1P-54 PDF
化学架橋と定量的レーザー散乱法を利用したバイオ医薬品の凝集体評価
Protein aggregation, which is responsible for undesirable consequences in a production of biopharmaceuticals, is not elucidated clearly due to possible complicated processes of formation. A particle size of the aggregates consisted with protein oligomer widely distributes from several ten nm to several 100 μm. Thus, an evaluation of the aggregates involves some analytical approaches. Chemical cross-linking bolstered with MALDI-TOFMS equipped with a high mass detector is a one of the recognized method to analyse protein aggregation. Whereas the cross-linking is applicable to IgG aggregates up to almost 10-mer, laser diffraction enables to measure sub-visible size of the aggregates. We will report an evaluation of the protein aggregation by using two methods.