Unraveling the Biosimilar Paradox
Riding a wave of blockbuster molecule patent expirations, the global biosimilar market grew to nearly $18 billion in 2020. With a total of 26 blockbuster…
CMC Analytical Control Strategies for Drug Development
CMC (chemistry, manufacturing, and controls) is a term used when drug developers define their investigative drug substance, establish manufacturing methods for...
PCR as a Bioanalytical Tool for Gene and Cell Therapy
The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool for gene and cell therapy. …
The Use of Cell-Based Assays for Translational Medicine Studies
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…
Women in STEM: Discussing Science with BioAgilytix’s Dr. Jenn Zemo this #WomensHistoryMonth
As part of Women’s History Month we’d like to highlight a few of the many inspiring women on the BioAgilytix team. First we’ve asked Dr.…
Bioanalytical Testing Under GMP: Optimizing Cell-Based Potency Assays
Cell-based bioassays are expected by health agencies as one of the release specification methods for potency assessments in the drug development process. We take a…