CBER 1 Disease Associated Antibody Donor Program Rosia E. Nesbitt, BS, SBB(ASCP), CQA(ASQ) Consumer...

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Disease Associated Antibody Donor Program

Rosia E. Nesbitt, BS, SBB(ASCP), CQA(ASQ)Consumer Safety Officer

CBER, OBRR, DBASeptember 16, 2009

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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

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Definition of Disease-associated Antibodies

• Antibodies that have occurred in response to exposure to disease agents or other antigens

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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

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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)

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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)

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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

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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

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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

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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

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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

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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)]

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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

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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

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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

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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/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm079673.pdf

• Guidance: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs (June 2007)

• http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm062905.pdf