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PAT for vaccines: the first stage of PAT implementation for development of a well-defined whole-cell vaccine against whooping cough disease

机译：疫苗的PAT：开发针对百日咳疾病的定义明确的全细胞疫苗的PAT实施的第一阶段

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Since variation in process time and process output is commonly accepted to be inevitable for biological processes, application of Process Analytical Technologies (PAT) on these processes is challenging. In this paper the applicability of PAT on the cultivation of Bordetella pertussis bacteria as part of the manufacture of a vaccine against whooping cough disease is investigated. Scrutinizing and eliminating the most prominent sources of variance make the cultivation process step highly reproducible. Furthermore, the use of DNA microarrays allows investigation of how disturbances influence cellular physiology and product quality. Marker genes for product quality were identified, providing the means to quantitatively assess product quality, which is hardly possible using the mandatory animal tests for product quality. The tools and results described in this paper, combined with suitable on line measurements, can make full PAT application for this process step possible. Ultimately, the process can be designed and controlled towards consistent end product quality.
机译：由于通常认为过程时间和过程输出的变化对于生物过程是不可避免的，因此在这些过程上应用过程分析技术（PAT）充满挑战。本文研究了PAT在百日咳博德特氏菌培养中作为百日咳疾病疫苗生产的一部分的适用性。仔细检查并消除最突出的差异来源，可以高度重现栽培过程中的步骤。此外，DNA微阵列的使用允许研究干扰如何影响细胞生理和产品质量。鉴定了用于产品质量的标记基因，提供了定量评估产品质量的方法，而使用强制性动物产品质量测试几乎是不可能的。本文所述的工具和结果，加上适当的在线测量，可以使该过程步骤的完整PAT应用成为可能。最终，可以对过程进行设计和控制，以实现一致的最终产品质量。

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