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October 24-26, 2018
Hilton Washington DC/Rockville Hotel & Executive Meeting Center,
Rockville, MD

Ensure CMC Success and Expedite Your Product’s Path to Market by Optimizing Characterization Strategies and CMC Bioassay Development

Gain Practical Advice From Case Studies, Regulatory Interactions And Perspectives, And Emerging Technologies To Accelerate Your Biologics Programs

Cross-Fertilize Ideas and Discuss Common Challenges with CMC, Analytical, and Biological Assay Colleagues

Track 1: Modality Specific Characterization & Strategies for Diverse Products
  • Analytical Methods for ADCs, Bispecifics and Fusion Proteins
  • New Modalities
  • Protein Characterization & Product Comparability
  • Biosimilar Comparability & Interchangeability
  • Stability Studies
  • Specification Setting
Track 2: Areas & Applications of Characterization
  • Host Cell Proteins
  • Process and Product Variants and Impurities
  • Higher Order Structure
  • Upstream and PAT
  • Breakthrough Therapy Designation
  • Immunogenicity
Track 3: Improving Biological Assay Development and Validation for Platform and Emerging Modalities
  • Are the Guidelines Aspirational?
  • Lifecycle Approaches and Strategies for Bioassay Development
  • Applying DOE and QbD to Bioassay Development
  • Developing Bioassays for Biosimilars 
  • Bioassay Development for Complex Molecules & Cell Therapies
  • Monitoring Performance, Controls, and Reference Management Programs for Bioassays
  • CMC Biological Assay Case Studies
  • Potency Assays – Automation, Statistics, and Critical Reagents

More attendees, additional speakers, more posters, extra networking!

Learn about regulatory expectations from the source by meeting with multiple FDA reviewers
  • FDA Town Hall with Alfred Del Grosso & Lokesh Bhattacharyya from CBER
    • You’ll have the opportunity to ask your burning regulatory questions directly to the regulators in an engaging town hall format! More regulators to be announced soon!

  • FDA Keynotes Presentations
    • Lokesh Bhattacharyya -CBER
    • Alfred Del Grosso - CBER
    • Arulvathani Arudchandran - CDER
    • Wojciech Jankowski - CBER
Networking events to round out the learning experience
  • Luncheon roundtables: No PowerPoint slides here! Join interactive discussions around your challenges, roadblocks, ideas, and solutions to the biggest issues in characterization and bioassay development.
  • Poster and Exhibit Hall: Drive your development and manufacturing efforts forward by meeting the experts behind today’s leading technologies and products in the poster and exhibit hall!
  • Multiple networking breaks and seated luncheons, an evening reception in the exhibit hall, and an event app!
3 Pre-Conference Workshops
  • Technology for Analytical Characterization: Formulation and Common Challenges
    • HDX-MS
    • Advancing CE-SDS Technology
    • IM-MS for Characterization of Charge Variants and more!

  • Statistical Analysis, Views and Practical Concepts to Build Understanding and Improve Biological Assay Development - A Modular Approach

  • Taking it to Another Level: Phase Appropriate Validation of Bioassays

Present a Scientific Poster


Highlight your company's latest research findings by presenting a scientific poster, which will be displayed in the Exhibit & Poster Hall during the event. The deadline to submit your poster is Friday, October 5, 2018.

Be an Industry Insider


Get the exclusive Whitepaper on Cell and Gene Therapy: What are the analytical challenges and most relevant bioassays?

“The single biggest hurdle faced in cell and gene therapy commercialization is technical. The manufacture of biologics, relies on living systems, which adds a layer of complexity that is absent from other therapies. The number of cell types applicable to cell therapy is vast and their characteristics are easily influenced by the environment. This makes defining and testing the quality of cell therapy manufacturing challenging.

Collaboration could be critical for overcoming technical challenges in the industry.”

Who Should Attend?


Send a team to capitalize on this unique opportunity to meet face-to-face with multiple regulators. Benefit from hearing unpublished data that will only be shared in person at this meeting. The practical advice and industry case studies at this event will benefit Scientists, Technicians, Managers, Lab Heads, Directors and other specialists in the following departments:

  • Analytical R&D     
  • CMC     
  • Protein Analytical Chemistry     
  • Biological Assays      
  • Bioassay Development and Innovation     
  • Regulatory Affairs and QA/QC     
  • Process Development     
  • Product Development     
  • Technical Operations/Manufacturing Sciences     
  • Drug Product Manufacturing     
  • Clinical Supply Chain Procurement     
  • Bioanalytics     
  • Biological Development and Technologies     
  • Statistics     
  • Characterization

WCB Numbers Stack Up

70+
Speakers
200+
Scientists and Executives
3
Unique Tracks
2
Pre-Conference Workshops
10+
Luncheon Roundtable Discussions
15+
Solution Providers

Venue

Hilton Washington DC/Rockville Hotel & Executive Meeting Center

Venue Address:

1750 Rockville Pike

Rockville, MD 20852 

Phone: (301) 468-1100

Visit the Hotel Website