The rapid progress of cell and gene therapy products is giving rise to the need for greater insights into the mechanisms and development of these cell and gene therapy products. Analytical tools and approaches for characterization, stability and release testing of cell therapies, gene therapies, and gene-edited cell therapies thus become of paramount importance.


The 2nd installment in the Best-of Biotherapeutics Analytical Summit series presents a 1-day digital event that will showcase case studies, proven techniques and lessons learned to help companies harness the right technologies to speed innovation.


Topics may include, but are not limited to:


Session I: Analytical Characterization and Method Development

  • New methods for characterizing cell and gene therapy products
  • Flow cytometry for phenotypic characterization of cell therapy products
  • Analytical toolkit for characterization of allogeneic cell therapy products and autologous cell therapy products
  • Lentiviral-specific analytical techniques
  • Analytical methods for AAV characterization
  • Leveraging methods used for therapeutic proteins to cell & gene-based therapeutics

Session II: Bioassays, Potency and Cell-based Assay Development

  • In-vitro and in vivo functional bioassays for cell & gene therapy products
  • Immunogenicity assessment of cell & gene therapy products

Session III: Product Quality Attributes, Comparability & CMC

  • CQA identification and assessment for cell and gene therapy products
  • Control Strategies for cell & gene therapy products
  • Comparability of cell and gene therapy products during development and manufacturing
  • Aggregates and particulates impact on gene therapy products
  • Forced degradation studies of AAV biotherapeutics
  • Stability and release testing for cell and gene therapy products


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 27, 2020.


All proposals may be 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: Mimi Langley

Senior Conference Director

Cambridge Healthtech Institute

Phone: 781-972-5439 Email:


For partnering and sponsorship information, please contact:

Companies A-K

Jason Gerardi

Sr. Manager, Business Development

Phone: 781-972-5452 Email:


Companies L-Z

Ashley Parsons

Manager, Business Development

Phone: 781-972-1340 Email: