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Well Characterized Biologics & Biological Assays

November 11, 2019 - November 13, 2019

The Well Characterized Biologics & Biological Assays meeting provides the regulatory guidance and analytical characterization strategies you need to ensure accurate CMC submissions. Attend November 11-13 in Reston, Virginia, to cross-fertilize ideas and discuss common challenges with CMC, analytical, and biological assay colleagues. You will also get the chance to hear directly from the FDA and regulatory speakers to get all your questions answered.

The program consists of two tracks:

  • Well Characterized Biologicals Track
    • Characterization strategies and Analytical Methods for Bispecifics, Fusion Proteins & New Modalities like Cell and Gene Therapies
    • Meet FDA speakers: Learn about common pitfalls & how to expedite your programs
    • Discuss ways to Accelerate Method Preparation to Expedite Timelines
    • Hear about Glycan Method Analysis and Case Studies
    • Discuss CMC Package Comparability Studies – Traditional vs. New Modalities
    • Learn about Novel Technologies Emerging Trends in Analysis of Biologics from CES-MS to HDX to NMR and more
  • Biological Assays Track
    • Learn how to accelerate timelines for assay development
    • Build Robust Bioassays which can cope with Analytical Method Transfer between Research and QC Environments
    • Case studies around tried and tested technology approaches for bioassay optimization
    • Overcome challenges with In House Bioassays and Critical Reagent variability
    • Case studies for the latest assay developments for novel and complex molecules

Register now using code PM360 to receive 10% off.

Details

Start:
November 11, 2019
End:
November 13, 2019
Event Category:
Website:
https://lifesciences.knect365.com/well-characterized-biologicals/?vip_code=PM360&utm_source=PM360&utm_medium=Newsletter

Organizer

knect365
Email
register@knect365.com

Venue

Hyatt Regency Reston
Reston, Virginia + Google Map