蛋白质中质聚集体表征检测方案(图像粒度粒形)

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DKSH Characterizing protein aggregates in formulation development 表征配方开发中的蛋白质聚集体 Posted by Joyce Brown由 Joyce Brown 发表 AB BioTechnologies， Inc. located inBloomington， Indiana is a privately heldlaboratory offering pharmaceutical contractservices. Founder and CEO Dr. Jeff Schwegmanhas extensive experience in formulationdevelopment， lyophilization (freeze-drying) cycledevelopment and optimization， thermalcharacterization， and education and training in thedevelopment of injectable drug products. AB BioTechnologies， Inc。 位于印第安纳州布卢明顿，是一家私营实验室，提供药品有偿服务。创始人兼首席执行官 Jeff Schwegman 博士在配方开发，冻干(冷冻干燥)循环开发和优化，热表征以及注射药物产品开发的教育和培训方面拥有丰富的经验。 A typical AB BioTechnologies customer needs help with drug and diagnostic products invarious stages of development. They can require assistance with a wide variety with problemsranging from， "We just discovered a molecule to treat a disease. What do we do with it?" to，"We've got something developed and we're having problems getting it just right." 典型的 AB BioTechnologies 客户需要帮助处理不同开发阶段的药物和诊断产品。他们可能需要各种各样的帮助，其中包括“我们刚发现了一种治疗疾病的分子。我们用它做什么?”对，“我们已经有了一些发展的东西，对我们遇到的问题恰到好处。” When AB Biotechnologies completes a project for a customer they hand them a formulation， ora lyophilization cycle and manufacturing process that they can take to a licensed manufacturerto have their product produced. 当 AB Biotechnologies 为客户完成一个项目时，他们会向他们提供一个配方，或冻干循环和制造过程，他们可以将这些过程交给许可的制造商生产他们的产品。 The Challenge 挑战 AB BioTechnologies works with all kinds of customers with a wide variety of backgrounds，but mostly they talk to scientists. They help them when they need answers in regards todevelopment and freeze drying of injectable drugs. They also help business owners doing theinitial introduction of a formulation. Sometimes these companies are very small and consist ofjust a few people. If they don't have scientists on staff they contract AB BioTechnologies to dothe bulk of the development work. AB BioTechnologies 与各种背景的客户合作，但大多时候是与科学家交谈。当他们需要有关注射药物的开发和冷冻干燥的答案时， AB BioTechnologies 会帮助他们。它们还帮助企业最初引入配方。有时这些公司规模很小，只有少数几个人。如果他们没有工作人员，他们就会与 AB BioTechnologies 签订合同，进行大部分开发工作。 "We'll subject formulations to stress factors like freezing and freeze drying and then we'llmeasure and characterize the initial solution to get a base line，" says Dr. Schwegman."We addstabilizing excipients， then we'll freeze dry it again and reexamine the sample particles to see ifwe're generating any aggregates." “我们将冷冻和冷冻干燥等应力条件应用于配方，然后将测量和表征初始解决方案以获得基线，”Schwegman 博士说。“我们添加稳定的辅料，然后我们将其再次冷冻干燥并重新检查样品颗粒，看看我们这么做是否产生什么聚集体。 Protein aggregates can easily go undetected and they have the potential to denature and formaggregates， so finding them is a crucial step in the development process. Dr. Schwegman needsto be able to identify the progression of possible problems in his customer's formulations.蛋白质聚集体很容易被检测到并且它们有可能变性并形成聚集体，因此找到它们是开发过程中的关键步骤。Schwegman 博士需要能够确定客户配方中可能出现的问题的进展。 The Solution 方法 AB BioTechnologies 使用并推荐了许多供应商的实验室设备，但 Schwegman博士说，他的实验室检测蛋白质聚集体最重要的是 Fluid Imaging Technologies 的 FlowCAMQ动态成像粒子分析系统。 When Dr. Schwegman and his team are working on formulations that have the potential todenature and aggregate they do an excipient screen with the FlowCAM. Many proteinaggregates are translucent， so this can make them difficult to detect. 当 Schwegman 博士和他的团队正在研究具有变性和聚集潜力的配方时，他们会使用FlowCAM进行辅料筛选。许多蛋白质聚集体是半透明的，因此这使它们难以检测。 Having the ability to threshold on either darker pixels (relative to the background)， lighterpixels or both simultaneously can ensure proper protein aggregate characterization，especiallywhen working with high concentration formulations or those with a large amount of stabilizer. 具有对较暗像素(相对于背景)，较亮像素或两者同时进行阈值的能力可以确保合适的蛋白质聚集体表征，尤其是在使用高浓度制剂或具有大量稳定剂的时候。 A traditional method like light obscuration may miss protein aggregates， but the FlowCAM'scombination of imaging and flow microscopy allows Dr. Schwegman to characterizeparticulates with a high level of accuracy. "Image quality is extremely important whencharacterizing protein aggregates，" explained Dr. Schwegman.“We need to be able todifferentiate them from silicone oil and other contaminants in drug formulations early in theprocess. 像光阻法这样的传统方法可能会错过对蛋白质聚集体的捕捉，但 FlowCAM 的成像和流动显微镜结合使 Schwegman 博士能够高精度地表征微粒。 “在表征蛋白质聚集体时，图 像质量非常重要，，””Schwegman 博士解释说。“我们需要能够在过程早期将它们与硅油和其他污染物区别开来。22 The Results 结果 With its VisualSpreadsheetR software， the FlowCAM can record over 30 differentmeasurements per particle and can capture particle images at up to 22 frames per secondenabling AB BioTechnologies to quickly get the answers they need to drive the formulationdevelopment. 凭借其 VisualSpreadsheetQ软件， FlowCAM 可以为每个粒子记录30多种不同的测量值，并且可以以高达每秒22帧的速度捕获粒子图像，使 AB BioTechnologies 能够快速获得推动配方开发所需的答案。 “Data is one thing， but having instantaneous information is another，"says Dr. Schwegman.“The FlowCAM is an integral part of our screening process.” “数据是一回事，但拥有即时信息是另一回事，77”Schwegman 博士说。“FlowCAM 是我们筛选过程中不可或缺的一部分。”99 For example， if they need a do a screening of a monoclonal antibody formulation， they willfreeze dry it and see if aggregated particulates show up using the FlowCAM. If aggregatedparticulates are present， they know they now have to begin blending in some stabilizers. Theywill repeat the process of blending and running samples to help shape the formulation. 例如，如果他们需要对单克隆抗体制剂进行筛选，，他们会将其冷冻干燥并观察使用FlowCAM 是否出现聚集颗粒。如果存在聚集颗粒，他们知道现在必须开始混合一些稳定剂。他们将重复混合和运行样品的过程，以帮助建立配方。 AB Biotechnologies is a relatively small company， but they've been able to grow by finding theright technologies for their lab that help them service more customers more quickly and byoffering the best possible solutions. "If the FlowCAM wasn't part of our lab I'd have to contract out if I wanted to test for protein aggregates，” says Dr. Schwegman.“It just made sense tobring it in house." AB Biotechnologies 是一家规模相对较小的公司，但他们能够通过为实验室寻找合适的技术来帮助他们更快地为更多客户提供服务并提供最佳解决方案。Schwegman博士说：“如果 FlowCAM 不是我们实验室的一部分，那么如果我想测试蛋白质聚集体，我就不得不外协。?将它带入室内是合理的。 AB Biotechnologies has experience working with many different formulation types includinginjectable drug products， lyophilized powders， emulsions， and suspensions. With theirdevelopment services， a complete， optimized cycle can be designed in less than 30 days.Additionally， Dr. Schwegman provides training in product formulation and lyophilizationwithin the pharmaceutical and diagnostic industries. AB Biotechnologies 在处理许多不同的配方类型方面拥有丰富的经验，包括注射药物产品，冻干粉末，乳液和悬浮液。凭借其开发服务，可在不到30天的时间内完成完整，优化的循环。此外， Schwegman 博士还提供制药和诊断行业的产品配方和冻干培训。 AB Biotechnologies is just beginning to learn more about bioanalytical development and isbeginning to offer this service to their customers. The next phase for the business is going to bepre-clinical manufacturing， so they are making preparations in their lab to formulate materialsfor animal studies. AB Biotechnologies 刚刚开始更多地了解生物分析开发，并开始向他们的客户提供这项服务。 该业务的下一阶段将是临床前制造，因此他们正在实验室准备动物研究材料。 更多内容，关注“大昌华嘉科学仪器部”公众号 选择大昌华嘉，就是选择仪器应用专家Think Asia. Think DKSH.www.dksh-instrument.cn 电话：箱： ins.cn@dksh.com AB BioTechnologies，Inc。位于印第安纳州布卢明顿，是一家私营实验室，提供药品有偿服务。 创始人兼首席执行官Jeff Schwegman博士在配方开发，冻干（冷冻干燥）循环开发和优化，热表征以及注射药物产品开发的教育和培训方面拥有丰富的经验。“我们将冷冻和冷冻干燥等应力条件应用于配方，然后将测量和表征初始解决方案以获得基线，”Schwegman博士说。 “我们添加稳定的辅料，然后我们将其再次冷冻干燥并重新检查样品颗粒，看看我们这么做是否产生什么聚集体。” 蛋白质聚集体很容易被检测到并且它们有可能变性并形成聚集体，因此找到它们是开发过程中的关键步骤。 Schwegman博士需要能够确定客户配方中可能出现的问题的进展。