Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics

-Next generation manufacturing (NGM) for biologics is focusing on cost reduction and smaller facilities for an increased productivity. Integrated continuous bioprocess (ICB) is a powerful way to achieve that.

-A streamlined control strategy for AstraZeneca’s development of ICB to test this implementation for 14 days of continuous end-to-end process operation at the clinical manufacturing scale will be presented.

-It involves dealing with variable perfusion flow rate, normalization of dynamic perfusion titer profile, sizing between intermittent (bind-elute chromatography) and continuous (viral inactivation) unit operations, and integrating PAT when and where possible.

-Some scenarios of in-process divergences and their impact on an optimized downstream process sizing will also be included.

Presented by Irina Ramos, Director, Bioprocess Technology and Engineering 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 University of Porto (Portugal) and a PhD in Chemical & Biochemical Engineering from 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 lead process transfer efforts of the AZ COVID-19 vaccine. She has been involved with NIIMBL Process Intensification program by leading the Control Strategy workstream since 2020.

Irina has been teaching a graduate level classes on Biotechnology Master program since 2015. She is passionate about mentorship and developing resources to improve the communication of science.

Followed by Elizabeth Goodrich, R&D Technical Director at Merck

Elizabeth Goodrich is a proven team builder, people developer, and accomplished biotechnology engineer with over 30 years of experience in protein purification development and scale-up as well as system design and process automation. She currently is a Technical R&D Director in the Single-use and Integrated Systems team within Merck’s Process Solutions Division. She is focused on bringing novel and sustainable process and PAT solutions to the industry to advance productivity and performance in biomanufacturing and help accelerate the transition to intensified and continuous biomanufacturing. Ms. Goodrich holds a Bachelor of Science degree in Chemical Engineering from the Massachusetts Institute of Technology.

Kurt Boenning, R&D Engineer II at Cytiva

Kurt Boenning received his BS in Chemical and Biological Engineering from the University of Colorado. He is currently an Engineer II in the Cytiva Applications Research and Development department located in Westborough, Massachusetts. For the last 6 years, Kurt and team have covered a wide range of novel chromatography applications spanning new gene therapy modalities and process intensification with established mAb processes. Kurt leads the activities in Cytiva’s fully automated continuous lab that was developed to assess new process intensification strategies and technologies. 

Paul Gillham, Innovations Director at Optimal Industrial Technologies

Paul joined Optimal in February 2005 and has since held several different positions, including Project & Software Engineer, Technical Lead Technical Sales Manager and Product Stakeholder. Paul holds a BSc in Physics from the University of Bath and has a strong background in Software Development and Industrial Automation. He has worked with PAT for nearly two decades and has experience in areas including hands-on integration, Testing, Project Management, Sales, Product Architecture and Design.

Sponsored by Merck, Cytiva and Optimal Industrial Technologies Ltd

About Merck

Merck is a multinational leading science and technology company based in Darmstadt, Germany and active in 66 countries in 3 business sectors: Healthcare, Life Science and Electronics. Our comprehensive Life Science portfolio supports customers during all stages of the drug manufacturing process.  We offer a broad range of products and services including single-use manufacturing, filtration, chromatography and purification, virus reduction, pharma and biopharma raw materials, drug delivery compounds, and automation, control and analytics software helping you get to clinic faster, and delivering safe, effective therapies sooner to the patients that need them most.

About Cytiva

At Cytiva, our mission is to advance and accelerate the development of therapeutics. With nearly 15 000 associates in more than 40 countries, we’re driven to use our expertise and talent to achieve better flexibility, capacity, and efficiency for our customers.  Our broad and deep portfolio of tools and technologies, global scale, and best-in-class service provides critical support from discovery to delivery, for customers spanning researchers, emerging biotech, large-scale biopharma, and contract manufacturers. Learn more at cytiva.com

About Optimal Industrial Technologies Ltd

Optimal Industrial Technologies has more than 30 years’ experience in the automation and optimisation of control and data management systems for the pharmaceutical, biotech and life science industries.

Our PAT Knowledge Management software platform, synTQ®, enables real-time process monitoring and the control of critical quality attributes, non-invasively, to facilitate Quality by Design (QbD) via Process Analytical Technology (PAT).

The demands being placed on manufacturers in relation to production costs, product quality and business sustainability are ever increasing. We strive to deliver measurable improvements in these target areas.