Resources
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Regulatory Considerations for the Application of Multi-Attribute Methods by Mass Spectrometry for QC Release and Stability Testing of Biopharmaceuticals
Speaker Presentation Gervais Annick UCB_EFPIA 2022
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A Roadmap to Get Host Cells Proteins Analysis by Mass Spectrometry in a GMP Environment
Speaker Presentation Chéry Cyrille UCB 2022
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Enhanced Process Characterization Study with Monte-Carlo Simulation
Speaker Presentation Broly Hervé Merck Serrano 2022
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Support to Innovation by EMA - Facilitating Translation of Technology into Medicinal Products
Speaker Presentation Bream Robert EMA 2022
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Establishing Platform Technology Master Files for Human Medicinal Products in the EU/EEA
Speaker Presentation Bilanin Mihai GSK 2022
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Agile Manufacturing -Transfer and Scale-up of Biologics Aseptic Manufacturing Processes through Control Site Concept
Speaker Presentation Bechtold-Peters Karoline Novartis Pharma AG 2022
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Immunogenicity or Not of Biologics in the Subcutaneous Space
Speaker Presentation Balu-Iyer Sathy SUNY, Univeristy of Buffalo 2022
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Industry Proposal For The Use Of QBD And ICH Q12 Principles To Enable Second Sourcing Of Raw Materials
Speaker Presentation Aiyer Kavita Seagen Inc. 2022
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The Power of Data Exchange, CMC Interoperability and a Cloud-based Ecosystem
Speaker Presentation Abernathy Michael Amgen Inc Accumulus Synergy 2022
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A-Mab: A Case Study in Bioprocess Development Study Guide
Case Study CMC-Biotech Working Group 2009
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A-Mab: A Case Study in Bioprocess Development
Case Study CMC-Biotech Working Group 2009
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CMC Strategy Forum Europe 2022 Summary Infographic
Summary Infographic: CMC Strategy Forum Europe 2022
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MAM: Multi-Artifacts Monitoring Operators, Processes and Modalities
Speaker Presentation Zhou Sunny Northeastern University 2022
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Performance Characteristics of Mass Spectrometry-Based Methods for Quantitation of Nitrosamines: Insight from an Inter-laboratory Study
Speaker Presentation Yang Jingyue (Jan) CDER, FDA 2022
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Variable Temperature Native Mass Spectrometry for Studying Thermodynamics of Protein-Ligand Interactions.
Speaker Presentation Walker Thomas Texas A&M University 2022
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Direct Analysis of Heterogeneous Biotherapeutics
Speaker Presentation Sandoval Wendy Thermo Fisher Scientific 2022
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Recent Advances in Oligo Purity and Sequence Determinations by LCMS: Maximizing Throughput, Confidence, and Coverage
Speaker Presentation Rye Peter Agilent 2022
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Unlocking Analytics for AAV Gene Therapy Programs: Leveraging Standard Biotherapeutic Strategies to Transform New Modalities
Speaker Presentation Powers Thomas Pfizer, Inc. 2022
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Development of Automated Workflows for Analysis and Reporting of Peptide Mapping Data
Speaker Presentation Pettit Michael Janssen 2022
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Application of Free Cysteine Footprinting by Differential Alkylation in BioProcess Development
Speaker Presentation Liu Roger Bristol-Myers Squibb Company 2022