Biotherapeutics Analytical Summit
Venue: Hyatt Regency, Bethesda, MD USA
Date: 20 - 24 March, 2017
Product Stream Method Development, Qualification & Validation  
Advances in Characterization Methods & Approaches  
Comparability & Biosimilarity  

Process Stream product-process  
Process Analytics & Characterization  

Empowering Innovation with the Right Tools and Techniques

Today's complex biologics formats and ever increasing regulatory demands necessitates that companies come up with the most efficient, accurate and robust analytical methods to characterize a molecule; find the most effective tools to assess the molecule's physico-chemical properties to optimize its druggability and developability, and to ensure that the end product is consistently safe and efficacious when comparing between batches or between biosimilars and innovators. When it comes to batch-to-batch variation, as the saying goes, "process is the product" - process analytics and quality control are thus of biggest concern to manufacturers and regulators alike.

Cambridge Healthtech Institute's Eighth Annual Biotherapeutics Analytical Summit has grown from strength to strength year over year, covering a wide variety of product characterization topics ranging from post-translational modifications to bioassays, from process change to compliance, from developability to biosimilarity. This year, in response to industry demands gathered from extensive research and surveys, we have come up with an expanded programming that reaches both product- and process-characterization topics stated above.

Our 2017 list of NEW and EXPANDED topics includes:

Method Development, Qualification & Validation
Developing Fit-for-Purpose Methods throughout Product Lifecycle

Advances in Characterization Methods & Approaches
Harnessing Technologies to Speed Innovation

Comparability & Biosimilarity
Ensuring Regulatory Compliance and Commercialization Success

Process Analytics & Characterization
Process Understanding, Quality and Control throughout Product Lifecycle

To complement the event and meet the individual needs for more intense, focused training on specific topics, we will also be bringing you a variety of short courses, including

  • Sub-Visible Particles, Aggregates and Impurities: Measurement, Characterization and Impact
  • Glycobiology of Antibodies
  • New Analytical Approaches and Strategies for Comparability & BIosimilarity

*Separate registration required

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by November 11
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"Great talks from academia/university personnel with reviews of the literature."
- Professor, University of Manitoba

"Very intimate setting; insightful presentations. A great way to get perspective of the field!"
- Scientist, Janssen


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