Cambridge Healthtech Institute’s 8th Annual

Rapid Methods to Assess Quality & Stability of Biologics

Accelerating Prediction and Screening

August 24-25, 2020


The eighth annual Rapid Methods to Assess Quality & Stability of Biologics conference will bring together experts in analytical and formulation development to discuss regulatory expectations, prediction, measurement, and manipulation for protein stability and instabilities in early- and late-stage development. We are seeking case studies, unpublished work on new methods and tools employed in real time and accelerated stability studies for proteins, cell and gene therapy products, high-throughput analytics, multi-attribute methods, biophysicals methods, HOS, use of DOE and QbD, and immunogenicity.


Coverage will include, but is not limited to:


  • Analytical control strategy for early- and late-stage development
  • Prediction and screening of quality and stability in cell and gene therapy products
  • Multi-attribute method (MAM)
  • High-throughput physical and chemical stability screening in early and late stage
  • Role of higher order structure in quality and stability
  • Assessing the comparability and stability of cell and gene therapy products
  • High-throughput analytics for stability testing
  • Automation, rapid in-process parallel monitoring, analysis, and data management
  • Novel predictive techniques and computational modeling tools
  • Detection, characterization, regulatory perspectives, and immunogenicity of aggregates
  • Quality and stability assessment of very low- and very high-concentration protein formulation
  • Rationale study design and effective use of design of experiment (DOE)


* The program is subject to change without notice, due to unforeseen reason.

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