Development and Validation of a Platform Assay Method Using Variable Pathlength Technology for Oligonucleotide Drug Products

Previously Aired on October 5th, 2021

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The CTech™ SoloVPE^® System uses a patented variable pathlength technology to accurately measure concentration. Would you like a Repligen analytics specialist to contact you to learn more about the SoloVPE System?

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Overview

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.

What you will learn:

The benefits of implementing the CTech™ SoloVPE® using variable pathlength technology as a platform assay method for GMP manufacturing of oligonucleotide drug products
How to overcome challenges due to unique characteristics of oligonucleotide and optimize the method to achieve desirable accuracy and precision
How to validate the method in accordance with ICH guidance and utilize measurement system analysis (MSA) to further access the method capability

Who should attend:

Individuals responsible for maximizing operational expense cost in:

Drug Development
Quality Control
Manufacturing/Operations
Operational Excellence/Lean Improvement

Presenters

Haiqing Yin

(Presenter)
Assistant Director, Pharmaceutical Development,
Ionis Pharmaceuticals
View Biography

Mike Auerbach

(Moderator)
Editor-in-Chief,
American Pharmaceutical Review