PCR Assay Recommendations for Cell and Gene Therapies: Insights from an Industry Panel

Partner Presentation Speaker(s)

• 

  Amanda L. Hays, PhD

  Scientific Officer
  BioAgilytix
  Overland Park, Kansas
• 

  Mark C. Wissel, PhD

  Director, R&D
  Eurofins Viracor BioPharma
  Lenexa, Kansas
• 

  Kelly S. Colletti, PhD, MBA (she/her/hers)

  Director, Preclinical Bioanalytics
  Beam Therapeutics
  Cambridge, Massachusetts
• 

  Russell K. Soon, Jr. (he/him/his)

  Technical Scientist
  BioMarin Pharmaceutical, Inc.
  Novato, California

Moderator(s)

• 

  Tina S. Morris, PhD

  Executive Director
  AAPS
  Arlington, Virginia

Sponsored By:
1:15 pm - 2:30 pm: Presentation
2:30pm - 3:00 pm: Networking & Snacks

Description: The emerging use of qPCR and dPCR in regulated bioanalysis combined with an absence of regulatory guidance on assay validations for these platforms has resulted in discussions on lack of harmonization on assay design and appropriate acceptance criteria for these assays. A group of industry experts collaborated to create a consensus of best practices in the recently published “Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development.” The article, which was included in Volume 26 of the AAPS Journal, contains considerations on assay design, development, and validation testing for PCR assays that are used in cell and gene therapies including (1) biodistribution; (2) transgene expression; (3) viral shedding; (4) and persistence or cellular kinetics of cell therapies. In this session, the panelists will delve into the content of the manuscript, how they arrived at a consensus on these recommendations, and what it means in the rapidly growing biologics space.

1:15 pm - 2:30 pm - Panel Discussion
2:30 pm - 3:00 pm - Coffee and Snacks Networking

Click Here to View the Article

Learning Objectives:

• Upon completion, participants will be able to gain an understanding from the authors on how they arrived at these recommendations.
• Upon completion of the presentation, participants will be able to ask questions and provide feedback based on their experiences with PCR assays used to support cell and gene therapy development.
• Upon completion, participants will be able to use the knowledge to implement into their workflows.