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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.
Showing 5 of 5 Streams
On-Demand Presentations
Webinars
Whitepapers & Case Studies
Interviews
Scientific Posters
On Demand - For MembersFree
Characterization of the Diastereoisomeric Composition of Phosphorothioate Oligonucleotides
- Claus Rentel, PhD - Executive Director, Analytical Development/QC, Ionis Pharmaceuticals, Inc.
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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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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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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, GlaxoSmithKline
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Doing an IND with An NDA in Mind: Planning for Regulatory Interactions
- Jennifer Franklin - Director, CMC Regulatory Affairs, 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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Overview of 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
- Nadim Akhtar, PhD - Principal Scientist, AstraZeneca
On Demand - For MembersFree
Advancing and Enabling Commercial-Scale Manufacturing of Nucleic Acid Based Medicine
- Anil Kore - Director, Chemistry & Biology, Thermo Fisher Scientific
On Demand - For MembersFree
Oligonucleotide Manufacturing from Small to Large Scale
- Toru Okamatsu - Manager of Business Development, Ajinomoto Bio-Pharma Services
On Demand - For MembersFree
Sample Preparation Strategies for Oligonucleotide Bioanalytical Workflows
- Brian Rivera - Senior Product Manager- Biologics, Phenomenex
On Demand - For MembersFree
New Oligonucleotide GMP Manufacturing Facility from API to Filling & Finishing
- Michael Zhang - Business Development Manager, RiboBio Co.
On Demand - For MembersFree
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 - For MembersFree
Preparative Separation of Oligonucleotide by Ion-Exchange and Hydrophobic Interaction Chromatography
- Oscar (Yosuke) Yamasaki - Product Management Unit, Bioscience Division, Tosoh Corporation
On Demand - For MembersFree
WHITEPAPER: From Research to Commercial Quantities: A Seamless Supply of Oligonucleotides
On Demand - For MembersFree
CASE STUDY: Scaling Up Manufacturing When it’s Needed Most
On Demand - For MembersFree
WHITEPAPER: Oligonucleotide Purification and Analysis: A Chromatography Overview
On Demand - For MembersFree
WHITEPAPER: Oligonucleotide API Manufacturing and CMC Services
On Demand Free
Boosting Commercialization of Oligonucleotides as a Raw Materials Supplier with Aldevron
On Demand - For MembersFree
Oligonucleotides @ Bachem - Interview with Torsten Wöhr
Bachem is expanding its business into the oligonucleotide market. Learn about Bachem’s strategy in entering this competitive market, our advantages, and challenges in the interview with Torsten Wöhr, Head of Oligonucleotides at Bachem.
On Demand - For MembersFree
Large Scale Manufacturing for Oligonucleotide API
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