ABSTRACT

The ability to assess the potential for proteins to cause type 1 IgE allergic antibody-mediated hypersensitivity reactions is a daunting task. For safety professionals, being able to predict if a protein can cause this type of immune response under relevant conditions of exposure is key to safety and risk assessments. No

in vitro

tests exist that can predict the inherent potential of a protein to induce type 1 allergy, nor are any

in vitro

tests available that can estimate potential risk under relevant conditions of exposure. For this reason, safety professionals look to animal tests to help answer the basic questions of protein allergenicity.