Turning Around a Troubled Study: A Rescue Project Success Story
Time is of the essence in today’s realm of drug development, and a failed assay or behind-schedule biologic project can cost significant time and patient health or...
Women in STEM: Discussing Technology with BioAgilytix’s Whitney Gonzales this #WomensHistoryMonth
Today we continue our celebration of Women’s History Month, and the incredible contributions women have made to STEM fields in particular, by highlighting another...
Women in STEM: Discussing Science with BioAgilytix’s Dr. Jenn Zemo this #WomensHistoryMonth
March is Women’s History Month in the United States, meant as a time to remember and recognize the amazing achievements women have made over the course of history in a...
CLIA Requirements for Gene and Cell Therapy Programs
It is a common misconception that all aspects of cell and gene therapy research and development are excluded from Clinical Laboratory Improvement Amendments (CLIA)...
Bioanalytical Testing Under GMP: Assuring Biologic Safety & Efficacy via Impurities Assays
The testing of impurities – materials in biologics not related to the active form – is essential to evaluate critical quality attributes and ensure product safety...
Bioanalytical Strategies to Support Biosimilar Programs: How BioAgilytix is Helping to Shape Best Practices
A biosimilar therapeutic product is one that is highly similar to its reference product – an already-approved biological drug (the originator) – in that it has no...
A Dose of Pharma and Biotech News: December 12, 2019
With innovative research driving pharmaceutical and biotech breakthroughs, industry progress is accelerating at a rapid pace. It is important for us to stay on top of...
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. To develop a...
BioAgilytix Team Q&A: Meet Tatjana Ackermann, Quality Assurance Auditor
Career mobility is important to any motivated employee, and BioAgilytix strives to foster an environment where our team members can continually grow within their role...
CRISPR-Cas9 Milestones: The First In Vivo Clinical Trial Is Now Underway in Boston
For the first time in gene therapy history, CRISPR-Cas9 genome editing technology will be used in humans in an in vivo clinical trial in the Boston area that is set to...