PAT for the Future of Oligonucleotide Manufacturing

In-Situ FTIR as a Process Transform Synthesizer at Avecia

Program Overview

  • Low purities, yields, and throughputs
  • High costs and waste of raw materials
  • Complexity of the manufacturing process
  • Difficulty in scaling up the process

Avecia has played an integral role in advancing the oligonucleotide therapeutic market over the past 20 years. Avecia's experience in oligonucleotide development and manufacturing has produced over 1000 successful tract oligonucleotide sequences. Avecia's mission is to innovate and build value as customers' needs progress through drug development into commercialization. There are many process and chemistry challenges for oligonucleotide manufacturing which result in low purities, yields, and throughputs as well as high costs and waste of raw materials (amidites and solvents). In 2017, Avecia started the Technology Innovation & Improvement Management (TIIM) group focused to address these manufacturing challenges.

The presentation provides insights from the TIIM’s initiatives on the fundamental changes that Avecia is proposing and planning to implement to address these manufacturing challenges. TIIM at Avecia is currently building newer, efficient, continuous manufacturing process that are intended to reach higher purities, yields and throughputs while reducing COGS. Emerging platforms are built on new synthesizer and alternative purification technologies with full automation. PAT as an enabling technology for the future of oligo manufacturing is discussed.

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About the Presenter

dr. karsten keller

Dr. Karsten Keller

Nitto Denko Avecia

Dr. Karsten Keller is Director Technology Innovation & Improvement Management at Nitto Denko Avecia Inc. He is responsible for new technology introduction and continuous improvements in Avecia’s oligonucleotide production leading a global team for step changes in the oligonucleotides manufacturing. Previously, Karsten spent 19 years with DuPont in the Corporate Science & Innovation department and was responsible for open innovation and university relations globally. Prior to that, he was Associate Director, R&D Engineering, at the DuPont Nutrition & Health business. He has research leadership experience to innovate process technologies, ranging from nonwovens and particle technology to separation and advanced modeling. He is the inventor of over 15 patents and has published more than 100 scientific articles. He has acted as advisor to Ph.D. candidates at MIT. He is currently a process innovation adjunct professor at University Freiberg, Germany. Dr. Keller received his doctorate in chemical engineering from University of Karlsruhe, Germany.