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Maintaining consistent quality and clinical performance of biopharmaceuticals

机译：维持生物制药的一致质量和临床表现

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Introduction: Biopharmaceuticals are large protein based drugs which are heterogeneous by nature due to post translational modifications resulting from cellular production, processing and storage. Changes in the abundance of different variants over time are inherent to biopharmaceuticals due to their sensitivity to subtle process differences and the necessity for regular manufacturing changes. Product variability must thus be carefully controlled to ensure that it does not result in changes in safety or efficacy. Areas covered: The focus of this manuscript is to provide improved understanding of the science and strategies used to maintain the quality and clinical performance of biopharmaceuticals, including biosimilars, throughout their lifecycle. This review summarizes rare historical instances where clinically relevant changes have occurred, defined here as clinical drift, and discusses modern tools used to prevent such changes, including improved analytics, quality systems and regulatory frameworks. Expert opinion: Despite their size complexity and heterogeneity, modern analytics, manufacturing quality systems and comparability requirements for the evaluation of manufacturing changes cumulatively help to ensure the consistent quality and clinical performance of biopharmaceuticals throughout their product lifecycle. Physicians and patients can expect the same safety and efficacy from biopharmaceuticals and their respective biosimilars irrespective of batch or production history.
机译：介绍：由于蜂窝生产，加工和储存导致的翻译后改性，生物制药是基于大蛋白质基于基于蛋白质的药物。由于它们对微妙过程差异的敏感性以及定期制造变化的必要性，因此由于它们的敏感性以及定期制造变化的必要性而导致的生物制药的丰富的变化是生物制药。因此，必须仔细控制产品变异，以确保不会导致安全性或疗效的变化。所涵盖的地区：本手稿的重点是提供对用于维持生物制药的质量和临床表现的科学和策略的理解，包括生物素质，包括生物素质的生物植物。本综述总结了稀有的历史实例，其中发生了临床相关变化，在此定义为临床漂移，并讨论了用于防止此类变化的现代工具，包括改进的分析，质量系统和监管框架。专家意见：尽管尺寸复杂性和异质性，现代分析，制造质量体系和对制造变化评估的可比性要求累计有助于确保生物制药的一致质量和临床表现整个产品生命周期。医生和患者可以期待生物制药及其各自的生物仿制物质的安全性和有效性，而不管批量或生产历史如何。

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