Development and Validation of a Platform Assay Method Using Variable Pathlength Technology for Oligonucleotide Drug Products
This webinar will share Ionis’ experience with developing and validating a platform SoloVPE® in-process assay method for GMP manufacturing of oligonucleotide drug products. It will describe how to develop and optimize a method suitable for oligonucleotides, the benefits compared to a previous HPLC method, method validation & transfer to CMOs and utilization of measurement system analysis to evaluate method capability.
Speaker: Ionis, Haiqing Yin, Ph.D.