CLIA Requirements for Gene and Cell Therapy Programs
It's a common misconception that all aspects of cell & gene therapy research and development are excluded from CLIA oversight. We take a closer look…
Bioanalytical Testing Under GMP: Assuring Biologic Safety & Efficacy via Impurities Assays
We discuss the need to put phase-appropriate methods in place to identify and quantify both process- and host-cell related impurities throughout the drug development process.
Bioanalytical Strategies to Support Biosimilar Programs: How BioAgilytix is Helping to Shape Best Practices
BioAgilytix has been fortunate enough to have several of our team members participate as co-authors on all three AAPS white papers in the series on…
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. We've compiled some recent industry articles on the latest…
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…
BioAgilytix Team Q&A: Meet Tatjana Ackermann, Quality Assurance Auditor
We strive to foster an environment where our team members can continually grow within their role and within the company – not only upwards, but…
CRISPR-Cas9 Milestones: The First In Vivo Clinical Trial Is Now Underway in Boston
The first in-human in vivo clinical trial using CRISPR-Cas9 is now open for enrollment; we take a closer look at this genome editing technology to…
BioAgilytix Team Q&A: Meet Janett Schwarz, Principal Investigator at BioAgilytix
In our latest Team Q&A, we talk to Janett Schwarz, Principal Investigator at BioAgilytix’s European headquarters, about how her role has evolved since joining our…
Event Line-Up: The Bioanalytical Industry Forums We’ll Be at This Fall
We're looking forward to participating in several upcoming bioanalytical conferences and events this fall, ranging from small-circle workshops to global, world-renowned industry forums.
BioAgilytix Team Q&A: Meet Eric Nesbit, Bioanalytical Project Manager/Scientist III
In this Q&A session we talk with Eric Nesbit, Bioanalytical Project Manager/Scientist III at BioAgilytix, to learn more about what led him to leave his…