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Oligonucleotide CMC
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Characterization of the Diastereoisomeric Composition of Phosphorothioate Oligonucleotides
- Claus Rentel, PhD-Executive Director, Analytical Development/QC,Ionis Pharmaceuticals, Inc.
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WHITEPAPER: From Research to Commercial Quantities: A Seamless Supply of Oligonucleotides
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Boosting Commercialization of Oligonucleotides as a Raw Materials Supplier with Aldevron
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Large Scale Manufacturing for Oligonucleotide API
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CASE STUDY: Scaling Up Manufacturing When it’s Needed Most
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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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WHITEPAPER: Oligonucleotide Purification and Analysis: A Chromatography Overview
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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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WHITEPAPER: Oligonucleotide API Manufacturing and CMC Services
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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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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,葛兰素史克公司
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Doing an IND with An NDA in Mind: Planning for Regulatory Interactions
- Jennifer Franklin-导演,CMC监管事务,Ionis Pharmaceuticals
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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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Accelerated Stability Assessment of Oligonucleotides
- Mark Madsen, PhD-Assistant Director, Analytical Development & Quality Control,Ionis Pharmaceuticals
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From Amidites to Drug Product: Quality Control Analysis of Oligonucleotide Therapeutics
- Carolyn Mazzitelli-Associate Director,Ionis Pharmaceuticals
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Phase Appropriate Analytical Control Strategies for Oligonucleotides
- Jessica Stolee, PhD-Associate Director, Pharma and ASO Analytical Deve,Biogen
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概述啊f Current Technical Challenges in Oligonucleotide CMC
- Marc Lemaître, PhD-Chief Operating Officer / Principal,Sirnaomics, Inc. / ML Consult
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Liquid Phase Synthesis of Oligonucleotides
- Andrew Livingston-Professor of Chemical Engineering,Imperial College London
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Advances in the Chromatographic Purification of Oligonucleotides
- Andrew Rodriguez, PhD-Assistant Director, Process Chemistry,Ionis Pharmaceuticals
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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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QBD and DoE Approaches to Oligos – Applications for Process Robustness
- Thomas Emery-Associate Scientist,GSK
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Early Phase CMC and Regulatory Strategy for Oligonucleotides
- Marc Lemaître, PhD-Chief Operating Officer / Principal,Sirnaomics, Inc. / ML Consult
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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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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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“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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Terminal Sterilisation of Oligonucleotide Drug Products
- Angela Wagner, PhD-Associate Principal Scientist, Sterile & Specialty,Merck Sharpe & Dohme
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