Development of reference standard for interferon α2a （IFNα2a） protein content determination
会议名称：《2010年中国药学大会暨第十届中国药师周》
会议日期：2010年
学科分类：1007[医学-药学(可授医学、理学学位)] 10[医学]
关 键 词：interferon α2a (IFNα2a) protein content determination reference standard Kjeldahl method high performace liquid chromatography(HPLC)
摘 要：Objective: Protein content determination is one of the most important quality control aspects for biotherapeutics, for instance Interferonα2a （IFNα2a）. The accuracy of protein content determination provides not only the quality control base for specific activity and filling of the biotherapeutics, but also an important reference data for stability evaluation, residual impurities control and other physiochemical properties identification. Currently, commercially available kits for total protein content determination provide bovine or human serum albumin as assay standard substance. However, systematic errors will be introduced to the test results inevitably due to the differences in amino acid composition between IFNα2a and serum albumin standard substance. Although some of the manufactures applied IFNα 2a itself as reference substance for protein content determination in the internal release control, the traceability background is not clear for the assigned protein content-they could not explain how they assigned protein content for the first batch of internal reference substance exactly. Recent years with the booming of the similar biotherapeutic products （SBP） including IFNα2a, more and more guidelines and regulations require a head to head thoroughly comparative study between similar biotherapeutic products （SBP） and reference biotherapeutic product （RBP）. Therefore, to develop a homogeneous standard substance for IFN α 2a protein content determination with clear traceability background will contribute to the IFNα2a quality control as well as the head to head comparative study. Method and Results: We carried out comprehensive quality control on one batch of rHuIFNα2a raw material provided by a Chinese manufacture, and all results comply with the requirements of Interferon alfa-2 concentrated solution monograph embodied in European Pharmacopoeia 6.0. Since Kjeldahl method consumes high concentration samples in large quantity, following strategy was applied. Firstl