MSD
Multiplexed Cytokine Analysis in Drug Development
Cytokines are proteins released by activated cells that serve as soluble messengers binding to target cells through surface receptors, signaling functional responses. The nature of…
The Importance of Cytokine Detection and Analysis
Cytokines are a broad class of soluble proteins, glycoproteins, and peptides that act as chemical messengers of the immune system. These small proteins are essential…
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.
C-Path “Points to Consider Document” Clarifies Bioanalytical Assay Validation in Support of Clinical Biomarker Qualification
A contributing author to the Critical Path Institute (C-Path)’s “Points to Consider Document,” Dr. Afshin Safavi summarizes considerations outlined in the paper designed to establish…
510K Approved Assays vs. RUO Assays: Which Best Support Clinical Trial Biomarker Studies?
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…