On this episode of Molecular Moments, Lynn Kamen, Ph.D., and Michelle Miller, Ph.D. DABT discuss their very different journeys to
Chimeric Antigen Receptor (CAR)-T cell therapy is a novel cancer therapy that harnesses and redirects the cytotoxic activity of T cells against cancer cells. CAR-T cells are generated by engineering T cells to express a chimeric antigen receptor, which is typically an antibody directed against a target on the cancer cell, fused with TCR signaling components. Several CAR-T cell products have been approved for treatment of hematological cancers, and there
Gene therapy is a powerful form of treatment that involves introducing genetic material into cells to replace defective genes resulting in the production of an essential protein. If a defective gene causes a required protein to be faulty or absent, gene therapy may be able to restore the protein’s function by introducing a “healthy” copy of the gene. Since gene therapy products work by introducing genetic material into the cell,
The concept of using pre-existing immunogenicity as an exclusion criteria for gene therapy clinical trials is changing. BioAgilytix’s Chief Scientific Officer, Dr. Jim McNally, explores why.
When you have a program that has stalled or gone off schedule, it is vital to team up with a CRO laboratory that is capable of handling quick turnarounds and rescue projects. We look at an example of how BioAgilytix sprung to action to transform a troubled study.
On May 7, we’ll be hosting webinar highlighting the importance of streamlining the time & cost of bioanalytical testing to support therapeutic development for viral infections such as COVID19 and influenza. We share a sneak peek of the content here.
BioAgilytix’s Todd Lester answers additional questions submitted by attendees of his recent Bioanalysis Zone webinar on immunogenicity testing for biosimilars.
BioAgilytix’s Todd Lester answers questions submitted by attendees of his recent Bioanalysis Zone webinar on immunogenicity testing for biosimilars.
On January 23rd I’ll be hosting a webinar with Dr. Dominque Gouty that will summarize key insights from the recently published paper by the American Association of Pharmaceutical Scientists (AAPS) entitled “Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs”. I had the privilege to contribute as an author on this pivotal paper, which lays out a consensus recommendation for use of a one-assay approach
The observation of drug-specific IgE antibodies which may cause anaphylaxis prompts the need to test for these antibodies – but because IgE are 2000-fold less prevalent than IgG antibodies, a very sensitive detection method is required. We discuss why the ImmunoCAP platform provides an ideal system to analyze IgE-mediated drug hypersensitivities.
What are the advantages of using the Biacore™ T200 SPR System for immunogenicity assessments with a tiered approach? Our experts discuss.