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PlenShop Comparability Example: Late Stage Implementation of Major Process Changes
Speaker Presentation Workshop Comparability: Technical Challenges and Regulatory Considerations 2024 -
Sharing Best CMC Practices Based On Advanced Scientific Understanding
Speaker Presentation Workshop Antibody-Drug Conjugates: Sharing Best CMC Practices Based On Advanced Scientific Understanding 2024
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USP® and ATCC® Resources that Support Monitoring of Impurities in Biologics
Speaker Presentation Technical Seminar Presented by US Pharmacopeia 2024
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Current Role of MS in Cell Line Development of Biotherapeutics
Speaker Presentation Technical Seminar Presented by Thermo Fisher Scientific 2024
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Characterization of Complex cIEF Electropherograms from mAb and Antibody-Drug Conjugate (ADC) Using a Novel icIEF-UV/MS System
Speaker Presentation Technical Seminar Presented by SCIEX 2024
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New Technologies for Rapid Characterization of Biologics: From R&D to Manufacturing
Speaker Presentation Technical Seminar Presented by Refeyn Inc. 2024
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Automating Cell-Based Assays: Reducing Variability & Time to Results
Speaker Presentation Technical Seminar Presented by Catalent Pharma Solutions 2024
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Potency Assays for ATMPs – Selection of Assay Platforms and Data Processing Methods are Key Aspects for Successful Control Strategies
Speaker Presentation Technical Seminar Presented by BioAgilytix Labs, LLC 2024
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Untangling the Complexity within Oligonucleotide Therapeutics
Speaker Presentation Technical Seminar Presented by Agilent Technologies 2024
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Microchip CE-MS for Rapid, Deep and Sensitive Analysis of Biopharmaceuticals
Speaker Presentation Technical Seminar Presented by 908 Devices 2024
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Experiences with Implementing ICH Q12 ECs and PLCM
Speaker Presentation Stangler Thomas Sandoz GmbH 2024
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The Visual Inspection Regulatory and Compendial Environment: Current Issues and Opportunities
Speaker Presentation Shabushnig John G. Insight Pharma Consulting, LLC 2024
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Accelerating Biopharmaceutical Development: Data-Driven Strategies, Platforms, and Technologies
Speaker Presentation Rathore Nitin Amgen Inc. 2024
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Drug Delivery Innovations for CEPI’s 100 Days Mission
Speaker Presentation Patel Dimki CEPI 2024
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An Industry Perspective on the Use of Forced Degradation Studies to Assess Comparability of Biopharmaceuticals
Speaker Presentation Nowinski Ann (Kasia) Pfizer, Inc. 2024
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From Blur to Clarity: Definition of Particle VisibilityThreshold in Parenteral Drug Products
Speaker Presentation Nikels Felix Boehringer Ingelheim Pharma GmbH & Co. KG and Koulov Atanas Clear Solutions Laboratories 2024
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A Journey Through the Biopharmaceutical Industry
Speaker Presentation Miller Ken BioMarin Pharmaceutical Inc. 2024
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Building a Comparability Strategy for a Major Post-Approval Manufacturing Change
Speaker Presentation McKnight Nathan Genentech, a Member of the Roche Group 2024
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Considerations for Animal Use and Sustainability
– A Regulatory Perspective
Speaker Presentation Levis Robin CBER, FDA 2024
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Intro to Bayesian and Frequentist Statistics
Speaker Presentation Kirk Jennifer CBER, FDA 2024