Tetanus antitoxin potency assessment by surface plasmon resonance and ToBI test

Publication date: Available online 11 September 2019Source: BiologicalsAuthor(s): Wagner Quintilio, Josana Kapronezai, Daniela Yumi Takata, José Roberto Marcelino, Ana Maria MoroAbstractPotency testing of tetanus antitoxin must be performed in vivo, in a very painful, stressful and prone to high variability assay. It is, therefore, mandatory to find alternatives to this kind of potency assessment. Immunochemical tests as ELISA or ToBI test are already available but usually results in a poor correlation to the in vivo protection. Considering research and development of mono and oligoclonal antibodies against tetanus and the improvement of equine polyclonal antitoxin production and control, we developed an alternative instrumental test for tetanus antitoxin by using surface plasmon resonance. Tetanus antitoxin from hyperimmune equine sera (16 batches) were tested and the results indicated excellent concordance and correlation to the in vivo test (Lin's ρ = 0.9). This innovative approach should now be improved in order to extend it to oligoclonal and monoclonal human antibodies aiming to replace mice for the potency assessment of tetanus antitoxin especially during research and development steps.

Source: Biologicals - September 11, 2019 Category: Biology Source Type: research