对用于初级澄清用辛酸法生产的蛇毒血清的动态主体进料过滤系统进行试验性评估

IF 3.6 Q2 TOXICOLOGY
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引用次数: 0

摘要

我们评估了动态给体过滤(DBF)在去除使用辛酸法生产蛇毒血清过程中产生的大块固体物质方面的性能。为此,在一项台式研究中对具有不同过滤特性的硅藻土进行了比较,以评估它们在去除向马高免疫血浆中添加辛酸后形成的沉淀物方面的效果。沉淀血浆浓度为 90 克/升的 C1000 硅藻土表现最佳。然后,将该工艺放大到三批 50 升高免疫马血浆。在这一试验规模中,血浆沉淀后的免疫球蛋白有 108 ± 4% 在 DBF 后被回收。使用该程序生成的抗蛇毒血清符合质量规格。与许多抗蛇毒血清生产商在工业规模上常用的开放式过滤系统相比,DBF 的产量相似,生产的滤液理化特性也相当。不过,DBF 能确保初级澄清的微生物质量,而开放式系统则无法做到这一点。这是因为1) DBF 是在深度过滤器的一次性封闭装置中进行的,可防止微生物污染,以及 2) DBF 可在几分钟内去除大块物质,而开放式过滤系统则需要 24 小时以上,因此降低了污染风险。结论是,DBF 是一种成本效益高、易于验证且符合 GMP 标准的替代方法,可用于蛇毒抗蛇毒血清生产中血浆的辛酸沉淀后的初级澄清。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Pilot-scale evaluation of a dynamic body-feed filtration system for primary clarification of snake antivenoms produced by the caprylic acid method

Pilot-scale evaluation of a dynamic body-feed filtration system for primary clarification of snake antivenoms produced by the caprylic acid method

The performance of dynamic body-feed filtration (DBF) in the removal of bulky solids produced during the manufacturing of snake antivenoms using the caprylic acid method was evaluated. For this purpose, diatomites with different filterability properties were compared in a bench-scale study to assess their effectiveness in removing the precipitated material formed after the addition of caprylic acid to equine hyperimmune plasma. C1000 diatomite at a concentration of 90 g/L of precipitated plasma showed the best performance. Then, the process was scaled up to three batches of 50 L of hyperimmune horse plasma. At this pilot scale, 108 ± 4% of the immunoglobulins present following plasma precipitation were recovered after DBF. The antivenoms generated using this procedure met quality specifications. When compared to open filtration systems commonly used at an industrial scale by many antivenom manufacturers, DBF has a similar yield and produces filtrates with comparable physicochemical characteristics. However, DBF ensures the microbiological quality of the primary clarification in a way that open systems cannot. This is because: 1) DBF is performed in a single-use closed device of depth filters which prevents microbial contamination, and 2) DBF removes bulky material in few minutes instead of the more than 24 h needed by open filtration systems, thus reducing the risk of contamination. It was concluded that DBF is a cost-effective, easily validated, and GMP-compliant alternative for primary clarification following caprylic acid precipitation of plasma in snake antivenom production.

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来源期刊
Toxicon: X
Toxicon: X Pharmacology, Toxicology and Pharmaceutics-Toxicology
CiteScore
6.50
自引率
0.00%
发文量
33
审稿时长
14 weeks
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