Home Process characterization of viral vectors: approach in CDMO context
Vol. 41 | Vol. 41(4) - July / August 2023 | PROCESS OPTIMIZATION

Process characterization of viral vectors: approach in CDMO context

by cyb2025
G. Sirgue
AAV
CDMO
Process characterization
process optimization
QbD
Viral vector

GUILLAUME SIRGUE
Head of BioManufacturing and Process Development Operations, ABL, Lyon, France

ABSTRACT

When preparing the clinical supply for product development, viral vectors manufacturers and CDMOs (Contract Development Manufacturing Organisations) have to balance complex requirements. They are expected to move very fast in a highly complex environment, while generating a comprehensive and extensive set of data to submit to Heath Authorities for review. Within the regulations, more and more emphasis is put on Quality by Design (QbD) and process characterization, but the time allocated to these is decreasing. Here, we are discussing two case studies that provide examples on how CDMOs can apply process characterization principles to deliver clinical supply and a robust data set, in due time and of the highest quality.

INTRODUCTION
Developing a therapy or vaccine that meet the Quality by Design recommendations is an ambition broadly shared within the pharmaceutical industry. QbD is also needed to create a robust process to achieve successful product development and validation. But what happens in real life when you simply do not have the time or the resources?

ABOUT THE AUTHOR

Guillaume SIRGUE holds an Engineer Degree in chemistry and biochemistry. He has spent nearly 15 years at Sanofi, developing a strong background in bioengineering, process technologies and viral vaccines industrialization.
He successively led projects in vaccine process validation, viral seed & cell bank manufacturing and USP/DSP development activities. For four years, he was Product Unit Head, in charge of daily manufacturing assistance and strategic projects for vaccine life cycle management. Since 2021, he is Head of Biomanufacturing and Process Development Operations at ABL.

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