Applying International Standards for Quality Management: An Approach to Systems Design, Implementation and Production of the Highest Quality Umbilical Cord Stem Cell Product

Thomas Gordon Hirose

《Journal of Genetics and Molecular Biology》 12卷4期 (2001/12) Pp. 219-219

https://doi.org/10.30047/JGMB.200112.0015

並列摘要

Worldwide tens of thousands of patients, who are candidates for stem cell transplantation, succumb to their illness while waiting for a suitable bone marrow or peripheral blood donor to be found. Umbilical cord blood, otherwise discarded as biologic waste, may emerge as a key critical resource of multi-potent stem cells to support these patients.
Umbilical stem cell programs currently under development will benefit from the incorporation of principles developed, validated and practiced in the industrial manufacturing complex, pharmaceutical and blood banking industry, such as established by the International Organization for Standardization (ISO)(1)
Providing a pure, potent, consistent and efficacious umbilical cord stem cell product will require that the collection, processing and storage systems be based on Good Manufacturing Practice (cGMP). And must comply with the rapidly evolving body of international standards including: the National Marrow Donor Program (NMDP)(2), the “International Standards for Cord Blood Collection„ Processing, Testing, Banking, selecting and Release” Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT) (3), the proposed American Association of Blood Banks (AABB) first edition of Umbilical Cord Blood Hematopoietic Stem Cell Standards (4), Food and Drug Administration Code of Federal Regulation and through the protocols established in the ongoing investigation by the National Institutes of Health on Cord Blood Transplantation Study (COBLT) (5).