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 We are seeking case studies, unpublished work on new methods and tools employed in real time and accelerated stability studies for proteins, cell and gene therapy products, high-throughput analytics,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


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 21, 2020.


All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute’s 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, MPharm
Conference Director
Cambridge Healthtech Institute

Phone: (+1) 781-972-5406


For partnering and sponsorship information, please contact:

Companies A-K
Sherry Johnson
Senior Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-1359

Companies L-Z
Carolyn Cooke
Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-5412

Premier Sponsors: