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Oligonucleotide CMC

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Oligonucleotide CMC

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OLIGONUCLEOTIDE CMC: Comprehensive CMC, analytical, manufacturing and regulatory strategies for both drug substance and drug product to accelerate oligonucleotide product development.
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.
On Demand - For MembersFree
Webinars
Advancing and Enabling Commercial-Scale Manufacturing of Nucleic Acid Based Medicine
  • Anil Kore - Director, Chemistry & Biology, Thermo Fisher Scientific
On Demand - For MembersFree
Whitepapers & Case Studies
WHITEPAPER: From Research to Commercial Quantities: A Seamless Supply of Oligonucleotides
    On Demand Free
    Interviews
    Boosting Commercialization of Oligonucleotides as a Raw Materials Supplier with Aldevron
      On Demand - For MembersFree
      Scientific Posters
      Large Scale Manufacturing for Oligonucleotide API
        On Demand - For MembersFree
        Whitepapers & Case Studies
        CASE STUDY: Scaling Up Manufacturing When it’s Needed Most
          On Demand - For MembersFree
          Interviews
          Oligonucleotides @ Bachem - Interview with Torsten Wöhr
          • Torsten Wöhr, Ph.D. - Head of Oligonucleotides, Bachem AG
          On Demand - Premium Only
          On-Demand Presentations
          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
          On Demand - For MembersFree
          Webinars
          Oligonucleotide Manufacturing from Small to Large Scale
          • Toru Okamatsu - Manager of Business Development, Ajinomoto Bio-Pharma Services
          On Demand - For MembersFree
          Whitepapers & Case Studies
          WHITEPAPER: Oligonucleotide Purification and Analysis: A Chromatography Overview
            On Demand - Premium Only
            On-Demand Presentations
            Regulatory Considerations for Setting Smart Starting Material Specifications
            • Dominik Altevogt, Ph.D - Pharma Technical Regulatory Manager, F.Hoffmann-La Roche Ltd
            On Demand - For MembersFree
            Webinars
            Sample Preparation Strategies for Oligonucleotide Bioanalytical Workflows
            • Brian Rivera - Senior Product Manager- Biologics, Phenomenex
            On Demand - For MembersFree
            Whitepapers & Case Studies
            WHITEPAPER: Oligonucleotide API Manufacturing and CMC Services
              On Demand - Premium Only
              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
              On Demand - For MembersFree
              Webinars
              New Oligonucleotide GMP Manufacturing Facility from API to Filling & Finishing
              • Michael Zhang - Business Development Manager, RiboBio Co.
              On Demand - Premium Only
              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
              On Demand - For MembersFree
              Webinars
              LGC’s Development of a Novel, Modular, GalNAc Access, and Conjugation Strategies for Nucleic Acid Medicines
              • Catherine McKeen - Site Operational Director & Head of Chemistry, LGC Group
              • Juergen Mueller, PhD - Commercial and Strategic Development Director Oligo-therapeutics, LGC Axolabs
              On Demand - Premium Only
              On-Demand Presentations
              Doing an IND with An NDA in Mind: Planning for Regulatory Interactions
              • Jennifer Franklin - Director, CMC Regulatory Affairs, Ionis Pharmaceuticals
              On Demand - For MembersFree
              Webinars
              Preparative Separation of Oligonucleotide by Ion-Exchange and Hydrophobic Interaction Chromatography
              • Oscar (Yosuke) Yamasaki - Product Management Unit, Bioscience Division, Tosoh Corporation
              On Demand - Premium Only
              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
              On Demand - Premium Only
              On-Demand Presentations
              Accelerated Stability Assessment of Oligonucleotides
              • Mark Madsen, PhD - Assistant Director, Analytical Development & Quality Control, Ionis Pharmaceuticals
              On Demand - Premium Only
              On-Demand Presentations
              From Amidites to Drug Product: Quality Control Analysis of Oligonucleotide Therapeutics
              • Carolyn Mazzitelli - Associate Director, Ionis Pharmaceuticals
              On Demand - Premium Only
              On-Demand Presentations
              Phase Appropriate Analytical Control Strategies for Oligonucleotides
              • Jessica Stolee, PhD - Associate Director, Pharma and ASO Analytical Deve, Biogen
              On Demand - Premium Only
              On-Demand Presentations
              Overview of Current Technical Challenges in Oligonucleotide CMC
              • Marc Lemaître, PhD - Chief Operating Officer / Principal, Sirnaomics, Inc. / ML Consult
              On Demand - Premium Only
              On-Demand Presentations
              Liquid Phase Synthesis of Oligonucleotides
              • Andrew Livingston - Professor of Chemical Engineering, Imperial College London
              On Demand - Premium Only
              On-Demand Presentations
              Advances in the Chromatographic Purification of Oligonucleotides
              • Andrew Rodriguez, PhD - Assistant Director, Process Chemistry, Ionis Pharmaceuticals
              On Demand - Premium Only
              On-Demand Presentations
              Control of Impurities and Overall Purity in GalNAc siRNA Conjugates
              • John Richards, Ph.D. - Global Drug Development/Technical Research & Development, Novartis
              On Demand - Premium Only
              On-Demand Presentations
              QBD and DoE Approaches to Oligos – Applications for Process Robustness
              • Thomas Emery - Associate Scientist, GSK
              On Demand - Premium Only
              On-Demand Presentations
              Early Phase CMC and Regulatory Strategy for Oligonucleotides
              • Marc Lemaître, PhD - Chief Operating Officer / Principal, Sirnaomics, Inc. / ML Consult
              On Demand - Premium Only
              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
              On Demand - Premium Only
              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
              On Demand - Premium Only
              On-Demand Presentations
              “Points-to-Consider” When Planning Your First Oligonucleotide Drug Product Campaign
              • Stefan Vonhoff, Ph.D. - Vice President CMC, NOXXON Pharma AG
              On Demand - Premium Only
              On-Demand Presentations
              Terminal Sterilisation of Oligonucleotide Drug Products
              • Nadim Akhtar, PhD - Principal Scientist, AstraZeneca
              NextOligonucleotide Discovery
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