School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Manchester, UK.
Trends Biotechnol. 2013 Aug;31(8):448-58. doi: 10.1016/j.tibtech.2013.05.004. Epub 2013 Jun 14.
Over recent decades biotechnology has made significant advances owing to the emergence of powerful biochemical and biophysical instrumentation. The development of such technologies has enabled high-throughput assessment of compounds, the implementation of recombinant DNA technology, and large-scale manufacture of monoclonal antibodies. Such innovations have ultimately resulted in the current experienced biopharmaceutical stronghold in the therapeutic market. Yet aggregate prediction and profiling remains a challenge in the formulation of biopharmaceuticals due to artifacts associated with each analytical method. We review some emerging trends and novel technologies that offer a promising potential for accurately predicting and profiling protein aggregation at various stages of biopharmaceutical product design.
近几十年来，生物技术取得了重大进展，这要归功于强大的生化和生物物理仪器的出现。这些技术的发展使化合物的高通量评估、重组 DNA 技术的实施和单克隆抗体的大规模制造成为可能。这些创新最终导致了目前生物制药在治疗市场的强大地位。然而，由于与每种分析方法相关的伪影，在生物制药的配方中，总体预测和分析仍然是一个挑战。我们回顾了一些新兴趋势和新技术，它们为在生物制药产品设计的各个阶段准确预测和分析蛋白质聚集提供了有希望的潜力。
