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October 26-28, 2021

THE LEADING EVENT TO ENSURE CMC, REGULATORY SUCCESS AND EXPEDITED PRODUCT APPROVAL

Gain Practical Advice From Case Studies, FDA & Regulatory Leaders to Accelerate Your Biologics & Novel Modalities/Molecules to Market

Accelerate your product timelimes and overcome development and submission challenges


Well Characterized Biologics 2020 Track Highlights
Well Characterized Biologics 2020 Track Highlights
  • Analytical and Biophysical Characterization Requirements for Novel Modalities
  • Characterization and Biophysical requirements for Vaccine Products in an Expedited Environment 
  • Analytical Techniques, Platforms and Strategies for Cell & Gene Therapies
  • Strategies for Accelerated Method Development/High-Throughput and Rapid Analytical Methods/Phase-Appropriate GMP Work
  • Extended and Functional Characterization
  • Implications of Global Pharmacopeial Monographs on Biosimilar Products
  • Analytical Challenges and Considerations for Formulations and Drug Product
Biological Assays 2020 Track Highlights
Biological Assays 2020 Track Highlights
  • Improve how to conduct bioassays for complex drugs such as ADCs, Bispecifics and vaccines
  • Assays for later stages of vaccine production to efficiently get your vaccine approved
  • Streamlining assays for gene therapies
  • Critical Reagent Management – keep a high-quality product
  • Get insight from the scientists at the bench
See What Was New for 2020
See What Was New for 2020
  • Workshop regarding adventitious agent training and TSE filing issues
  • Luncheon Panel Discussion on “What are the challenges when making therapeutics in a COVID-19 setting?”
  • Characterization of vaccines and protein-based therapeutics for COVID-19
  • More speakers and content exploring the unique challenges with analysing cell and gene therapies, including:
    • Streamlining bioassay strategies for MOA
    • Characterization and Comparability
    • Regulatory Requirements
    • Scale up and Manufacturing
  • Additional coverage of the strategies and rapid methods to accelerate development
  • Content on alternate assays beyond traditional assays – insight on improving assays and making them more efficient
  • DoE approaches for bioassays
  • Phase-Appropriate GMP Work
  • Experiences with recently approved therapeutics – Successes, failures and lessons learned
  • New Companies involved this year for the bioassay track include Merck, Sanofi, Zoetis, Janssen

HERE'S SOME NUMBERS FOR YOU...

$2.5B
Is the cost of a typical drug -- Can you afford to be wasting time?
1/10 DRUGS
That enter Phase 1 reach a patient -- Are you staying up-to-date on the latest regulatory guidelines?
50%
of the top 100 drugs by 2021 will be biologics -- how are you preparing to stay ahead of competition?

CONNECT WITH THE INDUSTRY ANYWHERE IN THE WORLD

Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.   

Our virtual event solutions platform allows you to pre-record or live video stream to engage with visitors, answer live Q&A, provide links to related materials, join instant web conferences, and much more. 

Brian Peterson, MSc.

President, Analytical Consulting

Bioassay Solutions LLC

“The Well Characterized Biologics and Biological Assays conference has a long history of attracting scientists and regulatory professionals with a profound interest in developing best practices for analytical strategies. The opportunities to attend talks, focused short courses, and networking sessions, are second only to the experience of discussion and debate with the highest caliber of professionals in the Industry.”