• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Biotechnology Progress >Towards the Implementation of Quality by Design to the Production of Therapeutic Monoclonal Antibodies with Desired Glycosylation Patterns
【24h】

Towards the Implementation of Quality by Design to the Production of Therapeutic Monoclonal Antibodies with Desired Glycosylation Patterns

机译：通过设计实现质量的目标，以生产具有所需糖基化模式的治疗性单克隆抗体

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Quality by design (QbD) is a scheme for the development, manufacture, and approval of pharmaceutical products. The end goal of QbD is to ensure product quality by building it into the manufacturing process. The main regulatory bodies are encouraging its implementation to the manufacture of all new pharmaceuticals including biological products. Monoclonal antibodies (mAbs) are currently the leading products of the biopharmaceutical industry. It has been widely reported that glycosylation directly influences the therapeutic mechanisms by which mAbs function in vivo. In addition, glycosylation has been identified as one of the main sources of monoclonal antibody heterogeneity, and thus, a critical parameter to follow during mAb manufacture. This article reviews the research on glycosylation of mAbs over the past 2 decades under the QbD scope. The categories presented under this scope are: (a) definition of the desired clinical effects of mAbs, (b) definition of the glycosylation-associated critical quality attributes (glycCQAs) of mAbs, (c) assessment of process parameters that pose a risk for mAb glycCQAs, and (d) methods for accurately quantifying glycCQAs of mAbs. The information available in all four areas leads us to conclude that implementation of QbD to the manufacture of mAbs with specific glycosylation patterns will be a reality in the near future. We also foresee that the implementation of QbD will lead to the development of more robust and efficient manufacturing processes and to a new generation of mAbs with increased clinical efficacy.
机译：设计质量（QbD）是药品开发，制造和批准的计划。 QbD的最终目标是通过将其纳入制造过程来确保产品质量。主要监管机构正在鼓励其实施，以生产包括生物产品在内的所有新药品。单克隆抗体（mAb）是目前生物制药行业的领先产品。广泛报道糖基化直接影响mAbs在体内起作用的治疗机制。此外，糖基化已被鉴定为单克隆抗体异质性的主要来源之一，因此是单克隆抗体生产过程中要遵循的关键参数。本文回顾了QbD范围内过去20年中有关mAb糖基化的研究。该范围内的类别为：（a）单克隆抗体的理想临床效果的定义，（b）单克隆抗体与糖基化相关的关键质量属性（glycCQA）的定义，（c）评估存在风险的工艺参数的评估mAb glycCQAs，以及（d）准确定量mAb的glycCQA的方法。所有这四个领域的可用信息使我们得出结论，在不久的将来，将QbD用于具有特定糖基化模式的mAb的生产将成为现实。我们还预见到，QbD的实施将导致开发更健壮和高效的制造工艺，并带来具有更高临床功效的新一代mAb。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号