The phenomenon of protein aggregation is a complex conundrum that impacts biopharmaceutical development at virtually every stage.  All mechanisms of aggregation are not conclusively known, but the industry must use every effort to characterize and control this condition – and to reflect these efforts in regulatory filings.  A changing landscape of assays, instrumentation and processes support the need to collect, analyze and report this data.  Requirements for understanding the correlation between aggregates and immunogenicity shape analytical and clinical studies.  And aggregation resulting from new higher concentration protein formulations yields new challenges in drug product development, delivery systems and manufacturing processes.  The PEGS Protein Aggregation and Stability in Biopharmaceutical Products offers important scientific updates and a forum for dialog among the stakeholders in this challenging arena.

Topics may include, but are not limited to:

  • Aggregation and immunogenicity
  • Aggregation issues in new therapeutic modalities
  • Correlating aggregation and structure
  • Early methods for prediction of long-term stability
  • Measuring aggregation in forced degradation studies
  • Measuring and controlling in-use aggregation
  • Pre-aggregates and aggregation kinetics
  • The intersection of biopharmaceutical product aggregation and disease aggregation 
  • The molecular basis of different types of aggregation
  • Upstream and downstream process control of aggregation

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 Friday, September 25, 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 partnering and sponsorship information, please contact:

Kent Simmons
Senior Conference Director
Cambridge Healthtech Institute
Phone: 207-869-9199

Jason Gerardi
(Companies A-K)
Manager, Business Development
Cambridge Healthtech Institute
T: 781-972-5452

Carol Dinerstein
(Companies L-Z)
Director, Business Development
Cambridge Healthtech Institute
T: 781.972.5471