Fully Continuous Purification Platform Using Nanoparticles With Ligands and Ultrafiltration



06th September 2024 | 10:00am EDT / 7:00am PDT / 3:00pm BST / 4:00pm CEST | Irina Ramos, Director, Bioprocess Technology and Engineering at AstraZeneca |BOOK FREE SEAT FOR THIS WEBINAR
  • We present on a truly continuous purification technique with potential to reduce costs-of-goods for mAbs, over conventional chromatography-based separations.
  • We demonstrate the development and proof-of-concept application of a self-assembling affinity nanoparticle to enable affinity ultrafiltration of mAb from an impure mixture.
  • This technique leverages counter current flow ultrafiltration, concentration gradients between feed and product, in a series of filters representing the phases of the process. Impurity clearance can remain high while minimizing overall buffer consumption and consequently PMI for water.
  • Overall, these data represent an early advancement toward the development of a truly continuous, counter-current, and column-free method to capture and purify mAb without expensive conjugated resins. We envision further expansion of commercially available nanoparticles towards modality and application specific designs to enable PMI savings across therapeutic areas, delivering lower cost medicines to patients.

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.


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