Erythropoietin-Associated PRCA: Still an Unsolved Mystery.

摘要: The peak of erythropoietin-associated pure red cell aplasia (PRCA) incidents occurred over 4 years ago, but the debate on what triggered autoimmune disorder continues today. association with recombinant human erythropoietin (epoetin, rhEPO) alpha-branded Eprex (Johnson and Johnson), makes PRCA interest to medical scientific communities, as well biotechnology industry, it opens a broader question potential immunogenicity biopharmaceuticals in general. An overview background perspective current thought may assist avoiding repeat similar immunogenic cases other their emerging follow-on products. At same time, is also important clarify are relevant questions ask order ensure appropriate testing regulation biopharmaceuticals. upsurge associated formulation change introduced 1998 when serum albumin (HSA) protein stabilizer was exchanged polysorbate 80. Several explanations have been offered explain how this led Eprex-associated PRCA. Leachates from uncoated rubber stoppers acting adjuvant blamed by manufacturer Eprex, experimental data substantiating claim poor leachates theory has no biological rationale inconsistent epidemiological clinical data. A more likely explanation that consistent all higher tendency for aggregate formation during handling storage due exchange HSA 80 stabilizer.