Werner Rolf G
Boehringer Ingelheim GmbH, Corporate Division Biopharmaceuticals, Binger Strasse 173, 55216 Ingelheim/Rhine, Germany.
J Biotechnol. 2004 Sep 30;113(1-3):171-82. doi: 10.1016/j.jbiotec.2004.04.036.
Sustained approvals of new biopharmaceuticals supported by a sparkling pipeline are the drivers for the above-market growth of biopharmaceuticals. Due to usually high therapeutic dose of monoclonal antibodies, they are demanding for high capacity needs. This requires significant capital investment and stimulates innovation for process improvement to decrease cost of goods and to save capital investments. Such process improvements are either ongoing along the learning curve or result from significant process changes through regulatory authorities impact. Both approaches require extensive protein analytical guidance to maintain product quality, safety and equivalency. In addition to second generation processes, second generation products have the feature of optimizing the physiological principle of biopharmaceuticals to the therapeutic need and to decrease the therapeutic dose, which goes along with investment savings and lower cost of goods.
源源不断的新生物制药获批，再加上一条亮眼的产品线，推动了生物制药高于市场水平的增长。由于单克隆抗体的治疗剂量通常较高，因此对高产能有需求。这需要大量资本投资，并刺激流程改进方面的创新，以降低商品成本并节省资本投资。此类流程改进要么是沿着学习曲线持续进行，要么是由于监管机构的影响而导致重大流程变更。这两种方法都需要广泛的蛋白质分析指导，以维持产品质量、安全性和等效性。除了第二代工艺外，第二代产品还具有将生物制药的生理原理优化以满足治疗需求并降低治疗剂量的特点，这与节省投资和降低商品成本相伴而生。
