注射器
萃取(化学)
漏斗
化学
钨
污染
残余物
色谱法
火花塞
制浆造纸工业
材料科学
环境科学
冶金
计算机科学
环境工程
机械工程
工程类
生物
生态学
算法
作者
Liu Wei,R. M. Swift,Gianni Torraca,Yasser Nashed-Samuel,Zai‐Qing Wen,Yueyang Jiang,Aylin Vance,Anthony R. Mire‐Sluis,Erwin Freund,J.Lawrence Davis,Linda O. Narhi
出处
期刊:PubMed
日期:2010-01-01
卷期号:64 (1): 11-9
被引量:19
摘要
Particles isolated from a pre-filled syringe containing a protein-based solution were identified as aggregated protein and tungsten. The origin of the tungsten was traced to the tungsten pins used in the supplier's syringe barrel forming process. A tungsten recovery study showed that the vacuum stopper placement process has a significant impact on the total amount of tungsten in solutions. The air gap formed in the syringe funnel area (rich in residual tungsten) becomes accessible to solutions when the vacuum is pulled. Leachable tungsten deposits that were not removed by the supplier's wash process are concentrated in this small area. Extraction procedures used to measure residual tungsten in empty syringes would under-report the tungsten quantity unless the funnel area is wetted during the extraction. Improved syringe barrel forming and washing processes at the supplier have lowered the residual tungsten content and significantly reduced the risk of protein aggregate formation. This experience demonstrates that packaging component manufacturing processes, which are outside the direct control of drug manufacturers, can have an impact on the drug product quality. Thus close technical communication with suppliers of product contact components plays an important role in making a successful biotherapeutic.
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