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October 25-28, 2021
Delivered in a 100% Digital Format

We Are Currently Accepting Proposals for Speaker Presentations

To submit a proposal, you will need to select the conference topic you are interested in, indicate whether your presentation will include a CASE STUDY or NEW DATA, provide a 60-90 word summary of your proposed talk, and provide your full contact details. Deadline: April 30, 2018.

We are looking for presentations in the following topic areas:

Well Characterized Biologicals Track

  • Case Studies of Protein Characterization and Product Comparability
  • Characterization Strategies for ADCs, Bispecifics, Fusion Proteins
  • Characterization Strategies and Case Studies for New Modalities (Cell & Gene Therapies etc.)
  • Biosimilar, Biobetter and Interchangeable Characterization and Comparability
  • Analytical Strategies for Host Cell Proteins and Particulates
  • Strategies for Higher Order Structure
  • Control of Product and Process Variants and Impurities
  • Emerging Analytical Technologies and Applications (including mass spec and other technologies and the interface between mass spec and other equipment)
  • Regulatory Perspectives on Common Pitfalls in Your Analytical and CMC Studies
  • Comparability Strategies across the Product Lifecycle
  • New Developments for the Multi-Attribute Method
  • Methods for Particle Characterization
  • Characterization Case Studies of Vaccines, Combination Products, Complex Molecules

Biological Assays Track

  • CMC Biological Assay Case Studies
  • Automation of Bioassays
  • Use of DoE Approaches in Bioassay Development
  • Method Lifecycle Development for Bioassays
  • Method Bridging and Method Tech Transfer for Bioassays
  • QbD and Continuous Method Verification for Bioassays
  • How to Maintain a State of Method Control for Legacy Bioassays
  • Monitoring Stability of Reference Standards for Potency Assays
  • Bioassay Development for Biosimilars
  • Bioassays for ADCs, Bispecifics, Cell Therapies and DNA/RNA Therapeutics
  •  Statistical Approaches for Biological Assays