Immunotherapy Assay

Developing functional cell-based assays?
Explore activation, cytotoxicity, and proliferation assays for robust immunotherapy insights.

Optimizing cancer immunotherapy assays?
Achieve precise cytokine, T-cell, and MLR assay results with expert guidance.

Need GMP-compliant services?
Develop potency, stability, and lot release testing with master cell bank production.

Immunotherapy Assay Services Offered by MarinBio

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

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

Cell-Based Assays

  • T cell activation assays
  • Monocyte/macrophage, NK cell and granulocyte activation bioassays
  • Drug or target-specific functional assays
  • Reporter assays
  • CTL, Cytotoxic T-Lymphocyte killing bioassays
  • Flow Cytometry bioassays for proliferation and surface marker differentiation
  • MLR, Mixed Lymphocyte Reaction bioassays
  • ADA, Anti-Drug Antibody inhibiting drug action (also see ELISA page)
  • ADCC, Antibody-Dependent Cellular Cytotoxicity bioassays
  • CDC or CMC, Complement-Dependent Cytotoxicity or Complement Mediated Cytotoxicity bioassays
  • Oxidative Stress and Nitrosative Stress bioassays

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

Potency Assays    

Stability Testing  

Lot Release Testing

Master Cell Bank

  • Production and characterization GMP Master Cell Bank for immunoassay, cell-based assays, and vector production.

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 Immunogen Therapy Drug (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. 1).

Fig. 1: Cell-Based Potency Assay using an Immunogene Therapy Drug

Graph comparing fluorescence levels of an immunogene therapy drug versus a standard treatment, showing drug efficacy in a dose-response curve.

Immunotherapy Methods

Immune checkpoint inhibitors: Drugs that help to activate the immune system to recognize and attack cancer cells by blocking the proteins that inhibit immune responses (checkpoint inhibitors). 

 Adoptive Cell Therapies: Types of immunotherapy that involves extracting, modifying, and infusing a patient’s immune cells to help fight cancer and other diseases.

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

Monoclonal Antibodies:

  • Recombinant monoclonal antibodies (scFv, Fab, VHH)
  • Bi- and Tri-specific antibodies
  • T cell engagers
  • Immuno-cytokines
 

Antibody Drug Conjugates (ADCs): A class of targeted cancer therapies that combine the specificity of monoclonal antibodies with the potent cell-killing ability of cytotoxic drugs.

  • Single chain antibodies, including bispecific antibodies
 

Oncolytic Virus Therapy: Involves using genetically modified viruses to selectively infect and destroy cancer cells while stimulating an anti-tumor immune response.

 Cancer Vaccines: These are designed to stimulate the immune system to recognize and target specific cancer-associated antigens, helping to prevent or treat cancer.

Immune System Modulators: Agents that modify the immune response by enhancing or suppressing the body’s immune activity.

  • Cytokines (e.g., interferon-alpha (IFN-α), interleukin-2 (IL-2), etc.)
 

 Immunomodulatory Drugs: Immunomodulatory Drugs (IMiDs) modify the immune system’s response, either by enhancing or suppressing its activity, to treat various conditions, including cancer and autoimmune diseases.

Gene Therapy: Modifying a patient’s immune cells to enhance their ability to recognize and attack cancer cells, providing a targeted and effective treatment option.

Scientist pipetting sample for immunotherapy assay

Need Help or Have Questions on Immunotherapy Assay Services?

Contact us to discuss the specifics of your project. Our team of experienced scientists is ready to assist you with tailored solutions to meet your unique needs. Whether you need help with assay development, FDA IND, stability study,  lot release approval, or other scientific endeavors, we are here to support you.
Contact us to learn more about our cell based assay services

We will initiate your project as soon as the proposal is approved and signed by you. Our streamlined process ensures a quick start, minimizing delays and maximizing efficiency. Fill out the form below to email us or click our live chat option to speak with a MarinBio Scientist and get your project underway.

Yes, we have over 30 years of expertise in developing and validating cell based assays for FDA IND, lot release or stability study approval. Our team can also liaise directly with the FDA on your behalf, ensuring a smooth and compliant process. Please contact us to learn more about how we can assist you with your assay development and FDA approval needs.

MarinBio scientists are experienced and creative in designing, developing, validating assays. Some of the assays we perform are listed below, but there are many more that we created, developed and validated. Give us call so that we may help you.

MarinBio scientists conducting targeted protein degradation assays in advanced laboratory

Need Help or Have Questions on Immunotherapy Assay Services?

Give us a call at 415-883-8000

With 30 years of expertise in immunology, immunoassays, and cell-based assays, we specialize in providing cell immunotherapy assay services vital for drug development, pre-clinical studies, IND/BLA applications, and commercialization. Our extensive offerings include both non-GMP/GLP and GMP/GLP assays, delivering essential support throughout the development pipeline. We offer:

  • Unmatched quality
  • Prompt timeliness
  • Cost-effective solutions
  • Exceptional communication

We maintain direct interactions with the FDA, both independently and through our clients.

Immunotherapy activates or suppresses a person’s own immune system to treat disease. Immunotherapy enhances or modifies the immune system to help it recognize and attack disease cells such as cancer cells. The immune system is a complex network of cells, tissues, and organs that defends the body against infections and other invaders. Various types of human diseases such as cancer, autoimmune diseases, allergies, graft rejection (transplant rejection), neurological diseases and viral diseases are treated with immunotherapy.

Contact Us About Our Immunotherapy Assay Services

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