October 24-26, 2018
Hilton Washington DC/Rockville Hotel & Executive Meeting Center,
Ensure CMC Success and Expedite Your Product’s Path to Market by Optimizing Protein Characterization Strategies and CMC Bioassay Development
Gain Practical Advice from Numerous Case Studies, Regulatory Perspectives, and Technology Applications to Accelerate Your Own Biologics Programs
Cross-Fertilize Ideas and Discuss Common Challenges with CMC Analytical Colleagues
Each track features case studies with practical advice you can apply in your CMC programs and new data and lessons learned all within an open information-sharing environment.
Well Characterized Biologicals Track
- Regulatory Perspectives on Common Pitfalls in Your Analytical and CMC Studies
- Analytical Characterization Strategies for ADCs, Bispecifics, and Fusion Proteins
- Case Studies of Protein Characterization and Product Comparability
- Biosimilar Characterization and Comparability
- Analytical Methods for Identification and Quantification of Host Cell Proteins
- Strategies for Higher Order Structure
- Methods for Identifying, Monitoring and Controlling Product and Process Variants and Impurities
- Strategies for Stability Studies for Diverse Products
Biological Assays Track
- QbD and DoE Approaches to Bioassay Development
- Lifecycle Management of Bioassays and Assay Changes to Commercial Products
- CMC Biological Assay Case Studies
- Bioassay Development for Biosimilars and Complex Molecules
- Method Bridging and Method Tech Transfer for Bioassays
- Potency Assays: Automation, Statistics & Critical Reagents
- Regulatory Perspectives on Method Lifecycle Development for Bioassays
Learn about Regulatory Expectations Straight from the FDA from the Physiochemical and Functional Perspective
New for 2017! Two In-Depth Pre-Conference Workshops
These two full-day workshops give you an extra day to round out your learning and networking.
An Introduction to Bioassay Development
This workshops focuses on the role of Bioassays in the CMC process and product characterization lifecycle and covers topics including:
- Strategies for the design, development, and validation of biological assays for a variety of different molecules, including complex, non-platform modalities.
- The role of automation, new technologies, and statistics in the bioassay development and validation process.
- Latest regulatory expectations and steps you can take to ensure your biological assay will meet the ever-higher industry standards.
Mass Spectrometry and Other Analytical Technology to Enable Protein and Molecule Characterization
This multi-speaker workshop will begin with an introduction to an array of analytical technologies currently used. Attendees will then hear a diverse range of case studies and unpublished data discussing these relevant and useful analytical technologies for characterization.
Topics covered include:
- Using QC Friendly Mass Spectrometry to Quantitate the Critical Charge Variant from a Minor Component in Combination
- Applications of 2D NMR for Characterization of Monoclonal Anitbody Therapeutics
- Mass Spec for Potency Testing of Adenovirus Vectors
- Analytical Technologies for Formulation Development and Characterization of Proteins and Molecules
Unsurpassed Networking Opportunities
Gain a competitive advantage by meeting face-to-face with the right partners and investors who can fund, license, and manufacture your promising therapeutic.
10+ Luncheon Roundtable Discussions
No PowerPoint slides here! Join interactive discussions around your challenges, roadblocks, ideas, and solutions to the biggest issues in characterization, bioassay development, immunogenicity, and biosimilars.
Poster and Exhibit Hall
Drive your development and manufacturing efforts forward by meeting the experts behind today’s leading technologies and products at the most comprehensive and relevant exhibit hall.
This year the exhibit hall is larger than ever and will feature the latest analytical and bioassay technologies and services.
Taking place in the exhibit hall, the Networking Reception is the place to meet, connect, and establish new relationships with the 200+ scientists and executives that attend year after year.
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, September 28, 2018.
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
- 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
- Biological Development and Technologies