Process characterization of viral vectors: approach in CDMO context

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?

The focus on these recommendations is more important than ever, as regulators have broadly transposed ICH (International Council for Harmonisation) Q8 expectations in local regulations (1). Scientists should also show great interest in this methodology, as it helps in rationalizing the development effort while making process understanding as broad as possible. However, those activities are time-consuming and might not be accessible when, to secure funding, clinical proof needs to be obtained quickly.