Cambridge Healthtech Institute’s 3rd Annual
Rapid Methods to Assess Quality & Stability of Biologics:
Improving Prediction and Screening
August 3-4, 2015
Part of CHI's 7th Annual The Bioprocessing Summit
August 3-7, 2015 | Westin Copley Place Hotel | 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 the need of rapid methodologies to predict and assess the quality and stability of biologics. The third 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 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 We are seeking case studies and strategies, especially unpublished and innovative work, on methods employed in real time and accelerated stability studies, protein aggregates and effective use of DoE for assessment and data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
- How do we bring emerging technologies to enhance QC testing
- Novel predictive techniques and computational modeling tools for studying stability of proteins
- 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
- Sub-visible particles: 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)
- Automation, rapid in-process parallel monitoring, analysis and data management
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. Deadline for submission is January 30, 2015.
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 exhibit & sponsorship opportunities, please contact:
Manager, Business Development
For media partnership opportunities, please contact:
Director of Product Marketing