Cambridge Healthtech Institute’s Eight Annual
Protein Aggregation and Stability in Biopharmaceuticals
Analytic, Formulation, Manufacturing and Regulatory Challenges
Part of the 11th Annual PEGS: the essential protein engineering summit
May 7-8, 2015 | World Trade Center | Boston, Massachusetts


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. 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 control in very high concentration antibody formulations
  • Aggregation in delivery and packaging systems
  • Aggregation in novel molecule and product formats
  • Assay development and validation
  • Characterization and control of in vivo aggregation
  • Characterization of higher order structure
  • Engineering protein therapeutics for reduced aggregation
  • FDA immunogenicity guidance: impacts on regulatory filings and clinical development
  • Formulation strategies for aggregation control in biologic drug products
  • In-use aggregation
  • New understandings of the root causes of protein aggregation
  • Predicting and characterizing the mechanisms 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 October 3, 2014. 

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:
Kent Simmons
Program Director
Cambridge Healthtech Institute
Phone: 207-869-9199
E-mail: ksimmons@healthtech.com 

For partnering and sponsorship information, please contact:
Jason Gerardi (Companies A-K)
Manager, Business Development
Cambridge Healthtech Institute
T: 781-972-5452
E: jgerardi@healthtech.com 

Carol Dinerstein (Companies L-Z)
Director, Business Development
Cambridge Healthtech Institute
T: 781.972.5471
E: dinerstein@healthtech.com