Therapy to PreventBronchopulmonaryDysplasia (BPD)in PretermInfants

National Center For Advancing Translational Sciences

Investigators

Abstract

A batch of research-grade peptide (AZM-152) was produced, profiled and characterized. This batch was used to begin initial drug substance stability assessments. The team also has begun to develop the bioanalytical methods that will be used to detect AZM-152 in biological samples, using the peptide to raise antibodies that will serve as key reagents in those bioanalytical assays. A process development effort has been initiated to generate the larger-scale engineering or demonstration batch, which will form the basis for subsequent drug product formulation development and to define specifications for synthesis of current Good Manufacturing Practice (cGMP)-compliant material.