RAC, AB Consulting, Lansdale, Pennsylvania 19446
Tanzania
Review Article
Complexities of Protein Therapeutics and Immunogenicity
Author(s): Alok BandyopadhyayAlok Bandyopadhyay
Biopharmaceuticals like monoclonal antibodies are widely used in clinical medicine for various therapies e.g. cancer, inflammatory and autoimmune diseases. Immunogenicity is one of the issues for safety. Such undesired immunogenicity can also limit the use of biopharmaceuticals, particularly for the treatment of chronic diseases that necessitate repeated treatments over long period. Assessment of immunogenicity is an important component of drug safety evaluation, which is presently performed by estimating risk factors. Risk based approach considers both probability of induction of immune response and expected clinical consequences. A combination of the two may result in high, medium or low risk levels and will depend on the product, patient and treatment related characteristics. Well engineered cells, well designed formulation coupled with good manufacturi.. Read More»
DOI:
10.4172/1948-593X.1000126
Journal of Bioanalysis & Biomedicine received 3099 citations as per Google Scholar report