Bhamra K, Harrison P, Phillips J, Hale G
Therapeutic Antibody Centre, Oxford, UK.
Methods Mol Med. 2000;40:313-7. doi: 10.1385/1-59259-076-4:313.
Ideally, injectable drugs are sterilized in their final containers by a foolproof method like autoclaving. This is not possible for biologicals like monoclonal antibodies (mAbs), so they must be manufactured aseptically, sterilized by filtration and then filled into sterile vials or ampoules. The final filling procedure is the most critical aseptic process and should be done in a very clean environment. Automatic machines are used for large production processes and eliminate the risk of contamination associated with manual processes. However, preparing material for early clinical trials can be problematic because the batch size is normally too small for a filling machine (e.g., 500-1000 vials). Normal practice is to fill this number of vials by hand, but the vials and closures have to be washed, depyrogenated (by baking in an oven), and sterilized, and the filling has to be carried out in a very strictly controlled environment, because the vials are open throughout the process and are only stoppered and sealed in a second step.
理想情况下，注射用药物应在其最终容器中通过像高压灭菌这样万无一失的方法进行灭菌。对于单克隆抗体（mAb）等生物制品而言，这是不可能的，所以它们必须在无菌条件下生产，通过过滤进行灭菌，然后装入无菌小瓶或安瓿中。最终灌装程序是最关键的无菌操作过程，应该在非常洁净的环境中进行。大型生产过程使用自动机器，消除了与手工操作相关的污染风险。然而，为早期临床试验准备材料可能会有问题，因为批量通常太小，不适合灌装机器（例如，500 - 1000个小瓶）。通常的做法是手工灌装这个数量的小瓶，但小瓶和瓶塞必须进行清洗、除热原（通过在烤箱中烘烤）和灭菌，并且灌装必须在非常严格控制的环境中进行，因为小瓶在整个过程中都是开放的，只是在第二步才进行加塞和密封。
