Disease Associated Antibody Donor Program Rosia E' Nesbitt, BS, SBBASCP, CQAASQ Consumer Safety Offi

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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/BiologicsBloodVaccine
  s/GuidanceComplianceRegulatoryInformation/Guidance
  s/Blood/ucm079673.pdf
• Guidance Informed Consent Recommendations for
  Source Plasma Donors Participating in
  Plasmapheresis and Immunization Programs (June
  2007)
• http//www.fda.gov/downloads/BiologicsBloodVaccine
  s/GuidanceComplianceRegulatoryInformation/Guidance
  s/Blood/ucm062905.pdf