Immunogenicity study communication

KYMOS communication in the 10th EBF Symposium

Kymos presented an oral communication on the immunogenicity of gonadotrophines used for ovarian stimulation, during the 10th EBF Open Symposium held past 15-17 November 2017 in Barcelona. Kymos' Immunology Manager, Dr. Carles Morte, shared with the attendees the bioanalytical strategy followed and the results of two clinical studies. This work was done in collaboration with IBSA (Switzerland), the University of Basel (Switzerland), the Semmelweis University (Budapest, Hungary) and the Institut Universitari Dexeus (Barcelona, Spain).

Three ECLA (Electrochemiluminescence) methods were successfully developed, validated and applied to measure the presence of anti-drug antibodies (ADA) in two clinical studies. The first one was an immunogenicity study in healthy women undergoing controlled ovarian hyperstimulation with FSH. The second one was a safety and efficacy study of a new hMG formulation in patients undergoing ovarian stimulation for in-vitro fertilization. 

This immunogenicity study carried out in collaboration with several organizations represents a good example to show a kind of collaboration that Kymos can offer to biotech companies during the clinical development of innovative biologic drugs and biosimilars. Kymos has a wide experience in the development and validation of methods to assess the circulating levels of therapeutic proteins and determination of the ADA for their use in preclinical and clinical studies according to the GLP and GCP.

Download the presentation by clicking here:



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