Immunogenicity

Basic Principles of LC/MS Methods Liquid Chromatography-Mass Spectrometry (LC/MS) is a technique that involves the physical separation of target analytes followed by their mass-based detection.…

Entering the biosimilars market is an enticing prospect for many biopharma companies, offering the potential for reduced development and manufacturing costs while providing patients with…

3 key challenges facing the biosimilars space in 2023 In 2010, the biopharma industry saw an abrupt patent cliff: a significant number of top-selling drugs…

Neoantigens are novel proteins that form on cancer cells following the development of mutations in the tumor-cell DNA. These proteins are new to the immune…

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…

Cell-based assays are an important tool in drug development. One of the biggest challenges when developing a drug is mimicking the appropriate physiological setting to predict…

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…

Cell-Based NAb Assays So, how do we deal with NAbs when it comes to the industrial production of biotherapeutic agents? The bioanalytical community adopts a…

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…

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…