From The Stage

Applying Cell-Based Assays, Part 1: Neutralizing Antibody (NAb) Detection

Posted by / / BioAgilytix Insight, Cell-Based Assays

Protein-based biologic agents have the potential to induce a variety of immune responses from the body, ranging from very minor to life threatening. One such adverse immune response is generation of neutralizing antibodies (NAbs), which can bind to the biotherapeutic drug product administered and prevent it from performing its intended biologic function, in turn negatively impacting the product’s efficacy and safety profile. While standard immunoassays can be used to detect drug-specific antibodies including NAbs, they cannot distinguish NAbs from any other antibodies found. So what can we use to determine…

Clinical Impact of Immunogenicity: Lifesaving Drugs Versus the Immune System

Posted by / / Immunogenicity

The human body naturally produces antibodies to attack any potentially harmful foreign molecule. However, these antibodies cannot always tell which molecules are actually damaging invaders and which are complex drugs designed to treat life-threatening diseases. Antibodies that mistake a drug as something harmful attach to the drug and render it useless in treating the intended disease. Scientists and physicians struggle with counteracting this natural reaction because not all patients have the same immune response. The consequences of this lack of immunogenicity data appears across disease states, ranging from ineffective treatment…

Preparing for the Implications of “Brexit” in the Pharmaceutical Industry

Posted by / / Industry Update

In 2016, citizens of the United Kingdom (UK) voted in a referendum to leave the European Union (EU) by a slim margin. This departure, dubbed “Brexit” by the media, will have widespread implications for organizations that do business in the UK, especially those in highly regulated and technical industries. While all EU primary and secondary law will continue to apply to the UK until March 2019, when the withdrawal is planned for completion, pharmaceutical and biotechnology organizations must begin to prepare now for the changes that will occur. To help…

ELISA, the Most Used Immunoassay Platform in Large Molecule Bioanalysis

Posted by / / Bioanalytical Platforms

Biologics development is an inherently complex field. In order to carry out the stringent bioanalytical testing your studies require, you not only need expert scientists with a deep knowledge of your assay demands, but also the analytical resources that only a state-of-the-art laboratory can provide. At BioAgilytix, enzyme-linked immunosorbent assays, more commonly known as ELISA, is a core competency, and the technique we most commonly leverage for ligand binding assays. While the method has been in use since the 1970s, automation has helped to dramatically improve throughput and sensitivity for…