Author: Guillaume SIRGUE, Head of BioManufacturing and Process Development Operations, ABL, Lyon, France

Article published in Chimica Oggi-Chemistry Today (July/August 2023)

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.

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