Advances in Characterization Methods and Approaches


With newer and more complex molecules taking the spotlight these days, companies need better and faster ways to characterize these non-traditional antibodies. These new entities, coming in the different flavors of bispecifics, conjugates, multi-components, combinations, fusions etc., do not work well with the existing platforms. Coupled with the massive amount of data coming out from mass spectrometry and the regulatory demands for more accurate particle analysis and immunogenicity risk assessment, the industry is eager for novel approaches, proven methods and creative strategies that can help them analyze, interpret and translate information into innovation.

The Advances in Characterization Methods and Approaches conference arms scientists with the tools to develop the right strategies to speed up innovation, such as using simulation and modeling for aggregate prediction and risk assessment; adapting existing platforms/methods to newer products; developing high throughput techniques for multi-parameter analysis; using design space and real-time release testing to improve CMC process, as well as improved methods for better understanding of the molecule’s structure-function dynamics, charge heterogeneity, post-translational modifications, and sequence variants.

We are currently inviting presentation proposals on the following preliminary topics: 

  • Platformization / Platform Assays
    • Standardization for more efficient development, especially for non-mAbs and emerging formats
  • Multi-Parameter Analytics/Multi-Attribute Characterization
  • Simulation and Modeling
    • Modeling changes in sequencing and understanding aggregation moa
  • Automation
  • Real-time Release/In-process Release Testing
    • Online, at-line, in-line process control and monitoring –faster processing and faster release
  • Particle Analysis – Size, Count, Identification and Characterization
    • Mitigate, classify and characterize visible, subvisible and submicron particles
  • Characterization Strategies for Novel and Emerging Biotherapeutics
    • Bispecifics, ADCs, Cytokine Fusion Proteins, Multi-component Molecules, Combination Products etc.
    • Quantitating homodimers in bispecifics
    • Post-translational modifications in fusion proteins and ADCs
    • How to Adapt/Apply Existing Technologies/Methods to Novel Products?
  • Characterization Strategies to Support Breakthrough Therapies
    • Use of design space to improve characterization and CMC process
    • Challenge of compressed timelines and strategies to speed up the CMC process
  • Lifecycle Management of Analytical Assays
  • New and unique Case Studies on Heterogeneity, Protein Structure & Dynamics, PTMs, Glycosylation and Sequence Variants for Existing and New Biomolecules

Please click here to submit a speaking proposal for review.

Deadline for submission: August 7, 2015 

All proposals are subject to review by the Scientific Advisory Committee to ensure the overall quality of the conference program. Please note that due to limited speaking slots, preference will be given to abstracts from those within pharmaceutical and biopharmaceutical companies, regulators and those from academic centers. Additionally, as per CHI policy, a select number of vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships. 

For questions about the meeting, please contact:
Mimi Langley
Sr. Conference Director
Cambridge Healthtech Institute
Phone: 816-472-0701
Email: mlangley@healthtech.com 

For partnering & sponsorship information, please contact:
Jon Stroup
Sr. Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-5483
Email: jstroup@healthtech.com