Pharma Focus Asia

Webinar Sponsored by Repligen

solovpe-webinar

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:

  • 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

Registration Now

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?*

I would like Repligen Corporation to email me with information about events, products, services, and promotions offered in connection with the CTech™ brand and Variable Pathlength Technologies solutions.

**Under no circumstances we will share or sell your email and contact information with any govt or private entity.

Presenter:

Presenter information - Haiqing Yin , Assistant Director,Pharmaceutical Development, Ionis Pharmaceuticals

Haiqing Yin is the Assistant Director of Pharmaceutical Development for Ionis Pharmaceuticals, responsible for development, transfer and validation of the platform SoloVPE® method to support multiple early- to late-staged antisense oligonucleotide drug products manufactured at CMOs.

He has been with the company for more than two years, with over ten years of industry experience in oligonucleotide and small molecule drug product development specialized in applications of DOE and other statistical tools in formulation and process development.

He received his Ph.D. in Physical Chemistry from Peking University of China, followed by a postdoctoral training in Pharmaceutical Science from University of Utah.