November 6, 2025
Looking for comprehensive potency assay platforms?
MarinBio offers GMP cell based assays, ELISA, and flow cytometry.
Want advanced lot release assays?
Utilize qPCR, and transfection techniques alongside protein, and ELISA.
Need specialized lot release tests?
Perform MLR and radioimmunoassays to meet regulatory testing requirements.
Ensure the Quality, Safety, and Efficacy of Your Biologics
Potency assays are a critical component of biopharmaceutical development, providing the foundation for evaluating
product effectiveness for your projects. At Marin Biologic Laboratories, we specialize in developing, optimizing, and validating
potency assays that align with your product’s mechanism of action (MOA) and meet stringent regulatory standards..
Whether you are working with proteins, antibodies, cell therapies, gene therapies, degraders, nanoparticles or vaccines, Marin Biologic
Laboratories leverages decades of experience to deliver tailored solutions that ensure your assays are robust, reliable, and
prepared for routine application.
Do you need to develop a custom potency assay?
With a proven track record of over 30 years creating innovative potency assays for a wide range of therapeutics. We are here to provide you with stellar service for your cell based assay needs. Please call us at 415.883.8000.
We provide comprehensive support for potency assay development, ensuring expertise at every stage of the process. Our services include R&D, GLP, and GMP validation / qualification and to meet rigorous quality standards.
Our potency assay platform is expertly designed to accommodate assays tailored to client’s drugs, targets, and technologies, employing a diverse range of methods, including but not limited to:
Development of GMP Cell Based Potency Assay for the AAV-based bispecific antibody drug
We have developed a GMP-compliant cell-based potency assay tailored for an AAV-based therapeutic drug. This assay includes lot release testing to ensure quality and consistency.
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
Marin Bio has developed hundreds of potency assays over the past 30 years and can assist you in the identifying an appropriate assay specific for your drug. Some of the assays we developed have been for small molecules, antibodies, bispecific constructs, Fab products, antibody-drug conjugates, DNA and RNA, viruses, antisense moieties, recombinant proteins and stem cells. Let our scientist guide you to find the appropriate potency assay.
We offer:
MarinBio assists you throughout the drug development process, including IND/BLA applications, and commercialization.
We maintain direct interactions with the FDA, both independently and through our clients.
A GMP lot release assay, also known as lot release testing or finished product testing, is a regulatory requirement that assesses the quality and safety of licensed products before they are released for clinical use or sale. This testing is a crucial part of Good Manufacturing Practice (GMP) requirements for the production of biopharmaceutical, pharmaceutical, and medical device products.
Lot release or finished product testing is essential for ensuring the quality and safety of biologics by evaluating their purity, potency, and identity for every manufactured batch before approving its release into the market. This process also includes stability testing, which demonstrates the short and long-term stability of a biologic after exposure to various environmental factors.
For More Information about our Lot Release/Potency Assay services, please use the following informational form