单克隆抗体原液生产车间布置分析

Analysis of Layout of Workshop for Production of Monoclonal Antibody

结合我国GMP,欧盟GMP和FDA cGMP介绍了单克隆抗体生产的工艺特点,以某拟建单克隆抗体药物生产车间为例,介绍其布置特点:洁净分区和空调系统划分、压差分布和气流方向、人物流情况,在介绍人物流情况时,提供了另一种上下游不是物理隔断的布置作为对比。由于接种、发酵、粗纯、精纯四个单元中,各自的特点,各自设单独的空调系统。好的压差分布和气流方向可以更好地防止交叉污染,保护产品。在生产中需要用到接触生物活性物质的一次性袋子,并会产生含生物活性的废水,要对一次性袋子灭活,含有生物活性的废水也要先收集灭活。

Based on the rules in Chinese GMP, Europe GMP and FDA cGMP, the characteristics in the process of monoclonalproduction were introduced. Then exampled with one workshop for monoclonal drug production, its advantages and layout featureswere introduced, including cleaning division, air conditioning division, pressure differential distribution, air flow direction, peoplestream direction and goods flow direction. For people stream and goods flow, the layout form in which contrast flows of peopleand goods are not physically separated was presented. In the units of inoculation, fermentation, preliminary purification and finepurification, there were individually used air conditioners settled in view of their features existed respectively. With appropriatedpressure differential distribution and air flow direction, cross contamination can be prevented and the products protected. Inproduction, disposable bag which may touches active biological matter is used and the waste water containing active biologicalmatters is produced, thus it is necessary to inactivate disposable bags and waste water before they are delivered out.