Statement of AABB before the Cellular, Tissue and Gene Therapies Advisory Committee

1. Statement of AABB before theCellular, Tissue and Gene Therapies Advisory Committee Joseph Giglio, MS MT(ASCP), CSQE(ASQ)CQA Deputy Director of Regulatory Affairs, AABB March 30, 2007 Draft Guidance on Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies www.aabb.org

2. Overview • Commend FDA for the time and effort put forth in drafting the guidance document • Review of draft document revealed a few areas of concern • Demonstration of Comparability • Additional flexibility required • Sterility Test Methodology • Requirement for NDC number

3. Demonstration of Comparability • Draft guidance does not adequately address requirements for previously manufactured products • What data is required to demonstrate comparability • Available mechanisms to release products that cannot be demonstrated to be comparable, for purposes of licensure • Use of products from Europe

4. Additional Flexibility Required • Hemoglobin testing sample type should be expanded to include post-volume reduction • Validation should be required only for processes that are performed, e.g., cryoprotectant removal

5. Sterility Test Methodology • Use of automated sterility methods • Necessity for validating the automated method vs the CFR method • If required, comment on the validity of submitting a collaborative validation study from multiple banks

6. Requirement for NDC Number • Not a good fit for this product • Facilities have adopted ISBT 128 as the labeling standard – superior to NDC system • ISBT 128 is accepted worldwide, NDC is not • Does not improve patient safety but in fact could decrease patient safety and increase deviations

7. Summary • Overall, this is a comprehensive and well prepared guidance document • Comments will be submitted to the docket by the close out date