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

  • Does terminology matter?
  • Practical FDA recommendations
  • Test method qualification requirements
  • Has the goalpost been moved?
  • Starting materials for IND-type products (tissues, cell lines) and manufacturing

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

Speaker: Emily Hopewell, PhD

Indiana University School of Medicine

  • Assay qualification or validation
  • Potency assay
  • Stability testing

Session 3: Role of Manufacturing in Regulatory Submissions

Speaker: Kevin Bosse, PhD, RAC-US

Nationwide Children's Hospital

  • CMC preparation and expectations
  • Considerations in filing an IND, FDA pathways, and designations
  • FDA interactions

Session 4: Cryopreservation and Stability

Speaker: Natalia Lapteva MS, PhD 

Baylor College of Medicine

  • Cryopreservation
  • Thawing methods
  • Stability studies