1. FACT-NetCord International Standards & Accreditation Foundation for the Accreditation of Cellular Therapy March 2007 Phyllis I. Warkentin, MD

2. NetCord-FACT Standards Goals To promote quality practices: maternal and donor selection, screening, and testing cord blood collection, process, testing, banking, selection, release, and transport. To consistently assure provision of quality CB units To permit research and development

3. Foundation for the Accreditation of Cellular Therapy - FACT Co-founded in 1996 by: American Society for Blood and Marrow Transplant International Society For Cellular Therapy Purposes: Establish and promote standards for quality medical and laboratory practice in hematopoietic progenitor cell transplantation and other cellular therapies Implement voluntary inspection & accreditation program JACIE – Joint Accreditation Committee of EBMT / ISCT Joint International Standards for Cellular Therapy Products

4. FACT-JACIE International Standards Scope and Content Standards apply to: Hematopoietic progenitor cells from any tissue source Therapeutic cells (nucleated cells other than HPC) Cover all phases of collection, processing, administration (excluding collection and banking of cord blood cells) Require all clinical, collection and laboratory facilities to: Develop and maintain a comprehensive Quality Management Plan Evaluate and report outcomes Comply with Applicable Law

5. Accreditation FACTJACIE Applicant programs248 90 Accredited 151 36 LocationsU.S.13 countries Canada Australia

6. 1996: FACT Standards for Hematopoietic Progenitor Cells 2000: International Standards for Cord Blood Banking 2002: International Inspection and Accreditation Program started 2006: Third Edition of Standards published

7. NetCord-FACT Standards: Scope and Content Cover all phases of cord blood collection, processing, testing, banking, selection, release Require all cord blood banks to: Maintain comprehensive Quality Management Program Utilize validated methods, supplies, reagents, equipment Maintain product tracking Maintain details of clinical outcome Comply with Applicable Law CBB must have a process to address every Standard

8. QUALITY MANAGEMENT  Covers all aspects of CB collection, processing, testing, banking, selection, release, and transport  Organizational Structure  Director  Medical Director  QM supervisor  Trained staff  QM Supervisor:  Maintain systems to review, revise, approve, implement all SOPs  Monitor compliance  Errors, accidents, biological product deviations, adverse events, variances, complaints

9. QUALITY MANAGEMENT  Covers all aspects of CB collection, processing, testing, banking, selection, release, and transport  Written process controls to ensure CB units:  Conform to specification  Are correctly identified – unique identifier  Are not contaminated or cross-contaminated  Maintain function / integrity  Management of non- conforming units  Maintenance of appropriate, safe and secure facilities  Detailed records  Documented agreements

10. Operational Standards  Cover all aspects of CB collection, processing, testing, banking, selection, release, and transport  Donor selection, screening, testing, eligibility determination  SOPs  Validation of processes, equipment, supplies, reagents  Detailed labeling requirements  Maternal samples, units, reference samples, documents  Bar-coding  ISBT 128  Specific assays for purity, potency:  infectious disease testing (mom)  HLA class I and II  TNC, CD34+ number  CFU (unrelated)  microbial testing  hemoglobinopathy  Unanticipated events:  Inventory transfer, cessation

11. FACT-NetCord Accreditation Voluntary accreditation Educational, collegial, helpful inspections Accommodates family units / banks and URD banks On-site inspection and written materials Must address each standard. No partial accreditation Volunteer inspectors, highly experienced in the field, peers – affiliated with accredited or applicant program Rigorous, two days, observe collections / processing Visit all sites (proportion of collection sites) Team report reviewed by FACT technical staff CB Accreditation Committee review; recommend action to Boards of NETCORD and FACT Improvements to achieve compliance required

12. FACT-NETCORD Cord Blood Bank Accreditation March 2007 CBB Applicants 5 4 US, UK, Europe, Asia ACCREDITED13 Non-US 9 Additional inspected 6 Non-US3

13. FACT-NetCord Standards International Acceptance Thirteen CBB accredited - US, UK, Europe Italy NETCORD-FACT Standards translated into Italian 2002 Published by Istituto Superiore di Sanità for clinical guidance Accepted as a recommendation by the Italian Ministry of Health

14. FACT-NetCord Standards International Acceptance Australia Therapeutic Goods Administration, Office of Devices, Blood and Tissues, regulates CB under Australian code of GMP and NetCord-FACT Standards WMDA – voluntary organization to establish international guidelines for collection and transfer of hematopoietic stem cells Adopted NetCord-FACT Standards for CBB Deemed status for accreditation AsiaCord Adopted NetCord-FACT Standards

15. FACT/NetCord Accredited Cord Blood Banks Banc de Cordó de Barcelona Barcelona, Spain Besançon Cord Blood Bank of the Etablissement Français du Sang Besançon, France BMDI Cord Blood Bank Melbourne, Victoria, Australia Carolinas Cord Blood Bank Durham, North Carolina, USA The Finnish Cord Blood Bank Helsinki, Finland José Carreras Cord Blood Bank Düsseldorf, Germany Liege Cord Blood Bank Liege, Belgium London Cord Blood Bank Edgware, Middlesex, United Kingdom MD Anderson Cord Blood Bank Houston, Texas, USA Milano Cord Blood Bank Milano, Italy National Cord Blood Program New York, New York, USA Pavia Cord Blood Bank Pavia, Italy StemCyte, Inc. Arcadia, California, USA

16. FACT/NetCord - Accreditation completed

17. Contact Information pwarkent@unmc.edu www.factwebsite.org