If you are working in any of the following scientific/business topic areas, we encourage you to submit a proposal for a podium presentation. We are especially looking for case studies with new data on the following:
Well Characterized Biologics Track
- Emerging Concepts in Characterization of Biosimilars
- Characterization Strategies and Case Studies for Novel Modalities
- Analytical Strategies, CMC Approaches, and Analytical Tools for Modern Vaccines and Well Characterized Gene Therapies
- Total Analytical Control Strategies
- Innovative Comparability Studies & Strategies Across the Product Lifecycle
- Control of Product and Process Variants and Impurities
- Discussion of Analytical Method Preparation for Early Stage vs. Late Stage
- Accelerating Method Preparation to speed up development timelines
- Emerging Analytical Technologies and Applications (coupling of Mass Spec with other tech)
- Regulatory Perspectives on Common Pitfalls in Your Analytical and CMC Studies
- Regulatory Perspectives on Endotoxin Studies
- Novel Structure/Function Case Studies
- Data Management and Analysis for Analytical Method and Bioassay Development
- Case Studies of Protein Characterization and Product Comparability
- Analytical Strategies for Host Cell Proteins and Particulates
- Novel Methods for Particle Characterization
- Strategies for Higher Order Structure
Biological Assays Track
- Bioassays for ADCs, Bispecifics, Cell Therapies, DNA/RNA Therapeutics, Vaccines and Gene Therapies
- Bioassay Bridging and Correlation Studies
- Case Studies on Potency Assays – Novel Approaches
- 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
- Statistical Approaches for Biological Assays
- Case Studies on Cell Based Therapies for Complex & High Potency Drugs
- Critical Reagent Management
Submit a Proposal
Poster Hall Hours
Tuesday, May 10, 2016
3:00 pm - 6:30 pm
Wednesday, May 11, 2016
10:00 am - 6:30 pm
Thursday, May 12, 2016
10:30 am - 2:00 pm
Presentations should be free of commercial bias as well as any references to commercial products and services. All selected faculty are required to disclose the existence of any significant financial interest. Financial interest may affect the consideration of your presentation/proposal application.
You will be notified by the Event Review Committee if your presentation has been selected.
September 18-21,2023
Boston Convention and Exhibition Center
November 1-3, 2022
College Park Marriott Hotel & Conference Center
Hyattsville, Maryland, USA
Call for Speakers
Deadline to Submit: March 24, 2022
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