A practical guide for pharma teams navigating the differences between GLP and GMP regulatory frameworks — covering documentation, quality assurance, facility requirements, and cell-based assay validation from preclinical development through commercialization.
Read The White PaperA comprehensive review of molecular advances transforming cancer treatment — biparatopic antibodies, next-generation antibody-drug conjugates, conditionally active antibodies, Fc domain engineering, and antibody-oligonucleotide conjugates.
Read The White PaperCompany news, inspection results and partnership announcements now live on our Press Releases page.
View Press ReleasesExplore the next generation of CAR cell therapies beyond traditional CAR-T, including CAR-NK, CAR-macrophages, CAR-iNKT, CAR-Tregs, and CAR-γδ T cells. This comprehensive guide examines how each engineered immune cell type offers unique advantages for treating cancer, autoimmune diseases, and transplant rejection. Learn how these innovative approaches overcome CAR-T limitations, from reducing toxicity and enabling off-the-shelf manufacturing to penetrating solid tumors and regulating harmful immune responses.
Read the White PaperDiscover how implementing potency assay strategies early in drug development accelerates timelines, defines Critical Quality Attributes (CQAs), and ensures regulatory success. This strategic guide demonstrates how early potency assurance reduces late-stage failures, improves product quality, and facilitates smoother FDA review processes.
Read the White PaperLearn how to select and develop the right bioanalytical assays for each phase of drug development. This comprehensive guide covers the three critical stages of assay development - fit-for-purpose, qualification, and validation - ensuring your assays meet FDA requirements from IND submission through commercialization.
Read the White PaperContact 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