From The Stage

Supporting CAR-T Therapies, Part 1: Innovation to Overcome Bioanalytical Challenges

Dr. Corinna Fiorotti
Posted by Dr. Corinna Fiorotti / / BioAgilytix Insight, Cell Therapy

Most bioanalytical methods for canonical small or large molecule drugs utilize ligand binding or LC–MS technology for pharmacokinetic (PK) assessments. CAR-T cell therapies involve administration of ‘living drugs’ capable of proliferation after infusion. This behavior is very different from conventional drug compounds, and the term ‘cellular kinetics’ was coined for in vivo ‘PK monitoring’ of both the expansion and persistence of the genetically engineered CAR-T cells.

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

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / 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.

In Review: Evaluating the New ICH M10 Guideline Draft

Dr. Corinna Fiorotti
Posted by Dr. Corinna Fiorotti / / BioAgilytix Insight, Industry Update

As a member of Bioanalysis Zone’s recent panel discussion, Dr. Corinna Fiorotti evaluated the new ICH M10 guideline draft in terms of its practicality, language, and projected influence. Read her expert insights with accompanying video clips.

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

Jim Datin
Posted by Jim Datin / / 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?

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / 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.

510K Approved Assays vs. RUO Assays: Which Best Support Clinical Trial Biomarker Studies?

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers

The answer to the question is “it depends”. Commonly a combination of 510K approved kits (in Europe known as assays that need to follow IVD-directive 2017/746) and research use only (RUO) kits are used to support the biomarker analysis needed in clinical trials because both types of assays have different strengths and limitations. To select the appropriate kit requires an understanding of these pros and cons in the context of the intended study the assay must support.