Statement of AABB before the Cellular, Tissue and Gene Therapies Advisory Committee
Draft Guidance on Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
Joseph Giglio, MS MT(ASCP), CSQE(ASQ)CQA Deputy Director of Regulatory Affairs, AABB March 30, 2007
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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
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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• Draft guidance does not adequately address requirements for previously manufactured products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
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Additional Flexibility Required
• Hemoglobin testing sample type should be expanded to include postvolume reduction • Validation should be required only for processes that are performed, e.g., cryoprotectant removal
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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
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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
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Summary
• Overall, this is a comprehensive and well prepared guidance document • Comments will be submitted to the docket by the close out date
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