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
*Separate registration required
"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