Cambridge Healthtech Institute’s Fifth Annual
Characterization of Biotherapeutics
The Changing Analytical Function in an Era of New Product Formats
Part of the 11th Annual PEGS: the essential protein engineering summit
May 4-5, 2015 | World Trade Center | Boston, Massachusetts


As new product formats progress through development and into the regulatory process, the role of analytical characterization is taking on a new meaning. Regulatory agencies are themselves learning about these new formats, and to support filings, industry companies are being asked to provide ever more complex data across a wide range of analytical methods. The use of platformed analytical programs, developed as a cost and time saver by the industry, is now diminishing as novel molecules and product formats demand more individualized characterization steps. And instrumentation suppliers are striving to support this new era with unique product features, software and feature combinations. The PEGS Characterization of Biotherapeutics meeting will explore these changes in the progression of analytical development, and offer a case study forum for those working in the field to share ideas, experiences and solutions that support the development of exciting new biotherapeutics.

Topics will include, but are not limited to: 

  • Analytical development for novel molecules and product formats:
    • Antibody-drug conjugates
    • Bispecific antibodies
    • Fusion proteins and novel macromolecule conjugates
    • PEGylated molecules
    • Small protein formats and novel protein scaffolds
  • Analytical evaluation criteria for antibody product platforms
  • Characterization and control of product and process related impurities
  • Fitting novel molecules to existing analytical platforms
  • High throughput identification of critical quality attributes
  • Mass spectrometry for macromolecules
  • Miniaturizing biochemical assays
  • Strategies for determining comparability and biosimilarity


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