MarinBio announces publication of breakthrough research in the Journal of Immunological Methods detailing a validated, GMP/GLP-compliant cell-based potency assay for GP101, an anti-CD3-anti-CD19 diabody gene therapy targeting B-cell malignancies—supporting lot release, manufacturing consistency, and FDA regulatory submissions.
Read The Press ReleaseMarin Biologic Laboratories demonstrates critical CRO expertise in developing VNX-101, an innovative AAV-delivered immunotherapy for CD19+ blood cancers, contributing to IND-enabling studies now advancing to clinical trials.
Read The Press ReleaseMarin Biologic Laboratories announces the release of a comprehensive white paper providing the biopharmaceutical industry with a clear, scientifically grounded roadmap for selecting regulatory-ready assays that meet FDA requirements from IND to commercialization.
Read MoreMarin Biologic Laboratories has successfully completed a rigorous EU regulatory audit with full compliance confirmed, demonstrating our commitment to meeting the highest global standards for quality and regulatory excellence.
Read MoreMarin Biologic Laboratories and Emery Pharma have announced a strategic partnership to enhance their drug development services.
Read MoreMarin Biologic Laboratories has successfully passed a surprise FDA inspection for the second consecutive year with no observations, further solidifying its reputation for excellence in biopharmaceutical services.
Read MoreMarin Biologic Laboratories successfully passed an FDA inspection, reaffirming its compliance with cGMP standards.
Read MoreContact 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
For More Information about our Protein/Antibody services, please use the following informational form