As new product formats progress through development and into the regulatory process, the role of analytical characterization is taking on 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:

  • Advanced applications of mass spectrometry
  • Analytical challenges of drug combinations
  • Analytical development for emerging molecule and product formats (ADCs/targeted therapeutics, bioconjugates, bispecifics, fusion proteins, novel scaffolds)
  • Analytics by design – deviating from platformed analytical approaches
  • Binding assays (ligand binding, non-specific binding, stickiness)
  • Characterization of biosimilars
  • Characterizing solution characteristics
  • Development and validation of bioassays
  • Early analytical development – the collaboration between analytical, upstream and downstream processes
  • Emerging analytical methods (improved speed and resolution; automation)

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
E-mail: ksimmons@healthtech.com

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