Ligand Binding Assay
CMC Analytical Control Strategies for Drug Development
CMC (chemistry, manufacturing, and controls) is a term used when drug developers define their investigative drug substance, establish manufacturing methods for...
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…
Is ISR Needed For Biomarker Assays?
Incurred sample reanalysis (ISR) is a well-established measure for the reproducibility of pharmacokinetic (PK) assays and commonly conducted in regulated studies. ISR was established in…
Cell and Gene Therapies Account for a Large Portion of the Therapeutics Market
Cell and gene therapies have gone through a growth spurt in the last decade. According to data from the Alliance for Regenerative Medicine (ARM), during…
CMC Requirements for Cell and Gene Therapy for IND Applications
The U.S. Food and Drug Administration (FDA) has issued Chemistry, Manufacturing, and Control (CMC) recommendations for Investigational New Drug (IND) applications for human investigational gene…
Answering Your Questions on Developing a Relative Potency Assay for an Anti-Influenza mAb
Dr. Jeff Patrick answers questions on how BioAgilytix translated a diagnostic virus neutralization method to a quantitative relative potency assay for an anti-viral antibody.
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…
To the Rescue: Applying a Novel Approach to Minimize False Positive ADA Assay Results
Target interference can cause false positive ADA assay results and stall out promising drugs. This could have been the case for one study involving an…
Ligand-Binding Assay Optimization, Part 1: Critical Attributes of Platforms Used
Consistent discussion and improvement upon the standard practices of bioanalytical laboratories is critical to improving the work we do supporting innovative biologics development in the…