Cambridge Healthtech Institute’s 4th Annual
Rapid Methods to Assess Quality & Stability of Biologics
Improving Prediction and Screening
Part of CHI's 8th Annual The Bioprocessing Summit
August 15-16, 2016 | Westin Boston Waterfront | Boston, Massachusetts
Assurance of quality and stability of biologic formulations over the course of intended usage is critical in developing safe and efficacious biopharmaceutical products. Increasing regulatory expectations and aggressive development timelines calls for rapid methodologies to predict and assess the quality and stability of biologics. The fourth annual Rapid Methods to Assess Quality & Stability of Biologics conference will bring together experts in analytical and formulation development to discuss regulatory expectations, prediction and manipulation for protein stability and instabilities cause by particles and impurities. We are seeking case studies and strategies, especially unpublished and innovative work, on methods employed in real time and accelerated stability studies, protein aggregates and effective use of DoE for assessment and data comparability from early to late stage development.
We invite you to submit a proposal to speak, present a poster, or to attend to learn from, and network with, the leading experts from around the world.
Topics may include, but are not limited to:
- Regulatory considerations and expectations for assessing quality and stability of biologics
- Rapid analytical techniques for the commercial quality control labs in preparation for regulatory filings
- Novel predictive techniques and computational modeling tools for studying aggregation and stability of proteins
- Risk assessment, prediction and analysis of stability issues
- High-throughput and high resolution screening to assess physical and chemical instabilities in protein in early development and what is their predictability correlation to late stage
- Automation and in-line tools in for stability analysis
- Automation, rapid in-process parallel monitoring, analysis and data management
- Protein aggregates, sub-visible particles and other particulates: Detection, characterization, regulatory perspectives, and immunogenicity
- Real time and accelerated stability testing
- New characterization approaches and state of the art techniques for analysis of residual host cell proteins, process impurities, aggregation, particles and sub-visible particles characterization, protein-protein interactions and degradants
- Challenges in working with small amount of API and formulation and using the information derived from early studies for late stage development
- Quality and stability assessment of very low and very high concentration protein formulation
- Analytical specification, acceptance ranges and handling of out of spec (OOS) results. Development, qualification, and implementation of biophysical methods
- 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.
Deadline for submission is February 15, 2016.
All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program. Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academia. Additionally, 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 more details on the conference, please contact:
Cambridge Healthtech Institute
Phone: (+1) 781-972-5421
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781-972-1359 | firstname.lastname@example.org
Business Development Manager
781-972-5412 | email@example.com
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