Immunogenicity

Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal.

[5][6] Therefore, as stated by the World Health Organization, immunogenicity should be investigated in a target population since animal testing and in vitro models cannot precisely predict immune response in humans.

Consequently, they may require conjugation with an epitope such as a protein or polysaccharide to increase immunogenic potency so that they can evoke an immune response.

Although the exact mechanism is unclear, it is suspected that the mAbs are inducing infusion reactions by eliciting antibody antigen interactions, such as increased formation of immunoglobulin E (IgE) antibodies, which may bind onto mast cells and subsequent degranulation, causing allergy-like symptoms as well as the release of additional cytokines.

[18] One approach is to parse protein sequences into overlapping nonamer (that is, 9 amino acid) peptide frames, each of which is then evaluated for binding potential to each of six common class I HLA alleles that “cover” the genetic backgrounds of most humans worldwide.

Consequently, a number of biotech companies have integrated in silico immunogenicity into their pre-clinical process as they develop new protein drugs.