Development and Validation of a Platform Assay Method using Variable Pathlength Technology for Oligonucleotide Drug Product

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:

• 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