Papers and Presentations
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CMC Strategy Forum Latin America 2023 Summary Infographic
Summary Infographic: CMC Strategy Forum Latin America 2023
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mRNA-launched Nanoparticle Vaccines
Speaker Presentation Carter Lauren University of Washington 2023
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BIONDDTM for Oral Delivery of Biologics –
The Future Delivery of Pharmaceuticals
Speaker Presentation Lindhardt Karsten Biograil 2023
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Stability Predictions for mAbs Using Arrhenius-Based Kinetics
Speaker Presentation Zidar Mitja Novartis Pharma AG 2023
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Collaborative CMC Assessment of Post Approval Change Management Protocols: A Regulatory Health Authority-Perspective
Speaker Presentation Wilson Willie CBER, FDA 2023
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EFPIA Survey of EU Experience on Use of Quality Expedited Access (Including EU PRIME Toolbox) Tools
Speaker Presentation Wilkinson Diane AstraZeneca 2023
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Considerations for Potency Testing of mRNA Products
Speaker Presentation Widomski Pawel BioNTech 2023
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How to Connect Patient Centric Specifications with Immunogenicity of Biotherapeutics - A Regulator’s Perspective
Speaker Presentation Welin Mats Swedish Medical Products Agency 2023
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CMC Regulatory Considerations for Antibody-Drug Conjugates
Speaker Presentation Vriezen Nienke Byondis 2023
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Characterizing and Controlling Modes of Action - Critical Requirements for Potency Assays
Speaker Presentation Tomek Markus AGES, Austria 2023
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EMA Perspectives on International Convergence and Collaboration for CMC Submissions
Speaker Presentation Tiitso Klara European Medicines Agency 2023
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Antibody Drug Conjugates as Specific and Potent Medicinal Products - A Regulator's Perspective
Speaker Presentation Steffen Gross Paul-Ehrlich-Institut 2023
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In vitro Potency Assay for Follitropin alfa: A Case Study of Worldwide (Ongoing) Registration
Speaker Presentation Rochemont Morgane Merck & Co., Inc. 2023
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Leveraging Prior Knowledge to Support Early Phase Clinical Trial Applications: Regulatory CMC Considerations and Case Studies
Speaker Presentation Roberts Scott Novo Nordisk A/S 2023
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Advanced Kinetic Modelling - A Universal Tool for Stability Predictions of Biotherapeutics and Vaccines
Speaker Presentation Reddington Colm AstraZeneca 2023
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Advanced Kinetic Modelling: A Universal Tool for Stability Predictions of Biotherapeutics and Vaccines
Speaker Presentation Ramesh Sreejith Sanofi 2023
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In vitro Assessments of Immunogenicity
Speaker Presentation Morgan Hanna Novartis Pharma AG 2023
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Collaborative Approaches ICMRA Pilot on Collaborative Assessment of Post-Approval Change: Applicant's Experience
Speaker Presentation Meillerais Sylvie Merck Sharp & Dohme B.V. 2023
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Welcome & Introduction to the EFPIA Manufacturing and Quality Expert Group (MQEG) -Biomanufacturing Satellite Session
Speaker Presentation Goese Markus F. Hoffmann-La Roche Ltd. 2023
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Best Practices for Design and Performance of In-Use Stability and Compatibility Studies
Speaker Presentation Fast Jonas F. Hoffmann-La Roche Ltd. and Liu Jing Seagen Inc. 2023
CASSS On Demand
Access approved content from past meetings in the NEW CASSS On Demand platform. CASSS members have access to all available presentation recordings starting in April 2020. Visit https://ondemand.casss.org, login to your account, and select from the list of meetings to begin.