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?

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.

This question is also particularly relevant in the field of cell & gene therapies and in the CDMO context. In many cases, availability of historical data is not easy, as the products are at an early stage and process ownership can change at a fast pace. In this context ...