Method Development Qualification & Validation (Part of Biotherapeutics Analytical Summit)

The Method Development Qualification & Validation (Part of Biotherapeutics Analytical Summit) covers topics such as:

  • MAM Method Development and Qualification
  • Regulatory Perspectives on Analytical Method Validation and Transfer for Biopharmaceutical ProductsSubvisible Particle Analysis: New Tools and Potential Opportunities
  • Development and Implementation of High-Throughput Assays to Support Process Development
  • Analytical Method Replacement Strategies and Case Studies for Late-Stage Development and Approved Products
  • Developing an Analytical Platform for an Accelerated Vaccine Program
  • ADC Method Development and Validation Strategies
  • Development and Qualification of an Activity Assay Using a Physiologically Relevant Substrate
  • Application of Design of Experiment (DOE) in Analytical Method Development
  • The Impact of Excess Antigen and Non-Linearity of Dilution on Host Cell Protein Immunoassay Development and Qualification
  • Development and Qualification of a Novel Cell-Based Assay for Therapeutic mAb against Viral Infection

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

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