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Project Brief


NIST Measurement Science and Engineering Research Grants

DEVELOPMENT AND VALIDATION OF AN IN VITRO HUMAN TESTBED FOR EVALUATION OF THERAPEUTIC ANTIBODIES


Use an advanced in vitro model of the human immune system, rather than those based on animals, to more accurately assess the potential toxicity and immune-system responses to monoclonal antibody drugs designed to help the immune system fight diseases such as arthritis and cancer.

RECIPIENT: VaxDesign Corporation, Orlando, FL

  • Project duration: 3 Years
  • Total NIST Funding: $1,499,990
In the past decade, new developments in genetic engineering and biotechnology have allowed the creation of bioengineered molecules, such as monoclonal antibodies, which are applied as novel therapeutic agents for treatment of conditions ranging from autoimmune disease to transplant rejection. The success of these therapeutic biologics has been undermined in part by potential immunogenicity elicited by some of these products, with consequences ranging from mild immune reactions to nearly fatal clinical problems. The prediction of unwanted immunogenicity and its clinical significance is complex; for example, conventional animal models are generally not suitable. There is a need to develop a reliable, human cell-based testbed to better evaluate both immunotoxic and immunogenic effects of biological compounds in the context of human response profiles, in essence, to perform a clinical trial in a test tube. To address this, the researchers will validate the reproducibility of the in vitro biomimetic MIMIC model of the human immune system for the assessment of the immunotoxicity and immunogenicity of monoclonal antibody biologics in an advanced in vitro artificial immune system. This will include enumerating and categorizing the profile of a range of monoclonal antibody biologics to be immunogenic.

Public contact (for project information):

Michael Rivard, 781-844-7252
mrivard@vaxdesign.com

NIST Program Office Contact:

Jason Boehm, 301-975-8678
Jason.boehm@nist.gov