From The Stage

A Dose of Pharma and Biotech News: December 12, 2019

Posted by / / BioAgilytix Insight, Industry Update

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 topics to share with you.

Bioanalytical Testing Under GMP: Optimizing Cell-Based Potency Assays

Posted by / / Uncategorized

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 closer look at the inherent complexities that come with developing these assays under GMP, and ways they can be overcome.

BioAgilytix Team Q&A: Meet Tatjana Ackermann, Quality Assurance Auditor

Posted by / / BioAgilytix Insight, CRO Selection

We strive to foster an environment where our team members can continually grow within their role and within the company – not only upwards, but also into positions they come to find most suited to their unique skills and interests. In this Team Q&A session, we talk to Tatjana Ackermann, Quality Assurance Auditor, about her career path at BioAgilytix since starting in our European lab five years ago.

Your Questions About Exploratory Biomarker Testing Answered

Posted by / / BioAgilytix Insight, Biomarkers

Many great questions were asked by our audience during Dr. Afshin Safavi’s recent webinar on exploratory biomarker testing. We've compiled his answers those he didn’t have time to address during the live session.

BioAgilytix Team Q&A: Meet Jelle Hempenius, Business Development Director, Europe

Posted by / / BioAgilytix Insight, CRO Selection

Did you know that BioAgilytix’s ‘deep bench’ extends beyond those we have working in the lab? Many individuals in our operational departments, from business development to QC, are also formally trained scientists with extensive in-lab experience. One such team member is Jelle Hempenius, who recently joined BioAgilytix as Business Development Director, Europe.

Webinar Sneak Peek: Exploratory Biomarker Testing—to Qualify or Validate the Assay?

Posted by / / BioAgilytix Insight, Biomarkers

Biomarkers are endogenous molecules with much individual variability, and there is still not yet one clear and concise guidance for biomarker validation – so there are still questions around what it takes to sufficiently validate the performance characteristics of a biomarker assay to ensure it can properly establish the value of the target biomarker as a qualified DDT.