Cell Therapy Assays

Looking for efficacy testing?
Assess activation, proliferation, target binding, killing, and custom cell-based assays.

Need GMP potency testing?
Measure effector-to-target (ET) ratios, response kinetics, and activity limits.

Want quality and safety testing?
Ensure survival, batch consistency, and reduce toxicity risks.

Cell Therapy Translational Services Offered by MarinBio

Different types of cell therapies need to be tested for desired therapeutic activity, cell effector function and potency, as well as off target toxicities, of both autologous donor and allogeneic donor products. MarinBio provides following assays to address cell therapy development needs:

3D model of antibody-cell interaction in cell therapy

Efficacy
• Effector function
• Secreted factor induction
• Activation
• Proliferation
• Differentiation
• Survival
• Target binding
• Target killing
• Immunogenicity (immune rejection of cell therapy)

Potency
• Effector to Target (ET) ratio
• Kinetics of response
• Activity limits
• Therapeutic windows

Quality
• Survival
• Maintenance of activity
• Donor comparison
• Cell batch comparisons
• Cryopreservation response

Safety
• Off target toxicities
• Off target activation
• Off target killing
• Alloreactivity
• Graft versus host disease (GVHD)
• Cytokine storms
• Hematotoxicity
• Normal cell / tissue toxicities
• Cross reactivity to target protein homologues
• Immunogenicity

Types of Cell Therapy

T Cells (Can either kill tumor cells, or can suppress immune activity)

    • Tumor Infiltrating Lymphocyte (TIL):
      Naturally occurring T cells are isolated from patient tumors, expanded and activated in culture, and infused into patients for cancer therapy.
    • Engineered T Cell Receptor (TCR):
      Tumor-specific T cell receptors (TCR) are cloned from patients. T cells are genetically engineered to express the TCR, expanded ex vivo, and infused into patients.
    • Chimeric Antigen Receptor T Cell (CAR T):
      CARs, which target proteins on tumors, are engineered and expressed on T cells, allowing them to specifically bind the target tumor cells and kill them. CAR T cells are genetically engineered ex vivo and infused into patients

CAR-Tregs (Chimeric Antigen Receptor Regulatory T-Cells)

  • Regulatory T-cells (Tregs) are engineered to express CARs. CAR-Tregs act to dampen hyperactive immune responses in autoimmune diseases, transplant rejection, and graft-versus-host disease (GVHD).

Natural Killer (NK) Cells (NK cells can kill tumor cells directly, or indirectly by binding antibodies attached to tumor cells)

  • Ex Vivo Conditioned NK Cells:
    Therapeutic infusion of large doses of ex vivo cytokine-stimulated and expanded NK cells.
  • Genetically Manipulated NK Cells:
    Genetic engineering to enhance activity and/or overcome suppressive signals followed by expansion and infusion into patients.
  • CAR NK:
    Enhanced ability to target NK cells to tumors by engineering them to express tumor-specific CARs that trigger NK cell activation and cytotoxicity.

Macrophages (Depending on how macrophages are stimulated ex vivo, they may have the ability to activate the immune system to kill tumors, or dampen immune activity to treat autoimmune disease)

  • Potential Therapeutic Indications:
    Wound healing, neurodegenerative disease, cancer, liver cirrhosis, inflammatory bowel disease, ischemic heart failure, pulmonary alveolar proteinosis.
  • Ex Vivo Conditioned Macrophages:
    Peripheral blood monocyte, or bone marrow-derived macrophages treated ex vivo to stimulate or polarize as needed based on therapeutic indication.
  • CAR M:
    Macrophages genetically engineered to target tumor-associated antigens, conditioned ex vivo, and infused into cancer patients.

iPSC-Derived Cells

  • iPSC-Derived NK Cells:
    Induced pluripotent stem cells (iPSCs) are differentiated into NK cells, which can be genetically engineered to express CARs or other modifications for enhanced anti-cancer activity.
  • iPSC-Derived T-Cells:
    iPSCs are differentiated into T-cells, which can then be engineered to express CARs or TCRs. This approach offers an unlimited source of immune cells for therapy.
  • CAR-B Cells (Chimeric Antigen Receptor B-Cells):
    B-cells are genetically modified to express CARs. These CAR-B cells can produce antibodies against specific tumor antigens and potentially enhance the anti-tumor immune response.

CAR-DC (Chimeric Antigen Receptor Dendritic Cells)

  • CAR-DCs:
    Dendritic cells are engineered to express CARs targeting specific tumor antigens. These cells can directly present tumor antigens to T-cells, enhancing the anti-tumor immune response.
Complex cellular interactions in advanced cell therapy treatments

Need Help or Have Questions on Cell Therapy 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 Cell Therapy Services?

Give us a call at 415-883-8000

Cell-Based Assay Solutions for Drug Development

With 30 years of expertise in cell culture and cell-based assays, we specialize in offering cell therapy translational assay services that are essential for IND/BLA applications and commercialization. Our comprehensive services include both non-GMP and GMP assays, providing critical support throughout the development pipeline.

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

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

Cell therapy is the transfer of specific cells into a patient to treat or prevent a disease. Cell therapy has the potential to treat multiple diseases including wound healing, neurodegenerative disease, cancer, liver cirrhosis, autoimmune and inflammatory diseases, cardiovascular disease and pulmonary diseases.

In immuno-cell therapy, different immune cell types with distinct functions are expanded and activated ex vivo, or genetically modified to improve efficacy and safety and directly infused into patients.  Immune cells under investigation as therapeutics include helper and cytotoxic T cells, gamma delta T cells (gd T cells), regulatory T cells (Treg), natural killer (NK) cells, macrophages, B cells, and dendritic cells (DC) (see below).  Each of these have distinct functional characteristics that can be modified to treat disease.

Contact Us About Our Cell Therapy Services

For More Information about our cell therapy services, please use the following informational form