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Well Characterized Biologicals


Innovative Strategies and Regulatory Guidance for Characterizing Biological Products and Identifying and Controlling Variants and Impurities

November 03-04, 2014 · Washington Marriott at Metro Center · Washington, DC

Event Overview

Event Overview

FDA Keynote Speaker Interview Now Available

Hear FDA speaker Dr. Lokesh Bhattacharyya provide insights of his keynote presentation covering the new FDA Draft Guidance on Analytical Procedures and Analytical Method Validation for Drugs and Biologics

Listen to the Podcast with Dr. Lokesh Bhattacharyya:

Or download audio

Ensure Accurate CMC Submissions by:

  • Overcoming regulatory challenges by hearing guidance from FDA, Health Canada, US Pharmacopeia, NIST, NIH and the International Serum Industry Association
  • Achieving greater product characterization and lifecycle management by hearing practical case studies and characterization strategies from industry leaders
  • Accelerating your project performance by hearing in-depth updates on recent characterization projects and emerging analytical technologies
  • Enhancing process and product quality by learning about new testing methods to identify and control variants & impurities

"A great conference that puts the well underrated biological processes on display for interested & engaged industry professionals." - Peter Jordan, SciLucent, LLC

The Industry's Leading Conference to Help You Characterize Biological Products and Identify/Control Variants & Impurities

For nearly two decades, Well Characterized Biologicals has been regarded as a must-attend event to get the latest updates on the most novel bioanalytical methods for sound characterization of biologics, and more recently, to identify and effectively control variants and impurities for optimal processing and product quality.

At Well Characterized Biologicals, you can to interact with regulators and hear their perspectives on guidance for industry and insights on how it is best applied. You will also benefit from compelling case studies that explore new protein characterization and detection methods for variants and impurities.

And with two-days of presentations, many of which are chock full of new data, you will leave prepared with applicable knowledge to meet characterization expectations of increasingly complex modalities, while improve your overall CMC, product and process bottom line.

"Well organized conference, wide variety of topics covered by the speakers." - Suranjana Haldar, Dr. Reddy's Lab Ltd.

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
  • Bioassay Development
  • Regulatory Affairs and QA/QC
  • Process Development
  • Product Development
  • Technical Operations/Manufacturing Sciences
  • Drug Product Manufacturing
  • Clinical Supply Chain Procurement

Attendee Testimonials

"Great conference! I learned a lot and got some great ideas for the development of in-house methods. I thought the FDA presentations were terrific…and put the fear of God in me. Amazing job keeping the conference going in the face of a hurricane" - Jacqueline McGourty, Associate Director, Emergent Biosolutions

"A conference with REAL information that is readily applicable to real issues with biologicals" - Sheila Magil, Senior Consultant, Bioprocess Technology Consultants"

"Even with obstacles from Mother Nature (namely Hurricane Sandy), the conference went on and I had a wonderful experience attending" - Wing-Yee Fu, Associate Scientist, Momenta Pharmaceuticals

"Both the organizers and the presenters did an excellent job - great content, variety and relevance to today's industry needs…despite Hurricane Sandy" - James D. Mendoza, Staff Scientist, Beckman, Coulter, Inc.

"Well organized and balanced conference" - Parag Goyal, Principal Scientist, Dr. Reddy's Lab

"I enjoyed the conference. There was plenty of new knowledge gained from the presentations and new opportunities for networking with colleagues in the industry" - Bridgitte Speights, Director, CMC Regulatory Affairs, Cephalon

"This conference was very relevant with current events and trends. It provided a good arena for industry leaders to network and share ideas and best practices" - John Alvino, Manager, MedImmune

"It's a great conference in the biologics arena" - Shenjiang Yu, Associate Director, Merck & Co.

"A great conference where statistical experts and process SME's meet" - Tom Geyskens, Process Engineer, Genzyme