The human immune system is a complex set of cells and organs that can be adversely affected by drugs, resulting in increased susceptibility to infections and tumors, allergic responses to drugs, autoimmune reactions or other forms of immune system disease. Immunogenicity testing is an important consideration for therapeutic large-molecules. These therapies must be monitored, not only for potential immune responses but also for neutralization of the therapeutic agent.
The strategy for assessing cell-mediated immune responses induced by biologicals is generally less clear than for humoral responses. Assays need to be developed or selected on a case-by-case basis if these are required.
MDS provides the following services for evaluation of humoral, cell-mediated and innate immune responses to therapeutic molecules or vaccines.