Cambridge Healthtech Institute’s 13th Annual

Characterization for Novel Biotherapeutics  

Exploring the Analytical Challenges of Emerging Modalities

May 18-19, 2023


As gene and cell therapies and other new modalities progress through development and into the regulatory process, the role of analytical characterization is taking on new meaning. Very new modalities present challenges to both analytical scientists and regulatory agencies alike, and this steep learning curve requires a near-constant cycle of adaptation and innovation. The PEGS Characterization for Novel Biotherapeutics conference explores the progression of analytical development for an exciting range of emerging modalities and offers a case study forum for those working in the field to share ideas, experiences, and solutions that support the preclinical and clinical development of novel biotherapeutics.    


Coverage will include, but is not limited to:


  • Assays for neuroscience/BBB-crossing therapeutics
  • Cell therapies; characterization of clinical product, MOA
  • Characterization for novel formulations and delivery methods
  • Characterization with limited sample availability and volumes
  • DNA/RNA therapeutics
  • Hybrid molecules/formats
  • Large proteins
  • LNPs and viral vectors
  • Novel conjugates
  • Potency assays for novel formats
  • Regulatory impacts; CQAs for novel products, regulatory dialog/requirements, QC/lot release


The deadline for priority consideration is October 21, 2022.


All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute’s policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.


Opportunities for Participation:



For more details on the conference, please contact:

Kent Simmons

Senior Conference Director

Cambridge Healthtech Institute

Phone: 207-329-2964



For sponsorship information, please contact:

Companies A-K

Jason Gerardi

Senior Manager, Business Development

Cambridge Healthtech Institute

Phone: 781-972-5452



Companies L-Z

Ashley Parsons

Manager, Business Development

Cambridge Healthtech Institute

Phone: 781-972-1340