By Marco Weert, Eva Horn Møller
A selected factor for biopharmaceuticals that has no longer been addressed comprehensively in any e-book, is the potential for an immune reaction to the biopharmaceutical product. that's, the human physique marks the drug as a international physique, and develops antibodies opposed to the drug. those antibodies might be particularly risk free, yet can also cross-react with the endogenous compound, inflicting autoimmunogenicity. contemporary hostile stories in Europe with Janssen-Ortho s blockbuster product Eprex has elevated the eye in the direction of capability immunogenicity of biopharmaceuticals, primarily from the regulatory companies. This e-book is meant to offer a wide assessment of the present state of the art concerning the immune reaction to biopharmaceuticals. The chapters variety from an summary of the immune procedure and elements that could set off the immune process, through detection of antibodies and medical implications, to varied case examples and the regulatory view on immunogenicity.
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Additional info for Immunogenicity of Biopharmaceuticals (Biotechnology: Pharmaceutical Aspects)
Example text
1995. Immunological self-tolerance maintained by activated T-cells expressing Il-2 receptor alphachains (Cd25) – breakdown of a single mechanism of self-tolerance causes various autoimmune-diseases. J. Immunol. , and Lanzavecchia, A. 1995. Dendritic cells use macropinocytosis and the mannose receptor to concentrate macromolecules in the major histocompatibility complex class II compartment: downregulation by cytokines and bacterial products. J. Exp. Med. 182:389–400 Sallusto, F. and Lanzavecchia, A.
They were observed between 1998 and 2001 in different centres throughout Europe (Casadevall et al. 2002). In all these patients, anaemia was secondary to PRCA and neutralizing antibodies were present. All EPO-related PRCA patients showed an initial normal response to rhEPO and then developed severe anaemia, which was resistant to increasing dose as well as to a switch to another EPO. Anaemia appeared at different time points from the beginning of EPO treatment, with a median time of nine months (Bennett et al.
2001), in relapse rate and a lower rate of disease progression (Johnson et al. 1995, 1998, 2000, 2005). Development of anti-GA antibodies in treated patients is a known phenomenon, but the clinical meaning of anti-GA is not clear yet. Data from different studies give inconclusive results. The study by Brenner and coworkers (Brenner et al. 2001) showed that anti-GA antibodies developed only in treated patients and not in the placebo group and that antibodies titres peaked after three months, then slowly decreased but remained higher than baseline values.