Immune Response Considerations

The administration of medicinal recombinant proteins raises the potential that the human immune system will recognize these proteins as foreign (1). A number of factors

From: Cancer Drug Discovery and Development Hematopoietic Growth Factors in Oncology: Basic Science and Clinical Therapeutics Edited by: G. Morstyn, M. A. Foote, and G. J. Lieschke © Humana Press Inc., Totowa, NJ

have been shown to either encourage or discourage immune assault. Oral or intravenous administration illicits weak immune responses, whereas subcutaneous or repeated administration strengthens the response (2,3). The immune response is sometimes exaggerated in patients with autoimmune disease and in patients with cancer or those treated with immunosuppressive therapies (4). The presence of extraneous proteins acquired during the industrial manufacturing may act as immune adjuvants, resulting in a heightened immune reaction (5).

Simple proteins, proteins with tertiary and quarternary structures similar to other "self" proteins, and proteins that are soluble tend to be either nonimmunogenic or less immunogenic than those that are complex, degraded, aggregated, or denatured (3,6). Glycosylation prevents exposure of the protein's molecular backbone to immuno-effectors and reduces the opportunity for the protein to encourage an immune response (7).

An exaggerated or abnormal immune response to the administration of an exogenous protein may have detrimental effects and result in adverse events. Antibodies (Abs) directed against the administered protein may cause the formation of antigen/Ab complexes that can affect that administered protein's pharmacokinetics, increasing clearance and decreasing efficacy. They can also be deposited in the skin or kidneys, leading to damage or malfunction (1). Neutralizing Abs may decrease the protein's expected potency and efficacy. Perhaps one of the most dreaded complications with the administration of HGFs is the occurrence of crossreacting Abs that are directed toward identical or similar endogenous proteins (8,9). Other concerns include the eliciting of either acute or delayed hypersensitivity reactions that may be so severe that they are life-threatening (7).

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