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HomeWebinarsA Turnkey, Flow-Through-Mode Purification Process to Improve Quality and Safety of Plasma IgG

A Turnkey, Flow-Through-Mode Purification Process to Improve Quality and Safety of Plasma IgG



WEBINAR

Plasma-derived immunoglobulins (IgG) are essential medicines that are in worldwide shortage. How to develop optimized processing steps for robust and efficient manufacturing has been a constant goal, to make the most out of the precious plasma raw material. In this study, we present a worse-case equivalent of plasma intermediate, and explore various process steps along the fractionation flow, including flow-through-mode chromatography, affinity chromatography, virus inactivation steps and removal of solvent/detergent, single-pass TFF (SPTFF), clarification, and aseptic filtration, to establish a robust, easy-to-operate, readily scalable plasma IgG process with over 99% purity, depletion of IgA, isoagglutinin, and thrombogenic markers, meeting the commonly required 20% concentration for subcutaneous IgG infusion. Such solutions would be appropriate for various IgG intermediates which help to improve the global supply of immunoglobulins.

In this webinar, you will learn:

  • Intensified plasma Immunoglobulin purifications
  • Scalable process development with the latest technologies
  • Improved safety and quality of plasma IgG meeting required quality attributes

Speakers

Josephine Cheng

Josephine Cheng

Merck

Senior Consultant, Core Modalities Asia Pacific, Bioprocessing Strategy

Josephine Cheng is our senior consultant responsible for core modalities APAC bioprocessing strategy, where she looks closely into customer and market insights in the vaccine industry and supports strategy development, and customer collaborations. With more than 13 years of pharmaceutical industry experience, she has held various regional roles in the technical and marketing field and drove business development in the plasma and vaccine fields. Josephine holds a B.S. and an M.S. in bio-resources & agriculture from National Taiwan University with a focus on protein expression, purification, and mAbs preparation.

Thierry Burnouf

Thierry Burnouf

Taipei Medical University, Taiwan

Vice-Dean, Distinguished Professor

Prof. Burnouf received his Ph.D. degree in biochemistry from the University of Lille, France. He is a world leader in the field of plasma fractionation, being at the forefront of the development and industrial implementation of new fractionation and virus inactivation and removal technologies of plasma products. His current research interest includes human platelet lysates (HPL) products for regenerative medicine and cell therapy. He has published more than 280 papers on plasma protein therapeutics in many international journals, and he is an inventor of 24 patent families.