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Analytical Quality by Design approach: a challenge for Viral Vector Testing in Gene Therapy

The webinar’s topic is the methodology of Analytical Quality by Design (or AQbD) and its application to the analytical methods used at Yposkesi. Indeed, two years ago, we initiated a collaboration with Aktehom, a consulting firm specializing in healthcare industries. Initially, this collaboration allowed us to train the Yposkesi analytical team in the AQbD methodology and then to apply this methodology to two of our quantification platform methods, by digital PCR and by ELISA. We will see why and how AQbD improves knowledge of analytical methods in order to ensure their mastery throughout their life cycle. 

Watch the video to learn more about:

  • Challenges in Gene Therapy
  • Analytical Quality by Design (AQbD) Methodology
  • Application to ELISA
  • Application to digital PCR

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About the speakers:

Sophie Cheverry, Analytical Project Manager at Yposkesi:

Graduate of a biotechnology engineering school (Sup’Biotech Paris), Sophie joined Yposkesi in September 2020, initially as an analytical consultant and then as an analytical project manager. Involved in internal and external projects, she has used her technical skills in immunology, cell biology, and molecular biology to develop, improve and implement analytical methods used in gene and cell therapy.

Isabelle Moineau, Analytical Expert at Aktehom:

Holder of a doctorate in Analytical Biochemistry from the University of Lyon, Isabelle worked internationally for 15 years with major pharmaceutical industries. After this solid experience, Isabelle joined the consulting business with Aktehom. As an Analytical expert, Isabelle directs the development of innovative analytical methodologies within the framework of Aktehom offers, particularly in the operational application of Analytical Quality by Design principles within large pharmaceutical laboratories.

Created by Yerokhoff Kostyiantine