From The Stage

Taking Action to Guide Effective Biosimilar Development

Dr. Dominique Gouty
Posted by Dr. Dominique Gouty / / BioAgilytix Insight, Biosimilars

The global market for biosimilars is expected to grow at an exponential rate in coming years, from only $3 billion in 2016 to a forecasted $10 billion by 2021. So, it is not a surprise that biosimilar development has continued to be a hot topic in our industry in 2017, particularly related to regulation. To secure regulatory approval for a biosimilar, the manufacturer must demonstrate that the biological product is highly similar to its reference biological product, with no clinically meaningful differences in safety, purity, and potency. But, neither FDA…

Managing Diverse Bioanalytical Talent in an Evolving Industry

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

Great people are the foundation of any successful company, and particularly when it comes to bioanalysis. Laboratories critically need the right blend of talent—including not just scientists, but also quality personnel, project leaders, etc.— to produce high quality bioanalytical results for their clients. But our ever-evolving field, combined with the realities of today’s job market and increasingly discerning preferences of job seekers and employees, can make talent management a challenge. So what practices are leading CROs using to attract, retain, and enrich talent today? Recruiting the best new people, while…

Platform Spotlight: Analyze Immunoassays on a Nanoliter Scale with Gyros

David Rusnak
Posted by David Rusnak / / BioAgilytix Insight, Bioanalytical Platforms

When it comes to large molecule bioanalysis, scientists often need to strike a delicate balance between data and time requirements: ensuring their results are as accurate and reproducible as possible, while doing so within aggressive or constraining timelines. Both sides must be upheld to avoid budget overruns or the chance that the data will be eventually rejected by regulatory agencies. Luckily, bioanalytical technology advancements are continually being made to address these pressures, and with the right platform scientific teams can more confidently deliver robust results, on time. One such example…

Investing in Emerging Bioanalytical Technologies: A Balancing Act

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Bioanalytical Platforms

Technology plays a critical part in everything we do as a bioanalytical laboratory. Ensuring that we have leading-edge platforms and instrumentation, as well as subject matter experts who can effectively operate them, are paramount concerns for our operation, so that we can capture and deliver robust, accurate scientific data in an efficient manner. When making technology purchasing decisions, there are a number of factors to consider – from cost to market needs to available talent. Each must be carefully weighed in order to maximize the ROI of any technology investments…

Influencers in the Assessment of Immunogenicity, Part 1: The Basics of Immunology

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / BioAgilytix Insight, Immunogenicity

In order to discuss the challenges and implications surrounding immunogenicity in depth, it is advantageous to have an understanding of the immunological network. Immunology and the study of immunogenicity have been the focus of most of my career, and the past decades have taught me that the immune system has impressive capabilities that can either be a challenge, or that can be harnessed to help those of us working in drug development. The Purpose of the Immune System The immune system is an incredibly intricate system of compounds and cells,…

Novel Circulating Biomarkers and Pathways May Help Predict Type 2 Diabetes More Efficiently

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers

In 2015, 29 million people in the United States had type 2 diabetes, according to the American Diabetes Association. Type 2 diabetes is generally a result of a decline in beta cell function, however this indicator is rarely measured because of flaws in the current method of assessment that can lead to inaccurate results. As such, definitively diagnosing this disease is difficult. Early intervention in those at risk for type 2 diabetes is crucial to the patient’s overall outlook for recovery or for successful disease management. Diagnosis of this disease…

Right the First Time, for the Right Results: CRO Selection is a Critical First Step

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / CRO Selection

Due to the inherent complexity of large molecule bioanalysis projects, choosing the right partner to support your study from the start is the most important step. A lack of seasoned expertise can result in costly setbacks, including delayed timelines, overrun budgets, and inadequate results. But knowledge alone is not always enough to deliver reliable assays within set timeframes; the CRO also has to have the capacity and technology needed to support efficient turnaround times and accurate, reproducible data. Let’s take a look at some of the key attributes to look…

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…