Resources
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Structure, Heterogeneity and Developability Assessment of Therapeutic Antibodies
Speaker Presentation Beck Alain, Pierre Fabre Laboratories, 2020
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Direct Quantitation of Therapeutic Antibodies for Pharmacokinetic Studies using Immuno-Purification and Intact Mass Analysis
Speaker Presentation Bateman Kevin, Merck & Co. Inc, 2020
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The Expanding Hyphenation of LC Techniques to MS for Intact Mass Characterization of Biopharmaceuticals During Development - Lessons Learned and The Road Ahead
Speaker Presentation Bach Kristensen Dan, Symphogen, 2020
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Past, Present, and Future State of Mycoplasma Testing
Speaker Presentation Tai Kenneth, Kite, a Gilead Company, 2021
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Global CMC Convergence: an FDA Perspective
Speaker Presentation Schultz Kimberly, CBER, FDA, 2021
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Potency Assay Development Cell-based Therapy for Cartilage Repair
Speaker Presentation Roël Giulietta, CO.DON AG, 2021
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Product Structural Characterization for AAV-based Gene Therapy Development
Speaker Presentation Pu Yi, Biogen, 2021
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Autologous Cell Therapy Phase Appropriate Control Strategies from Early Clinical Development to Commercialization
Speaker Presentation Polson Nolan, Bristol-Myers Squibb Company, 2021
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Facilitating Advanced Technologies in Cell and Gene Therapies
Speaker Presentation Oh Steven, CBER, FDA, 2021
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BLA Post-Approval Case Studies for Oncolutic Virus, IMYGIC® (TALIMONGENE LAHERPAREPVEC)
Speaker Presentation McQueen Jocelyn, Amgen Inc., 2021
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Singapore’s New Cell, Tissue and Gene Therapy Products Regulations
Speaker Presentation Kellathur Srinivasan, Health Sciences Authority, 2021
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Regulation of Cell and Gene Therapies in Australia
Speaker Presentation Hislop Andrew, Therapuetic Goods Administration, 2021
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Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (BGTC)
Speaker Presentation Hoffman Steve, The Foundation for the National Institutes of Health, 2021
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Overcoming the Challenges Getting ATMPs Approved in the European Union
Speaker Presentation Celis Patrick, European Medicines Agency (EMA), 2021
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Emergence and Advancement of Technologies: Regulatory Challenges and Considerations
Speaker Presentation Haile Yohannes, Health Canada, 2021
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ATMPs in the UK: Routes to Market and Avoiding “Trees on the Track”
Speaker Presentation Bisset Louise, MHRA- Medicines and Healthcare Products Regulatory Agency, 2021
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Trending MS Topic via Attendee Polling - Analytical Mass Spectrometry Challenges with New Modalities
Roundtable 12 Notes: Mass Spec 2021
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mRNA Characterization by MS – What Are the PQAs and What Are the Methods
Roundtable 11 Notes: Mass Spec 2021
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Successful Implementation of Top/middle Down MSMS for Characterization
Roundtable 10 Notes: Mass Spec 2021
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Best Practices for Reporting MS Data in Regulatory Filings
Roundtable 9 Notes: Mass Spec 2021