Gilg D, Riedl B, Zier A, Zimmermann M F
R.W. Johnson Pharmaceutical Research Institute, a Division of Cilag AG, Schaffhausen, Switzerland.
Pharm Acta Helv. 1996 Dec;71(6):383-94. doi: 10.1016/s0031-6865(96)00048-9.
In the last twenty years many peptides and proteins were introduced to the market for pharmaceutical use. The high complexity of the biomacromolecules requires the use not only of physicochemical methodologies but also of immunochemical and biological techniques for the characterization and quality control of these substances. Characterization of the active conformation and post-translational modifications is important for the understanding of the in vivo activity of peptides and proteins. Among other spectroscopic techniques circular dichroism has become a helpful tool for evaluating the secondary and tertiary structure of proteins and peptides. A combination of several analytical methods is necessary for a comprehensive characterization of the substance under investigation and for an appropriate quality control of the product concerning identity, purity and potency. Suitable analytical methodologies are discussed using erythropoietin as an example.
在过去二十年中，许多肽和蛋白质被推向医药市场。生物大分子的高度复杂性不仅需要使用物理化学方法，还需要免疫化学和生物技术来对这些物质进行表征和质量控制。活性构象和翻译后修饰的表征对于理解肽和蛋白质的体内活性很重要。在其他光谱技术中，圆二色性已成为评估蛋白质和肽的二级和三级结构的有用工具。为了对所研究的物质进行全面表征，并对产品的身份、纯度和效力进行适当的质量控制，需要结合几种分析方法。以促红细胞生成素为例讨论了合适的分析方法。
