From The Stage

Determining the Efficacy of Biologics Using Potency Assays Under Good Manufacturing Practice Regulations

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / Cell-Based Assays, CRO Selection

Cell-based potency assays, the central tool used to measure drug efficacy during potency testing, allow scientists to see how a particular dose of a drug will react in a given biological system. We discuss how an ideal CRO partner should approach potency assay design and validation under GMP.

CAR T-Cell Therapy: Changing the Way Cancer is Treated

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Immuno-oncology

One of the most promising types of immunotherapy uses adoptive cell transfer (ACT). While all types of ACT are in their early days of development relatively speaking, one method showing great potential is chimeric antigen receptor T-cell therapy, or CAR-T.

Strategic Bioanalytical Partnerships for the Win-Win-Win

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / Cell-Based Assays, CRO Selection

For bioanalytical CROs, it is of critical importance to build an internal team capable of meeting their pharmaceutical and biotech customers’ drug development goals. However, many overlook the benefits of strategically aligning with external partners – those organizations that can add value to the CRO’s offerings, supplementing their solutions and services to make them more comprehensive and attractive to customers.

BioAgilytix Team Q&A: Meet Matt Bray, Scientist and Bioanalytical Project Manager

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, CRO Selection

To gain a better understanding of how BioAgilytix delivers its premium bioanalytical services, it is important to know the people that drive our science. In this Q&A session, we get to know Matt Bray, Scientist/Bioanalytical Project Manager (BPM) at BioAgilytix, and how he has grown with the company since starting as our very first analyst nearly 8 years ago.

Exploratory Biomarker Testing: to Qualify or Validate the Assay?

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

There is a lot of confusion in the world of biomarker testing when it comes to the terms “assay qualification” and “assay validation”. These two terms are not strictly defined and are even used interchangeably at times. This confusion stems from the diverse scientific backgrounds and disciplines of those of us working in the biomarker field. Scientists from a manufacturing setting, clinical setting, or research setting have a somewhat different understanding of these two terms. Conversely, there is a clear distinction between “qualification” and “validation” for those working in analytical…

Modern Challenges of Single and Multiplex Biomarker Validation

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / Biomarkers, Industry Update

Biomarker validation can be confusing. We constantly hear about qualification versus validation, fit-for-purpose validation, and context of use. Due to the ‘grey area’ nature of biomarker work, many companies interpret these concepts and approaches differently. As scientists working on biomarker projects, we have to deal with a lot of variability between reagent and kit lots, high or low biomarker endogenous levels, and how to precisely assess antibody specificity in commercial kits, among other things. In a perfect world, we would have decisive guidance on how to manage all of these…