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Oligonucleotide CMC

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Oligonucleotide CMC

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On Demand - For MembersFree
On-Demand Presentations
Characterization of the Diastereoisomeric Composition of Phosphorothioate Oligonucleotides
  • Claus Rentel, PhD - Executive Director, Analytical Development/QC, Ionis Pharmaceuticals, Inc.
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Whitepapers & Case Studies
WHITEPAPER: From Research to Commercial Quantities: A Seamless Supply of Oligonucleotides
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    Interviews
    Boosting Commercialization of Oligonucleotides as a Raw Materials Supplier with Aldevron
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      Scientific Posters
      Large Scale Manufacturing for Oligonucleotide API
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        CASE STUDY: Scaling Up Manufacturing When it’s Needed Most
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          Interviews
          Oligonucleotides @ Bachem - Interview with Torsten Wöhr
          • Torsten Wöhr, Ph.D. - Head of Oligonucleotides, Bachem AG
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          The Evolution of Regulation for Oligonucleotide Therapeutics: Regulatory Agency Perspectives
          • René Thürmer, PhD - Deputy Head, Unit Pharmaceutical Biotechnology, BfArM Federal Institute for Drugs and Medical Devices
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          Whitepapers & Case Studies
          WHITEPAPER: Oligonucleotide Purification and Analysis: A Chromatography Overview
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            On-Demand Presentations
            Regulatory Considerations for Setting Smart Starting Material Specifications
            • Dominik Altevogt, Ph.D - Pharma Technical Regulatory Manager, F.Hoffmann-La Roche Ltd
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            Whitepapers & Case Studies
            WHITEPAPER: Oligonucleotide API Manufacturing and CMC Services
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              On-Demand Presentations
              Learnings from Process Validation of an Oligonucleotide and Plans for Leveraging the Platform in the Future
              • Jesse Faber - Senior Engineer III, ASO Process Engineering and M, Biogen
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              On-Demand Presentations
              Introduction into Identity Testing Strategies and Development of a Sequence Sensitive Method Using In-source Fragmentation on A Low-resolution LC-MS Instrument
              • Tom Atherton, Ph.D. - Senior Scientist, GlaxoSmithKline
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              On-Demand Presentations
              Doing an IND with An NDA in Mind: Planning for Regulatory Interactions
              • Jennifer Franklin - Director, CMC Regulatory Affairs, Ionis Pharmaceuticals
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              On-Demand Presentations
              Switching Gears, From Early Stage Development to Late Stage Validation in 4 Years
              • Hans Kistemaker, PhD - Senior Scientist, Chemistry & Manufacturing, ProQR Therapeutics
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              On-Demand Presentations
              Accelerated Stability Assessment of Oligonucleotides
              • Mark Madsen, PhD - Assistant Director, Analytical Development & Quality Control, Ionis Pharmaceuticals
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              On-Demand Presentations
              From Amidites to Drug Product: Quality Control Analysis of Oligonucleotide Therapeutics
              • Carolyn Mazzitelli - Associate Director, Ionis Pharmaceuticals
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              On-Demand Presentations
              Phase Appropriate Analytical Control Strategies for Oligonucleotides
              • Jessica Stolee, PhD - Associate Director, Pharma and ASO Analytical Deve, Biogen
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              On-Demand Presentations
              Overview of Current Technical Challenges in Oligonucleotide CMC
              • Marc Lemaître, PhD - Chief Operating Officer / Principal, Sirnaomics, Inc. / ML Consult
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              On-Demand Presentations
              Liquid Phase Synthesis of Oligonucleotides
              • Andrew Livingston - Professor of Chemical Engineering, Imperial College London
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              On-Demand Presentations
              Advances in the Chromatographic Purification of Oligonucleotides
              • Andrew Rodriguez, PhD - Assistant Director, Process Chemistry, Ionis Pharmaceuticals
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              On-Demand Presentations
              Control of Impurities and Overall Purity in GalNAc siRNA Conjugates
              • John Richards, Ph.D. - Global Drug Development/Technical Research & Development, Novartis
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              On-Demand Presentations
              QBD and DoE Approaches to Oligos – Applications for Process Robustness
              • Thomas Emery - Associate Scientist, GSK
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              On-Demand Presentations
              Early Phase CMC and Regulatory Strategy for Oligonucleotides
              • Marc Lemaître, PhD - Chief Operating Officer / Principal, Sirnaomics, Inc. / ML Consult
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              On-Demand Presentations
              A Platform Stability Strategy for Anti-Sense Oligonucleotides: Part I - ASO Degradation Study and Predicative Stability Modelling
              • Jiangwei Li, PhD - Scientist, Analytical Development, Biogen
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              On-Demand Presentations
              A Platform Stability Strategy for Anti-Sense Oligonucleotides: Part II - ASO program ICH Stability and Future Platform Strategy
              • Philip Pue-Gilchrist - Scientist, Analytical Development, Biogen
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              On-Demand Presentations
              “Points-to-Consider” When Planning Your First Oligonucleotide Drug Product Campaign
              • Stefan Vonhoff, Ph.D. - Vice President CMC, NOXXON Pharma AG
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              On-Demand Presentations
              Terminal Sterilisation of Oligonucleotide Drug Products
              • Angela Wagner, PhD - Associate Principal Scientist, Sterile & Specialty, Merck Sharpe & Dohme
              NextOligonucleotide Discovery
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