
Need comprehensive AAV characterization?
Perform genome titers, and residual host DNA/protein quantitation.
Developing GMP potency assays?
Custom in vitro, cell-based, or flow cytometry assays for gene therapy drugs.
Want lot release testing for viral vectors?
Develop custom stable cell lines, and GMP-compliant lot release testing.
Marin Biologic Laboratories (“Marin Bio”) offers customizable R&D, pre-clinical and clinical assay services for gene therapy development. Our customized services also include development of project-based innovative solutions or technologies. Our clients own the technologies we developed for them (certain restrictions may apply).

Cell-Based Assays for gene therapy
Immunogenicity assays
Custom stable cell line development
Production and characterization of a GMP Master Cell Bank for vector production and cell-based assays
Goal: Cell-based potency assay using an adeno-associated virus (AAV) gene therapy drug which binds a killer T-cell line to a cancer cell line and measures cell killing by Fluorescence.
Method: This experiment compares commercial Reference Standard to Gene Therapy Drug (bifunctional or bispecific antibody construct). The target cancer cells are pre-loaded with a fluorescent dye. The effector killer cell and target cancer cell lines are incubated at a specific effector cell-to-target cell concentration. Cells are incubated with increasing concentrations of bispecific antibody construct. When target cancer cells are killed, the fluorescence released into the supernatant is measured (Fig. 1).
Fig. 1: Cell-based potency assay using an adeno-associated virus (AAV) gene therapy drug

Viral Vectors
Non-Viral Methods
Gene Editing Technologies
Antisense Oligonucleotides (ASOs)
Short, synthetic strands of nucleotides designed to bind to specific mRNA or DNA molecules, blocking their transcription or translation or modifying splicing patterns.
RNA Interference (RNAi)
Uses small interfering RNAs (siRNAs) or microRNAs (miRNAs) to degrade or inhibit the translation of target messenger RNAs (mRNA).
Ex vivo Gene Therapy
Involves removing cells from a patient, genetically modifying them in the laboratory, and then reintroducing the modified cells back into the patient. Commonly used for hematopoietic stem cells and T cells.
In vivo Gene Therapy
Directly delivers genetic material into a patient’s body, targeting specific cells or tissues.
Direct Injection
Injection of genetic material directly into tissues, commonly used in localized treatments like muscle or tumor tissues.
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, cell-based assays and pre-clinical/clinical PK/PD analysis, we specialize in offering assay services that are essential for gene therapy drug development, pre-clinical studies, IND/BLA applications, and commercialization. Our comprehensive services include both preclinical non-GLP and GLP as well as non-GMP and GMP assays, providing critical support throughout the entire development pipeline. We offer:
We maintain direct interactions with the FDA, both independently and through our clients.
Gene therapy is a molecular methodology that involves altering the genes within a person’s cells to treat or prevent disease. This method can correct defective genes responsible for disease development or introduce new genes (that may be defective) into the body to combat diseases. Gene therapy specially targets genetic diseases that are challenging to treat with current methods.
There are several approaches to gene therapy, including:
For More Information about our cell based assay services, please use the following informational form