REF: Bioanalytical Testing Considerations

1. FDA Guidance for Industry: Bioanalytical Method Validation, May 2018

2. FDA Guidance for Industry: Human Gene Therapy for Rare Disease, January 2020

3. BGTC Bioanalytical Strategy, June 2025

4. FDA Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products, November 2013

5. FDA Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products, August 2015

6. Chemistry, Manufacturing & Control Information for Human Gene Therapy Investigational New Drug Applications Guidance for Industry 1/2020

7. Potency Test for Cellular and Gene Therapy Products 1/2011

8. Intracellular Cytokine Staining

9. qPCR and qRT-PCR analysis