Feldman F, Chandra S, Huang C
Technical Development Department, Armour Pharmaceutical Company, Collegeville, PA 19426, USA.
Acta Haematol. 1995;94 Suppl 1:25-32; discussion 33-4. doi: 10.1159/000204024.
The occurrence of viral transmission with coagulation factor concentrates treated with a single virus elimination step has resulted in a consensus that multiple virus elimination steps must be incorporated in the processing of these proteins. As an example of this methodology, the steps included in the purification of the factor VIII concentrate Monoclate-P are reviewed and those used to purify the factor IX concentrate Mononine--monoclonal antibody chromatography, sodium thiocyanate incubation, and a novel ultrafiltration system--are described. Rigorous quality control/quality assurance during processing is essential. The ultimate safety of the product used clinically further requires monitoring of long-term stability and verification of the absence of neoantigens that could stimulate unusual levels of antibody formation. Standardization of regulatory compliance will further strengthen the safety of all products. The zeal to add further barriers to viral contamination should not compromise the timely assessment of these additional protections.
采用单一病毒去除步骤处理的凝血因子浓缩物出现病毒传播，这已达成一种共识，即这些蛋白质的加工过程必须纳入多个病毒去除步骤。作为该方法的一个例子，回顾了凝血因子VIII浓缩物Monoclate-P纯化过程中所包含的步骤，并描述了用于纯化凝血因子IX浓缩物Mononine的步骤——单克隆抗体色谱法、硫氰酸钠孵育和一种新型超滤系统。加工过程中严格的质量控制/质量保证至关重要。临床使用产品的最终安全性还需要监测长期稳定性，并验证是否不存在可能刺激异常抗体形成水平的新抗原。监管合规的标准化将进一步加强所有产品的安全性。增加病毒污染额外屏障的热情不应影响对这些额外保护措施的及时评估。
