Cambridge Healthtech Institute’s 11th Annual

Characterization for Novel Biotherapeutics

Exploring the Analytical Challenges of Emerging Modalities

May 11-12, 2021


As new product formats 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 of Biotherapeutics conference explores the progression of analytical development for an exciting range of emerging modalities and offer 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:


Antibody-Drug Conjugates and Fusion Proteins

  • DAR for antibody-drug conjugates
  • Highly glycosylated Fc-fusion proteins
  • Method selection for payload characterization

Biotherapeutics for Difficult Targets

  • Agonist antibodies
  • Membrane proteins
  • Nanobodies and single chain molecules

Bi-Specific and Multi-Specific Antibodies

  • Assays for process characterization
  • Immunogenicity assessment
  • Method selection for different bispecific formats

Cell and Gene Therapies

  • Methods for AAV particle characterization
  • Design of potency assays
  • Method crossovers from proteins to cell and gene therapies

Drug Combinations

  • Pharmacology challenges: PK, ADA, interference, drug tolerance
  • Formulation development
  • Characterizing MOA individually and in combination


  • Characterization of mRNA vaccines and therapeutics
  • Lessons learned from rapid COVID vaccine development
  • Oncolytic viruses


If you would like to submit a proposal to give a presentation at this meeting, please click here.


The deadline for priority consideration is November 6, 2020.


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.


For more details on the conference, please contact:
Kent Simmons

Senior Conference Director

Phone: 207-329-2964


For partnering and sponsorship information, please contact:

Companies A-K

Jason Gerardi

Senior Manager, Business Development

Phone: 781-972-5452


Companies L-Z

Ashley Parsons

Manager, Business Development

Phone: 781-972-1340