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微粒分析
能力和专业知识
西氏分析服务微粒实验室与客户深入合作，开发分析独特的给药或密封产品方法，或依据西氏自有的特定组件分析方法助力研究。微粒实验室通过开展测试，覆盖相容性研究至商业化和生命周期管理，在每个阶段都可为您的药品产品提供支持。我们具备处理一级和二级生物安全水平的药品产品能力，因此我们有信心与您深度合作设计研究，实现您的药品产品组合。
微粒表征和鉴别能力：
- 光学显微镜
- 傅里叶变换红外光谱学（FT-IR）
- 显微FT-IR扫描电子显微镜（SEM）/能量色散X射线光谱（EDS）
- 拉曼光谱
- 激光诱导击穿光谱（LIBS）
玻璃脱片仍然是生物制品储存的一个重要问题。对于具有高pH值的大分子制剂来说，情况更是如此。微粒实验室可以使用微分干涉反差显微镜（DICM）进行玻璃脱片测试，以确定选定的玻璃是否有可能发生玻璃脱片。此外，微粒实验室可采用下述技术进行微粒计数，确定可见和亚可见的微粒尺寸：
- 膜显微镜法
- 光学显微镜图像分析（LM/IA）
- 光阻法（LO）
全新技术
FlowCam®
FlowCam® 8100（Yokogawa Fluid Imaging Technologies）主要用于亚可见微粒分析。当悬浮在液体中的微粒通过流动池时，该仪器会捕捉到它们的数字图像。视野中捕捉到的每个微粒都有40多个形态特征，可用于创建微粒表征的图像库。该仪器使用符合《联邦法规21章》第11款的软件程序VisualSpreadsheet®处理捕获的图像，并生成包含微粒计数和尺寸的定制报告。
FlowCam 8100可用于监测药品产品中的微粒含量，并可作为早期阶段相容性研究中光阻法（LO）分析的补充。由于样品量要求较小 - 每次样品分析只需300 µL，因此是生物制剂的便捷之选。
了解微粒来源并能够区分内源性（与制造工艺有关）、外源性（与制造工艺无关）和内在固有（与产品有关）的微粒，对于了解处方中的微粒可能产生的风险至关重要。能够进行微粒表征的FlowCam可以确定微粒类型，从而更深入地了解药品产品中存在的微粒。
FlowCam® and VisualSpreadsheet® are registered trademarks of Fluid Imaging Technologies, Inc.
可下载的资源
携手共进
携手西氏，分析服务解决方案：使用USP第788章的方法1进行微粒分析。
携手共进
携手西氏，分析服务解决方案：使用USP第788章的方法2进行微粒分析。
专题博客
三月 02, 2021
Understanding Risks of Coring and Fragmentation of Rubber Stoppers
When it comes to choosing the right container closure system, a significant amount of focus is directed at addressing issues that may be a risk to safety and efficacy of the parenteral drug before it is introduced to a patient. Examples are testing of container closure integrity (CCI) and drug stability. Prior to drug administration by a health care professional, the rubber stopper is pierced with a needle, at least once. Stopper puncture testing also needs to be considered, especially if the closure system will be used in a multi-dose application.
四月 19, 2021
NovaPure® Components Answer Your Concerns over Particulates in Biologics
An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market.
四月 02, 2021
FluroTec™ Barrier Films – Protecting Your Biologics
There is no doubt biologics and biosimilars will remain one of the hot topics in 2021. This is due to the pandemic period of SARS-CoV-2 and the innovative treatments and vaccines that are under development at accelerated speed. Several questions can arise regarding selection of the proper primary package system for a biologic/biosimilar.
三月 02, 2021
Understanding Risks of Coring and Fragmentation of Rubber Stoppers
When it comes to choosing the right container closure system, a significant amount of focus is directed at addressing issues that may be a risk to safety and efficacy of the parenteral drug before it is introduced to a patient. Examples are testing of container closure integrity (CCI) and drug stability. Prior to drug administration by a health care professional, the rubber stopper is pierced with a needle, at least once. Stopper puncture testing also needs to be considered, especially if the closure system will be used in a multi-dose application.
四月 19, 2021
NovaPure® Components Answer Your Concerns over Particulates in Biologics
An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market.
四月 02, 2021
FluroTec™ Barrier Films – Protecting Your Biologics
There is no doubt biologics and biosimilars will remain one of the hot topics in 2021. This is due to the pandemic period of SARS-CoV-2 and the innovative treatments and vaccines that are under development at accelerated speed. Several questions can arise regarding selection of the proper primary package system for a biologic/biosimilar.
