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知识
西氏拥有一支专业且经验丰富的E&L团队，可在每个阶段为您提供支持以成功完成监管申报。根据当前的监管要求和指南，我们提供定制化的CGMP研究。在计划和执行可提取物和浸出物研究时，西氏遵循USP <1663>“药用包装/给药系统相关可提取物的评估”和 <1664>“药用包装/给药系统相关药物产品浸出物的评估”等法规的相关规定。我们在规划和研究装置时采用了ISO 10993-18标准，如SelfDose™和SmartDose®注射器。
专业知识
拥有近百年的弹性体丰富经验，西氏医药包装深耕组件及器械制造，拥有独特深刻的见解。
我们在以下产品领域拥有广博的专业知识：
服务
除了定制化的E&L研究服务，西氏分析服务还为4432/50 Gray和4023/50 Gray弹性体配方提供VeriSure™技术包。VeriSure™技术包所含文件可帮助制药和生物技术行业有效和主动管理这些领先弹性体配方中可提取物（潜在浸出物）的复杂问题。
浸出物调查的根本是弹性体组件的综合化学表征，其中通过进行受控提取研究来评估关键材料。VeriSure™技术包提供了丰富的可提取物信息，均为经过仔细评审的最新信息。
可提供其他弹性体配方的附加信息，包括：
欲了解上述技术包的更多信息，请联系我们的技术客户支持团队。
在提取研究期间采用的常见分析技术包括：
其他技术
制药和生物技术公司需要将密封系统或组合产品与分析专业知识相结合，以满足监管机构的期望，并在可提取物和浸出物研究过程中快速取得进展。为了帮助我们的客户，西氏分析服务开发了两项独特的工具——VeriSure®技术包，专门用于我们的4023/50 Gray和4432/50 Gray配方和E2L服务，支持其可提取物风险评估。
VeriSure技术包为可提取物提供了全面的技术包，客户可在线获取。这是专为我们的客户提供的服务，允许他们使用这些数据来支持他们的监管文件，证明他们的产品符合可提取物实验指南。该技术包是这些配方多年数据和研究结果的半定性汇编。可提取物数据使用了多种溶剂、提取条件和分析技术获得。研究变量包括：
E2L是一项提供提取物风险评估的服务，可确定哪些物质需要制造商在其浸出物研究中着重关注。风险评估报告有助于确定浸出物方法开发中的分析物。该评估基于可衡量的标准，会对可提取物评估中确定的每个可提取物进行评价，然后将风险归为以下3个类别：低风险、中风险和高风险。该报告内容包括风险评估所用标准的阐释、对可提取物采用颜色编码分类的参考表以及每个可提取物的总风险排名。虽然西氏的E2L可帮助我们的客户进行风险评估，但这并不意味着客户无需对其药品特定的浸出物进行风险评估。还须注意的是，分析服务实验室可为任何可提取物服务提供E2L风险评估，并不仅限于VeriSure技术包相关的可提取物服务。
VeriSure技术包和E2L风险评估可帮助客户高效地完成其包装组件的可提取物和浸出物研究的第一阶段。
携手西氏，分析服务解决方案 – 可提取物和浸出物测试
The concept of Extractables and Leachables (E&L) is well known today, especially since the publication of United States Pharmacopeia (USP) monographs <1663>1 and <1664>2. USP <1663> defined extractables as “organic and inorganic chemical entities that are released from a pharmaceutical packaging/delivery system and into an extraction solvent under laboratory conditions.” Leachables are defined in USP <1664> as “foreign organic and inorganic chemical entities that are present in a packaged drug product because they have migrated into the packaged drug product from a packaging/delivery system, packaging component or packaging material of construction under normal conditions of storage and use or during drug product stability studies.”
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission. Defined as extractables and leachables, these assessments continue to evolve and expand due to consistently increasing regulatory agency expectations. Agency expectations require you to act sooner rather than later. Waiting until Phase III in drug development can lead to delays and additional costs due to poor assessments that are questioned by the reviewer, or incomplete submissions that require you to redo or execute additional work. You can start your Extractables and Leachables (E&L) assessment as soon as you have selected your packaging components.
The FDA states: Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements.* While they make this statement, there is no prescription offered in actually how to execute an extractables and leachables evaluation, which is, of course, an essential aspect of demonstrating suitability of containers and closures.
The concept of Extractables and Leachables (E&L) is well known today, especially since the publication of United States Pharmacopeia (USP) monographs <1663>1 and <1664>2. USP <1663> defined extractables as “organic and inorganic chemical entities that are released from a pharmaceutical packaging/delivery system and into an extraction solvent under laboratory conditions.” Leachables are defined in USP <1664> as “foreign organic and inorganic chemical entities that are present in a packaged drug product because they have migrated into the packaged drug product from a packaging/delivery system, packaging component or packaging material of construction under normal conditions of storage and use or during drug product stability studies.”
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission. Defined as extractables and leachables, these assessments continue to evolve and expand due to consistently increasing regulatory agency expectations. Agency expectations require you to act sooner rather than later. Waiting until Phase III in drug development can lead to delays and additional costs due to poor assessments that are questioned by the reviewer, or incomplete submissions that require you to redo or execute additional work. You can start your Extractables and Leachables (E&L) assessment as soon as you have selected your packaging components.
The FDA states: Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements.* While they make this statement, there is no prescription offered in actually how to execute an extractables and leachables evaluation, which is, of course, an essential aspect of demonstrating suitability of containers and closures.
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