The use of rabbit polyclonal antibodies to assess neoantigenicity following viral reduction of an alpha-1-proteinase inhibitor preparation

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 (APT) cause neoantigenic changes. Polyclonal antibodies were raised in rabbits against the treated APT and quantitatively absorbed with an affinity column containing APT 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 APT 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 APT, showed substantial amounts of measurable antibody following absorption with untreated APT. The results Suggest that the viral reduction process used does not result in the creation of APT neoantigens. (c) 2005 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.