FACT-NetCord International Standards & Accreditation

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 StandardsScope 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 FACT JACIE Applicant programs 248 90 Accredited 151 36 Locations U.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 • QM Supervisor: • Maintain systems to review, revise, approve, implement all SOPs • Monitor compliance • Errors, accidents, biological product deviations, adverse events, variances, complaints • Organizational Structure • Director • Medical Director • QM supervisor • Trained staff

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 • 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 • 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

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 AccreditationMarch 2007 CBB Applicants 54 US, UK, Europe, Asia ACCREDITED 13 Non-US 9 Additional inspected 6 Non-US 3

13. FACT-NetCord StandardsInternational 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 BarcelonaBarcelona, Spain • Besançon Cord Blood Bank of the EtablissementFrançais 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