WhoshouldIsee Tracks

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

Webinar Overview

  • 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.

This webinar is copyright of Biopharma Webinars. https://biopharmawebinars.com/

Details correct at time of webinar recording.

 

Speakers:

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.

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 by SciY

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.