title: The use of rabbit polyclonal antibodies to assess neoantigenicity following viral reduction of an alpha-1-proteinase inhibitor preparation.
abstract: The objective of this study was to determine whether the viral reduction processes of nanofiltration and solvent/detergent treatment used in the manufacture of alpha-1 proteinase inhibitor (API) cause neoantigenic changes. Polyclonal antibodies were raised in rabbits against the treated API and quantitatively absorbed with an affinity column containing API that had not undergone viral reduction treatment. Antibodies before and after absorption were measured in a validated ELISA using the immunogen for antibody capture. Antibodies against novel API epitopes were not found after antiserum from rabbits inoculated with treated API was absorbed with untreated API. A positive control, consisting of serum obtained from rabbits inoculated with trinitrophenylated API, showed substantial amounts of measurable antibody following absorption with untreated API. The results suggest that the viral reduction process used does not result in the creation of API neoantigens.
authors.affiliation: Plasma Derivatives Department, American Red Cross, 15601 Crabbs Branch Way, Rockville, MD 20855, USA. doylej@usa.redcross.org
authors.forename: James W
authors.initials: JW
authors.lastname: Doyle
authors.forename: Gary L
authors.initials: GL
authors.lastname: Johnson
authors.forename: Nomi
authors.initials: N
authors.lastname: Eshhar
authors.forename: David
authors.initials: D
authors.lastname: Hammond
mesh_terms: D000818:Animals; D000906:Antibodies / Q000276:immunology*; D000956:Antigens, Viral / Q000032:analysis*; D004340:Drug Contamination; D004797:Enzyme-Linked Immunosorbent Assay; D000939:Epitopes / Q000032:analysis; D006801:Humans; D011817:Rabbits; D014462:Ultrafiltration; D000515:alpha 1-Antitrypsin / Q000276:immunology* / Q000592:standards*
chemical_list: D000906:Antibodies; D000956:Antigens, Viral; D000939:Epitopes; D000515:alpha 1-Antitrypsin