Development and Implementation of a Fully Automated and Integrated System to Enable Continuous Biomanufacturing on Clinical Scale

There are many excellent and well-considered reasons for implementing next generation manufacturing (NGM). We have found that, for the most part, organizations will not fund NGM unless the implementation benefits the funding organization by providing a return of cash, time or needed capability.

We will provide examples from the AstraZeneca development of NGM where the platform process proposed was based on a common framework for integrated and continuous biomanufacturing. This framework presents a new system that fully integrates and automates several unit operations, providing flexibility and easy implementation.

Here we present the optimized process fit, sterility and bioburden control strategy, and automation features that allow this equipment to be tested for 14 days of continuous end-to-end process operation at the clinical manufacturing scale. We include implementation strategy for adoption in GMP manufacturing.