Cambridge Healthtech Institute’s Fifth Annual
Rapid Methods to Assess Quality & Stability of Biologics:
Improving Prediction and Screening
Part of CHI's Ninth Annual The Bioprocessing Summit
August 21-22, 2017 | Westin Copley Place | Boston, MA
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 fifth 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 caused by particles, higher order structures 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 We are seeking case studies and strategies, especially unpublished and innovative work on methods employed in real time and accelerated stability studies, protein aggregates and effective use of DoE for assessment and data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 reference standards
- Detection, characterization, and immunogenicity of protein aggregates, sub-visible particles and other particulates impurities
- High-throughput and high resolution screening to assess physical and chemical instabilities
- Real time and accelerated stability testing
- Novel predictive tools for studying aggregation, higher order structure (HOS) and stability of proteins
- Analytical specification, acceptance ranges and handling of out of spec (OOS) results. Development, qualification, and implementation of biophysical methods
- Automation, rapid in-process parallel monitoring, analysis and data management
- Detection and characterization of residual host cell proteins and other process impurities
- Quality and stability assessment of very low and very high concentration protein formulation
- Rationale study design and effective use of design of experiment (DOE)
Scientists who wish to present their knowledge and expertise to their colleagues are asked to click here to submit an abstract. Remember to specify the conference that you are interested in and please provide your full contact information.
The deadline for submission is February 17, 2017.
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:
For media partnership opportunities, please contact:
Director of Product Marketing
For exhibit & sponsorship opportunities, please contact:
Business Development Manager
Business Development Manager