November 3 - 4, 2016
The Westin Arlington Gateway,
Ensure CMC Success Through Novel Characterization Strategies and Regulatory Guidance
The leading case study-driven conference for understanding today's characterization strategies and regulatory guidelines to accelerate biologic and biosimilar approval
Well Characterized Biologicals is the industry's most trusted and longest running event to gain the regulatory guidance and analytical characterization strategies you need to ensure accurate CMC submissions.
Timely & Data-Driven Strategies
Overcome roadblocks in the path to commercialization by hearing up-to-date case studies and new data on promising cell-based products in clinical and commercial development.
Comprehensive Regulatory Guidance
Gain solutions to your current challenges and ensure accurate CMC submissions by hearing comprehensive regulatory updates from 8+ regulators representing CBER, CDER, NIH, NIST, and U.S. Pharmacopeia.
Accelerate Biosimilar Development
Develop the next blockbuster therapeutic by understanding how to demonstrate comparability, extrapolation of indications, and interchangeability in your biosimilar.
Achieve Robust Characterization
Hear 30+ new data and case studies from industry leaders on recent characterization projects that utilized the latest high throughput screening methods, characterization strategies, analytical technologies, and more.
Hear directly from the experts on novel characterization strategies
Learn about today's strategies for commercial success and how to avoid common pitfalls in your analytical and CMC studies from thought-leaders in the industry.
New and Exclusive Content for 2016
Improve your analytical tool kit with new content, critical regulatory updates, and collaborative session formats.
Bioassay Development Strategies and Applications
Hear from Genentech, KBI Biopharma, FDA, Shire, and more on novel analytical tools, methods, and characterization strategies to accelerate Bioassay development and approval.
4 Exclusive Technology Workshops
Dive deep into informative and interactive workshops led by Bruker Daltonics, Inc., Unchained Labs, and ThermoFisher Scientific as they share novel research and evaluation in biologics.
Featured Presentation from U.S. Pharmacopeia
Hear directly from Director Maura C. Kibbey Ph.D. as she discusses the newly proposed Physical Reference Standards for Measurement and Characterization of Impurities.
Present a poster in the Poster and Exhibit Hall and derive more value from attending
Share your novel research with your peers and learn from other posters as well.
The deadline to submit an abstract and be included in the conference documentation is Friday, October 14, 2016 (full payment for conference and poster fee must be received by this date). After that date, posters are on a space-available basis.
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.
Luncheon Roundtable Discussions
Taking place during the networking luncheon each day, our 10+ roundtable discussions are your chance to take a break from PowerPoint slides to discuss challenges, roadblocks, and solutions to the biggest issues in characterization, immunogenicity, and biosimilars in an interactive setting.
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.
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.
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
- Bioassay Development
- Regulatory Affairs and QA/QC
- Process Development
- Product Development
- Technical Operations/Manufacturing Sciences
- Drug Product Manufacturing
- Clinical Supply Chain Procurement