title: Anti-A and anti-B titers in donor plasma, plasma pools, and immunoglobulin final products.
abstract: BACKGROUND
  High-dose intravenous immunoglobulin (IVIG) treatments are implicated in hemolytic events in some patients receiving treatment. The passive transfer of IgG anti-A and anti-B agglutinin is thought to play a role in the development of these events. The purpose of this study was to determine the prevalence of high-titer IgG anti-A and anti-B in plasma donors and investigate if there is any advantage of excluding these donors from the donor pool to limit anti-A and anti-B content in IVIG product.
  
  
  METHODS
  IgG anti-A and anti-B levels were assessed from group O donor plasma, manufacturing IgG plasma pools, and finished IVIG product (Gammagard Liquid). Antibody level in group O donors was also assessed by sex and age for their relative contribution of antibody to the plasma pool.
  
  
  RESULTS
  The majority of group O donors (80%) had antibody titers of less than 1000. Of those with titers of at least 1000, theoretical estimates provide further evidence that the effects of high-titer donors are minimal. Antibody levels in plasma pools both during the manufacturing process and from the final IVIG product also support that anti-A and anti-B levels are low. In general, there were more females than males with higher antibody titer levels, with significantly more females than males with anti-A.
  
  
  CONCLUSIONS
  Excluding donors with high anti-A and anti-B titers has minimal impact on the finished IVIG product titers due to ABO antibody neutralization and the dilution factor in the manufacturing pool.
authors.affiliation: Regulatory Affairs and Quality, Support Services Global QA/RA, Deerfield, Illinois.
authors.forename: John
authors.initials: J
authors.lastname: McVey
authors.affiliation: Regulatory Affairs and Quality, Support Services Global QA/RA, Deerfield, Illinois.
authors.forename: Don
authors.initials: D
authors.lastname: Baker
authors.affiliation: Quality Compliance, Baxter Healthcare Corporation, Westlake, California.
authors.forename: Rajesh
authors.initials: R
authors.lastname: Parti
authors.affiliation: Baxter Innovations GmbH, Vienna, Austria.
authors.forename: Roger
authors.initials: R
authors.lastname: Berg
authors.affiliation: PRO Unlimited, Deerfield, Illinois.
authors.forename: Maria
authors.initials: M
authors.lastname: Gudino
authors.affiliation: Baxter Innovations GmbH, Vienna, Austria.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Teschner
mesh_terms: D000017:ABO Blood-Group System / Q000097:blood / Q000737:chemistry*; D001782:Blood Donors; D046148:Donor Selection; D005260:Female; D006388:Hemagglutinins / Q000097:blood / Q000737:chemistry*; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000737:chemistry*; D007518:Isoantibodies / Q000097:blood / Q000737:chemistry*; D008297:Male; D010949:Plasma / Q000737:chemistry*
chemical_list: D000017:ABO Blood-Group System; D006388:Hemagglutinins; D016756:Immunoglobulins, Intravenous; D007518:Isoantibodies