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, 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 an implementation strategy for adoption in GMP manufacturing.

Presented by Irina Ramos, PhD, Director of Downstream Continuous Manufacturing, in the Bioprocess Engineering and Technology Group at AstraZeneca

Irina Ramos is a director of downstream continuous manufacturing in the Bioprocess Engineering and Technology group at AstraZeneca in Gaithersburg, MD, USA. She has been a key driver of the technology development and implementation strategy for continuous biomanufacturing. Her team works to increase fundamental understanding of the various downstream unit operations of drug substance manufacturing. They manage the design, testing, and qualification of process equipment and automation on the systems to integrate them.
Irina holds a BS/MS in Chemical Engineering from the University of Porto (Portugal) and a PhD in Chemical and Biochemical Engineering from the University of Maryland, Baltimore County (UMBC).
For the past 14 years, Irina’s work in the pharmaceutical industry has spanned from early to late-stage process development and validation, process scalability, CMC, and technology transfer to both clinical and commercial manufacturing. With that experience, Irina led process transfer efforts for the AZ COVID-19 vaccine. She has been involved with the NIIMBL Process Intensification program by leading the Control Strategy workstream since 2020.
Irina has been teaching a graduate-level class on Principles of Downstream Processing since 2015. She is passionate about mentorship and developing resources to improve the communication of science.

Followed by Britta Anderson, Senior Program Manager at Merck

Sponsored by Merck