
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.
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:

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
T Cells (Can either kill tumor cells, or can suppress immune activity)
CAR-Tregs (Chimeric Antigen Receptor Regulatory T-Cells)
Natural Killer (NK) Cells (NK cells can kill tumor cells directly, or indirectly by binding antibodies attached to tumor cells)
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)
iPSC-Derived Cells
CAR-DC (Chimeric Antigen Receptor Dendritic Cells)

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.

Give us a call at 415-883-8000
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.
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.
For More Information about our cell therapy services, please use the following informational form