Resources
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Qualification and Validation of MS Methods 2020
Roundtable 1 Notes: Mass Spec 2020
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Application of Mass Spectrometery for AAV-based Gene Therapy Analysis
Speaker Presentation Pu Yi, Biogen, 2020
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Building a Sensitive MS-Based Proteomic Approach to Better Characterize CAR-T Cell Therapies
Speaker Presentation Lombard-Banek Camille, National Institute of Standards and Technology (NIST), 2020
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The Impact of Immunoglobulin G1 Fc Sialylation on Backbone Amide H/D Exchange
Speaker Presentation Kuhne Felix, Roche Diagnostics GmbH, 2020
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Multiplexing the Orbitrap to Readout Individual Ion Mass Spectra of Virus-Like Particles
Speaker Presentation Kelleher Neil, Northwestern University, 2020
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Spontaneous Modifications in Long-Lived Proteins: Structural and Biologial Implications
Speaker Presentation Julian Ryan, University of California, Riverside, 2020
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HCP Profiling and Prediction of Polysorbate Stability in mAb Formulation
Speaker Presentation Huang Lihua, Eli Lilly and Company, 2020
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Implementation of MAM for Quality Control of Monoclonal Antibody Therapeutics
Speaker Presentation Hao Zhiqi, Genentech, a Member of the Roche Group, 2020
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A Novel, Rapid Chip-Based iCIEF-MS Analysis of Therapeutic mAb Charge Variants Under Forced Degradation Conditions and Comparison to Traditional Methods
Speaker Presentation Donnelly Daniel, Merck & Co. Inc, 2020
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Advantages of Emergent MS Methods for Analysis of Clinically Relevant Glycans
Speaker Presentation Costello Catherine, Boston University Medical School, 2020
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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