Cambridge Healthtech Institute’s 6th Annual

Rapid Methods to Assess Quality & Stability of Biologics

Improving Prediction and Screening

August 13-14, 2018

Increasing regulatory expectations and aggressive development timelines call for rapid methodologies to predict, assess and assure the quality and stability of biologics throughout the shelf life. The sixth 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 We are seeking case studies, unpublished and innovative work on methods employed in real time and accelerated stability studies for proteins, cell and gene therapy products, high-throughput analytics, multi attribute methods, HOS, use of DOE and QbD and immunogenicity.

Topics covered may include, but are not limited to:

  • Analytical control strategy for early and late-stage development
  • Multi attribute method (MAM) for post-translational modification
  • High-throughput physical and chemical stability screening in early stage discovery
  • 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 for studying stability of proteins
  • 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 9, 2018.

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
Senior 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

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Premier Sponsors:

Millipore Sigma
Unchained Labs