Melody Janssen

Bioanalytical and immunogenicity expert

Dr. Janssen is an expert in bioanalysis and immunogenicity testing of biopharmaceuticals with in-depth experience as a project leader, trainer and senior expert in CROs and biotech companies. She worked predominantly on developing and validating ligand-binding and cell-based assays for PK/Tox and immunogenicity studies for biologics, biosimilars and vaccines and her work supported numerous regulatory filings. Dr. Janssen is experienced in the regulatory framework related to bioanalytical method establishment and validation including FDA, EMA, ICH guidelines and USP and Ph.Eur. monographs. She is frequently invited to speak at conferences on immunogenicity and bioanalytical testing, where she also leads conference specific workshops and seminars. So she has shared her knowledge in more than 40 workshops focusing on assay validation for bioanalytical, potency and immunogenicity assays for PTI, a London based organization offering training for professionals in pharma. Recently she became a regular evaluator for the Swedish innovation agency, Vinnova, where her task is to assess the scientific rational and business proposals of start-up biotech companies competing for seed funding.

Based on her role as the head of non-clinical development at Mymetics, a viral vaccine company, she has gained experience on aspects related to the production of biologics and vaccines, potency assays and GMP.

Dr. Janssen works as a freelancer and interim manager for projects that include non-clinical and clinical immunogenicity assessment, production of vaccines and biologics and teaching bioanalytical method validation workshops.

Dr. Janssen studied biology including subjects of virology and immunology in renowned institutes such as the Centers for Disease Control and Prevention in Atlanta. Her PhD, which was supervised by two internationally well-known experts in the field of immunogenicity, Prof. Huub Schellekens and Prof. Wim Jiskoot, investigated why biologics induce the formation of anti-drug antibodies (ADAs) especially in the presence of protein aggregates. She used transgenic mouse models to investigate the influence of product impurities such as aggregates and her group was able to establish a direct link between presence of aggregates and the increased likelihood of production of ADAs.