacokinetics (PK) assays
  • Pharmacodynamics (PD) assays

Cell-based assays

Cancer immunotherapy T-cell assays

Immunogenicity assay

  • Anti-drug antibody (ADA) assay
  • Neutralizing antibody (NAb) assay
  • T-cell assays: Peripheral blood mononuclear cell (PBMC)- and dendritic cell (DC)- based assays.
  • Cytokine Release Syndrome Assay
  • Natural Killer (NK) Cell Assay
  • Phagocytosis Assay

Custom stable cell line development

Master cell bank

Lot release assays/tests for immunotherapy drugs

This service includes regulatory compliant (GLP/cGMP) assays for potency lot release testing, bioanalysis, characterization, and stability.

Table 1: Immunotherapy drug release testing services

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

Stability assays/tests for immunotherapy drugs

Case study: Case study Functional characterization of recombinant bispecific antibody with an in-house developed tumor cell killing assay

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

 

 

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