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首页> 外文期刊>PDA journal of pharmaceutical science and technology >Control Strategy Approach for a Well-Characterized Vaccine Drug Product
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Control Strategy Approach for a Well-Characterized Vaccine Drug Product

机译：控制策略疫苗药品的策略方法

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Trumenba (MenB-FHbp; bivalent rLP2086), the first meningococcal serogroup B vaccine approved in the United States and subsequently approved in Europe, Canada, and Australia, is well-characterized. Pfizer devised a control strategy approach by using a simplified control strategy wheel for Trumenba based on International Council for Harmonisation (ICH) Q8 (R2), Q9, Q10, and Q11 guidelines, which provide complementary guidance on pharmaceutical development, quality risk management, quality systems, and development and manufacture of drug substances, respectively. These guidelines ensure product quality using a scientific and risk-based approach. Trumenba contains two factor H binding proteins (FHbps), one from each of the two FHbp subfamilies (A and B), adsorbed onto aluminum phosphate. Trumenba manufacturing processes are complicated by the recombinant protein expression of Subfamily A and B proteins and the nature of the drug product (suspension in syringes); the latter also introduces challenges in controlling product critical quality attributes during the development process. In such complex systems, the control strategy is critical to ensuring consistent desired product quality; it also supports the regulatory requirement of continued improvement through continuous process verification and aids regulatory filing. This article describes Pfizer's approach toward robust control strategy development, built on product and process understanding, and links control strategy to regulatory document sections and flow of controls. Specifically, an approach is presented on product quality attribute criticality determination based on safety and efficacy and on an understanding of process parameter criticality. This was achieved by studying the impact of the approach on product quality attributes to define process parameter and in-process controls. This approach is further explained through Trumenba case studies, highlighting specific quality attributes and the associated controls implemented, and provides a holistic view of controls employed for both drug substance and drug product.
机译：TRUMENBA（MENB-FHBP; Bivalent RLP2086），美国批准的第一个脑膜炎血球菌血清疫苗B疫苗，随后在欧洲，加拿大和澳大利亚批准，具有很好的特色。 PFizer通过使用基于国际委员会（R2），Q9，Q10和Q11指南的国际委员会使用简化的控制策略轮来设计了控制策略方法，以便提供关于药物开发，质量风险管理，质量的互补指导系统，以及药物物质的开发和制造。这些指南使用科学和风险的方法确保产品质量。 Ruumenba含有两个因子H结合蛋白（FHBPS），来自两个FHBP亚壳（A和B）中的每一个，吸附在磷酸铝上。 Truumenba制造方法通过亚家族A和B蛋白的重组蛋白表达和药物产品的性质（注射器中的悬浮液）复杂化;后者还介绍了在开发过程中控制产品关键质量属性的挑战。在这样的复杂系统中，控制策略对于确保一致的期望产品质量至关重要;它还支持通过连续流程核查和艾滋病监管申请继续改进的监管要求。本文介绍了PFizer对强大控制策略开发的方法，基于产品和流程理解，并将控制策略链接到监管文件部分和控制流程。具体地，基于安全性和有效性以及对过程参数临界性的理解，提出了一种方法。这是通过研究方法对产品质量属性的影响来实现的，以定义过程参数和过程控制。通过Trumenba案例研究进一步解释该方法，突出特定的质量属性和所实施的相关控制，并提供用于药物物质和药物产品的控制的整体视图。

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