From The Stage

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

Posted by / / 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

Posted by / / 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

Posted by / / Cell-Based Assays

In our blog discussing the use of cellular 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…