Sliwkowski M B, Cox E T
Genetech, Inc., South San Francisco, California.
Bioprocess Technol. 1990;10:179-206.
Because the structural parameters which influence product "quality" will vary from protein to protein, the screening methods used during development of each production process will also differ. Thus, not all of the methods described above will be needed for each product. One of the challenges of cell culture process development is choosing the correct structural features to monitor. The next level of process development may involve on-line control of many of the parameters discussed above. This would allow product quality-driven manipulations of culture conditions. The major factor limiting this advance may not be the techniques for real-time analysis, but rather a more thorough understanding of the structural features which describe a high-quality pharmaceutical protein.
由于影响产品“质量”的结构参数会因蛋白质不同而有所差异，所以每个生产工艺开发过程中所使用的筛选方法也会不同。因此，并非每种产品都需要上述所有方法。细胞培养工艺开发面临的挑战之一是选择正确的结构特征进行监测。工艺开发的下一个层面可能涉及对上述许多参数的在线控制。这将允许根据产品质量对培养条件进行操控。限制这一进展的主要因素可能不是实时分析技术，而是对描述高质量药用蛋白质的结构特征要有更透彻的理解。
