檢測機構使用流動成像顯微鏡來表征蛋白質聚集體（二）

Since most manufacturers aim primarily for compliance, there is little incentive to learn more about the formation or introduction of particles present in compliant formulations. For example, under USP <788>, sub-visible particle testing is typically done in a lab away from the line where visual inspections are conducted for visible particles. Vials may be rejected from either test, but are not often evaluated together using orthogonal methods to determine what particles are triggering the rejections. Concern is focused on effectively rejecting off-spec vials rather than on identifying the type of particle detected and understanding why it is present.

由于大多數制造商主要致力于合規性，因此幾乎沒有動力去了解合規配方中存在的顆粒的形成或引入。 例如，在USP <788>下，亞可見顆粒測試通常在遠離對可見顆粒進行目視檢查線的實驗室中進行。 可以從任一測試中拒絕小瓶，但是通常不使用正交方法一起評估小瓶以確定哪些顆粒觸發不可接受條件。 關注的重點是有效地拒絕不合格的樣品瓶，而不是確定檢測到的顆粒類型并理解其存在的原因。

The situation faced
面臨的情況

According to Berdovich, this mind set is changing. “Most of my customers want to know more about their products than compliance requires, such as particle shape - it’s invaluable in case problems arise later in formulation - but you can’t find out much more if you’re using laser scatter or light obscuration devices,” he says.

根據Berdovich的說法，客戶的這種心態正在發生變化。 “我的大多數客戶都希望了解他們的產品，而不僅是合規要求，例如顆粒形狀 - 如果在配方中出現問題，這是非常寶貴的 - 但如果您使用激光散射法或光阻法，您就無法發現更多“他說。

The problem came to a head during another test that required measuring particles in a liquid or gel formed on a membrane. Since the particle shape deformed in minutes, the analysis need ed to be done quickly. Manual micros copy proved far too slow. Moreover, the particles deformed when filtered and squeezed between the glass slides. “We were bumping up against a wall and thought there was no way to do this,” says Berdovich.

在另一個需要測量膜上形成的液體或凝膠中的顆粒的測試中，又一個問題出現了。 由于顆粒形狀在幾分鐘內變形，因此需要快速完成分析。 手動微拷貝證明太慢了。 此外，顆粒在過濾并在載玻片之間擠壓時變形。 “我們碰到了一堵墻，并認為沒有辦法做到這一點，” Berdovich說。

Then he read in a trade magazine about new instrumentation called the FlowCAM^?, an imaging particle analysis system that automatically detects the presence of particles and microorganisms in a sample, including transparent, semi transparent and sub-visible particles. 

然后他在一本行業雜志上閱讀了一種名為FlowCAM^?的新儀器，這是一種顆粒成像分析系統，可自動檢測樣品中顆粒和微生物的存在，包括透明，半透明和亞可見顆粒。

The instrument’s software package does typical spreadsheet analysis operations on particle data while presenting the results visually as images- as opposed to tabular representation. It incorporates statistical pattern recognition for particle characterization, a big improvement over simple value filtering.

該儀器的軟件不僅對顆粒數據進行典型的電子表格分析，同時又以圖像形式呈現結果 - 而不僅僅是表格。 它結合了用于粒子顆粒表征的統計模式識別，這是對簡單值過濾的重大改進。

Not relying on scatter
不依賴于分散

Rather than rely on light scatter, the FlowCAM’s imaging technology captures a high-resolution, digital image of each individual particle passing in front of its flow cell. Imaging thousands of particles in seconds, it measures each one based on its actual image to yield data based on particle shape, size and transparency.

FlowCAM的成像技術不是依賴光散射，而是捕獲通過流動池前方的每個粒子的高分辨率數字圖像。 在幾秒鐘內成像數千個顆粒，它根據其實際圖像測量每個顆粒，根據粒子形狀，大小和透明度產生數據。

Clicking an image or touching the image on screen reveals the measurement data, which may be graphed several different ways depending on how the data needs to be visualized and the types of particles targeted.

單擊圖像或觸摸屏幕上的圖像會顯示測量數據，這些數據可能會以幾種不同的方式表達，具體取決于數據需要如何顯示以及所針對的顆粒類型。