1. CBER 1 Disease Associated Antibody Donor Program Rosia E. Nesbitt, BS, SBB(ASCP), CQA(ASQ) Consumer Safety Officer CBER, OBRR, DBA September 16, 2009

2. CBER 2 Outline Definition of Disease-associated Antibodies Examples of Disease Agents or Antigens Immunoglobulin M (IgM) Antibody Collection Disease-associated Antibody Program Informed Consent Reporting Program Implementation Label Submission Other Naturally Occurring or Pre-Existing IgG Antibodies References/Resources

3. CBER 3 Definition of Disease-associated Antibodies Antibodies that have occurred in response to exposure to disease agents or other antigens

4. CBER 4 Examples of Disease Agents or Antigens Chlamydia Coccidioidomycosis C-Reactive Protein Cytomegalovirus (CMV) Mononucleosis (Epstein-Bar Virus) Hemophilus influenza Hepatitis A (Anti-HAV) Hepatitis B core (Anti-HBc) – Anti-HBc collections allowed in this category only when donor is known to also have Anti-HBs

5. CBER 5 Examples of Disease Agents or Antigens (cont.) Hepatitis B (Anti-HBs) Herpes Type I and II Histoplasmosis Mumps Parvovirus B19 Pseudomonas Respiratory Syncytial Virus (RSV) Rubella Rubeola Toxoplasmosis Varicella Zoster (VZV)

6. CBER 6 Immunoglobulin M (IgM) Antibody Collection Program Plasma containing IgM antibodies or from donors who do not meet all donor suitability requirements are not covered under a disease- associated antibody program – Considered disease state donors – Submit as a Prior Approval Supplement under 601.12(b)

7. CBER 7 Disease-associated Antibody Program Manufacturers may implement a program to collect Source Plasma from donors who have detectable levels of disease-associated IgG antibodies Donors must meet all donor suitability requirements in 640.63 Donors should be in good health at time of donation

8. CBER 8 Disease-associated Antibody Program (cont.) Donors: – Should have either recovered from the disease or been exposed to the disease agent but remained asymptomatic – Possess specific IgG antibodies to the disease agent Source Plasma may be used in the manufacture of injectable and noninjectable products – Examples: IVIG; controls for in vitro diagnostic assays

9. CBER 9 Informed Consent In addition to the requirements in 640.61, donors: Should be informed that their plasma is being collected because it contains a specific antibody Should be informed that their antibody level will be monitored periodically to determine if they may continue participating in the program

10. CBER 10 Reporting Program Implementation Report in your Annual Report under 601.12(d) Include Form FDA 356h Annual Report should include statements that: – Donors met all required suitability criteria for Source Plasma donors in 640.63 – The plasma was collected from donors who have been exposed to the disease agent but are in good health at the time of collection

11. CBER 11 Reporting Program Implementation (cont.) Do not need to submit SOPs or the Informed Consent with the Annual Report Each program is facility specific – If implemented at more than one facility, submit a list of facilities and dates of implementation

12. CBER 12 Label Submission Submit labels for each pre-existing antibody as a CBE under 601.12(f)(2) Immunizing antigen (or antibody) must be on Source Plasma label [640.70(a)(7)]

13. CBER 13 Label Submission (cont.) Form FDA 2567 May submit a base label and include a list of different disease-associated antibodies with an explanation of placement on label Submit disease-associated antibody label for each facility if using address of each facility on label

14. CBER 14 Other Naturally Occurring or Pre-Existing IgG Antibodies Establishments may implement or expand the program to collect other naturally occurring or pre-existing IgG antibodies Donors must meet all suitability requirements in 640.63

15. CBER 15 Other Naturally Occurring or Pre-Existing IgG Antibodies (cont.) For donors with other naturally occurring or pre-existing red blood cell antibodies, submit a statement attesting that the donor: – Is not currently in an immunization program – Has not been immunized, either deliberately or by transfusion, within the previous 12 months Annual report should describe the procedures implemented to address these issues

16. CBER 16 References/Resources Label Regulations 640.70 Guidance: Implementing a Collection Program for Source Plasma Containing Disease Associated and Other Immunoglobulin G (IgG) Antibodies (August 2006) http://www.fda.gov/downloads/BiologicsBloodVaccines/Guida nceComplianceRegulatoryInformation/Guidances/Blood/ucm0 79673.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/Guida nceComplianceRegulatoryInformation/Guidances/Blood/ucm0 79673.pdf Guidance: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs (June 2007) http://www.fda.gov/downloads/BiologicsBloodVaccines/Guida nceComplianceRegulatoryInformation/Guidances/Blood/ucm0 62905.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/Guida nceComplianceRegulatoryInformation/Guidances/Blood/ucm0 62905.pdf