Course Syllabus

Essentials of Cell Therapy Product Manufacturing, Qualification and Validation

Session 1: Developing a CAR-T Program

Speaker: F. Enrique Alvarez, BS, MLS (ASCP), CM, CQA (ASQ) and Indreshpal Kaur, PhD

MD Anderson Cancer Center

  • Recognize the value of the latest practical recommendations issued by the FDA regarding CAR-T product manufacturing submissions
  • Discuss how the generic CAR-T program development process has evolved since first introduced to industry in 2017
  • Compare the basic characteristics of the possible CAR-T starting materials described in IND submissions
  • Identify the shifting priorities, treatment options and challenges currently impacting a CAR-T program

Session 2: Developing a Validated Assay That Will Please the FDA

Speaker: Emily Hopewell, PhD

Indiana University School of Medicine

  • Provide a basic understanding of qualification and validation
  • Understand the types of parameters that can be assessed
  • Understand key considerations for assay validation
  • Discuss considerations for potency and stability testing

Session 3: Role of Manufacturing in Regulatory Submissions

Speaker: Kevin Bosse, PhD, RAC-US

Nationwide Children's Hospital

  • Recognize IND pathways and overall processes
  • Illustrate CMC module format and content
  • Learn the process to solve CMC-related issues of regulatory submissions
  • Identify FDA mechanisms for CMC discussions

Session 4: Cryopreservation and Stability

Speaker: Natalia Lapteva MS, PhD 

Baylor College of Medicine

  • Know the workflow for cell product downstream processing (Pre-freezing, freezing and thawing of cell therapy products)
  • Learn caveats for fresh and cryopreserved products
  • Discuss manual and automated cryopreservation
  • Learn about product stability studies -examples from CAGT
  • Discuss manual and automated thaw procedures