In vitro TDAR: Developing a human in vitro T-cell dependent antibody response (TDAR) assay to assess immune enhancement

Immune modulators are defined as therapeutics that modify the immune response and are a rapidly growing drug class in preclinical drug development. Regulatory guidelines require that any potential adverse effects of new pharmaceutical agents are evaluated prior to use and recommend use of the in vivo T-cell dependent antibody response (TDAR) assay to assess immunotoxic effects, which is usually conducted in rodents or non-human primates. A robust in vitro human immune response assay could better predict clinical outcomes and reduce the number of animals used to assess immunotoxicity. 

Sponsored by Bayer AG, GSK, Merck Healthcare KGaA and Novartis Pharma AG, the aim of this Challenge is to develop a human in vitro TDAR assay to assess the immune enhancement properties of immunomodulatory therapeutics during drug development.  

Phase 2 funding has been awarded to a multi-disciplinary team led by Dr Karla Queiroz, Mimetas B.V. to deliver the project TDAR-on-a-chip: a human in vitro HTS TDAR assay platform.  

Full details about this CRACK IT Challenge can be found on the Innovation Platform website