Cambridge Healthtech Institute’s Seventh Annual

Rapid Methods to Assess Quality & Stability of Biologics

Improving and Accelerating Prediction and Screening 

August 12-13, 2019

The seventh 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 We are seeking case studies, unpublished work on new methods and tools employed in real time, and accelerated stability studies for proteins, cell and gene therapy products, high-throughput analytics,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 QbB and immunogenicity.

Topics will include, but are 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)

If you would like to submit a proposal to give a presentation at this meeting, please click here.

The deadline for priority consideration is February 11, 2019.

All proposals are subject to review by session chairmen and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

For more details on the conference, please contact:
Nandini Kashyap
Conference Director
Cambridge Healthtech Institute
Phone: 781-972-5406

For partnering and sponsorship information, please contact:

Companies A-K
Sherry Johnson
Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-1359  

Companies L-Z
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-5412