“…Indeed, even at a rHSA purity of 99.999%, 1 mg of impurities injected by the administration of 100 g of rHSA represents enough contaminating material to elicit an adverse immune response (Ohtani et al, 1998;Kobayashi, 2006). rHSA purified from P. pastoris is structurally identical to plasma-derived HSA (pdHSA) (Ikegaya et al, 1997;Kobayashi, 2006), and has shown comparable safety, tolerability, pharmacokinetics, and pharmacodynamics (Bosse et al, 2005;Kobayashi, 2006). In 2007, rHSA expressed in P. pastoris has been approved as a medicine, and in 2008 this rHSA has been launched in Japan for therapeutic purpose (Murasugi, 2010).…”