From The Stage

A Dose of Pharma and Biotech News: August 9, 2017

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / Industry Update

In order to keep up with the speed of innovation in our industry, scientists at BioAgilytix are committed to keeping on the pulse of bioanalytical innovation in the pharmaceutical and biotechnology industries. We do this to keep our services innovative and to best serve our customers’ evolving large molecule needs. Here are some of the headlines we’ve been most interested in recently: Altering Genes to Beat Leukemia The New York Times, July 12, 2017 A Food and Drug Administration panel recommended that the FDA approve a treatment that genetically modifies…

Applying Cell-Based Assays, Part 2: Potency Testing for Lot Release Under GMP

Dr. Dominique Gouty
Posted by Dr. Dominique Gouty / / Cell-Based Assays

In our blog discussing the use of cell-based assays for neutralizing antibody (NAb) detection, we touched on the value that bioassays offer through their ability to closely mimic the effects that a biotherapeutic drug product will have on the body without the use of animals in the study. This is what makes cell-based potency assays the choice for measuring and validating the therapeutic activity of a drug product within prescribed ranges of safety, purity, and strength (potency), which is a requirement for regulatory submission and both clinical and commercial lot…

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

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / 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

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / 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

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / 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…

Platform Spotlight: ELISA, Still the Most Used Immunoassay Platform to Support Large Molecule Bioanalysis

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / 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…

A Dose of Pharma and Biotech News: June 28, 2017

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Industry Update

BioAgilytix’s team is committed to keeping on the pulse of bioanalytical innovation in the pharmaceutical and biotechnology industries, and sharing these insights with you, our valued colleagues and customers. Here are some of the headlines we’ve been most interested in recently: Blood Biomarker Signals Huntington’s Disease Bioanalysis Zone, June 7, 2017 Researchers from University College London (UK) recently published a study report on their search for a Huntington’s disease biomarker (HD), which found that amplified levels of neurofilament light chain circulating in the blood were present in both HD patients…

Supreme Court Decision Creates an Opportunity for Biosimilar Developers

Dr. Dominique Gouty
Posted by Dr. Dominique Gouty / / Biosimilars, Industry Update

The US Supreme Court reached a ruling last week that will allow biosimilar companies to launch new biosimilar drugs more quickly. The decision was unanimous that these companies will not need to provide the reference product sponsor with six months’ notice after US Food and Drug Administration (FDA) approval of their intention to launch a generic version of that biological drug. The case was brought to the Supreme Court over the biosimilar drug Zarxio, when the reference product sponsor and competing biosimilar developer disagreed over how language in the Biologics…

Leading the Way in Large Molecule Bioanalysis, Our Way

Jim Datin
Posted by Jim Datin / / BioAgilytix Insight, CRO Selection

What makes BioAgilytix a different kind of bioanalytical CRO? It’s all in the way we do large molecule bioanalysis, and how we work together with pharmaceutical and biotechnology companies to accelerate development of innovative biotherapeutics that can change and save patients’ lives. As you can see, our approach overcomes the common challenges that customers face when working with traditional CROs. Instead of settling for missed deadlines, little transparency, or hit-or-miss scientific quality, we take a uniquely different stance to help our customers address the most complex aspects of their large…

The Evolving Treatment of Lung Cancer: From Combination Chemotherapy to Immune Checkpoint Inhibitors

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / Immunogenicity, Industry Update

Lung cancer quickly became the most common cancer worldwide in the last decade of the 20th century due to an increase in smoking rates. 1.8 million patients were diagnosed with the disease in 2012, and in the same year 1.6 million patients died from this cancer (1). However, in the last three decades milestones in treating both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) have been met and then improved upon or superseded. The first significant milestone in treating this disease came from combination chemotherapy for…