过程分析技术在生物制品中的研究应用

Research and Application of Process Analysis Technology in the Development of Biological Products

生物医药在医药行业中占比逐渐增大,现代生物制药对产品质量和一致性控制提出了更高的要求,越来越多的过程研究工作致力于此。过程分析技术基于研发生产人员对产品属性及生产工艺的充分理解,融入到质量源于设计理念中,代表着未来生物医药行业的发展趋势。从质量源于设计理念及智能制造角度出发,阐述了过程分析技术在生物制品上游工艺、收获阶段、下游工艺、成品制备等过程中的最新应用研究。从微生物发酵、细胞培养、离心、复性、层析、配制、灌装、冻干等环节分析了过程分析技术应用的难易程度,并提出过程分析技术应用的挑战与前景。

The proportion of biopharmaceuticals in the pharmaceutical industry has been increasing gradually. Modern development of biopharmaceuticals place higher demands on product quality and consistency control, with more and more attention to process research. Based on the full understanding of product properties and production processes by R&D and production personnel, process analysis technology(PAT) has been integrated with the concept of quality by design(QbD), which represents the development trend of pharmaceutical industry in the future. In this paper, we expound the latest application of PAT for the production of biological products in the upstream, harvest, downstream and drug production in the biotechnological industry, from the view point of QbD and intelligent manufacturing. The difficulties of PAT application are discussed in microbial fermentation, cell culture, centrifugation, refolding, chromatography, formulation, filling and lyophilization, with the challenges and prospects for PAT application.