药品颗粒中质量分析检测方案(图像粒度粒形)

智能文字提取功能测试中

CASE STUDY tBiotech Firm Chooses FlowCam for Quality Analysis FlowCam@ allows for easiermore accurate， and moreinformative subvisibleparticle analysis. "We demoed a couple particleanalyzers and we decided on theFlowCam because of the flexibilityin choosing objectives， ability todetect particles in the 5 pm range orless， and it provided real-time dataanalysis including particle count andshape"-David RhodesFormulation and Analytical Group，Protein Sciences Corporation THE CLIENT Protein Sciences Corporation is a biotech firm based in Meriden， Connecticut. Theirmission is to "save lives and improve health by responding to the changing worldthrough the creation of innovative vaccines and biopharmaceuticals."They producevaccines， therapeutics， and gene therapy products for clients and partners， andsupply product development and manufacturing services to the scientific community. THE CHALLENGE Prior to the FlowCam， David Rhodes， a member of the formulation and analyticaldevelopment group at Protein Sciences， and his team used two methods to analyzethe stability and subvisible particle content in their drugs： light obscuration andmanual microscopy. Light obscuration inaccurately counts and sizes amorphous andtransparent particles， and manual microscopy is time-consuming."Neither of thesemethods are very informative，" said Rhodes."For example， when we characterizedsamples known to contain particles， we weren’t able to adequately characterizethe sub-visible particulate. We knew [subvisible particles] were there but we didn'tknow how many， how big they were， or anything else." Rhodes was anxious to havesomething that analyzed subvisible particles faster， captured more information， andquantified more easily and accurately. contact@fluidimaging.com www.fluidimaging.com After doing some research on the available instruments on themarket， Rhodes determined that the FlowCam imaging particleanalyzer would provide the assessment of product quality hewas looking for. The FlowCam provides information on particlesize， concentration and appearance， and it also can characterizeagglomerates that are transparent and therefore not detectedby light obscuration devices. "We demoed a couple particle analyzers and we decided onthe FlowCam because of the flexibility in choosing objectives，ability to detect particles in the 5 pm range or less， and itprovided real-time data analysis including particle count and shape，" said Rhodes. “With the FlowCam， weget to see the particlemorphology insteadof just counts， and thatreally helps facilitate thedebugging process ifwe encounter any issuesduring the developmentof new products."// With its -David Rhodes VisualSpreadsheetQsoftware， the FlowCam canrecord over 40 differentmeasured properties perparticle and can captureparticle images at up to 60frames per second allowingfor high sampling efficiencyand fast analysis times. Itsorts and filters particledata and immediatelydisplays all similar-typeparticles. "The testingprocess is a whole lot easier， quicker， and more informative， in some ways， than theUSP <788> testing，" adds Rhodes. "It’s a question of taking 15minutes compared to taking a better part of a day." Rhodesestimates that this provides a 10-fold savings in laboratory costsfor Protein Sciences. STABILITY STUDIES WITH THE FLOWCAM The FlowCam is now used at Protein Sciences for routinetesting for subvisible particles in bulk drug substances anddrug products. When they have a new formulation or processand want to do a stability study， they include the instrumentas part of the testing at each point. This analysis characterizesthe potential degradation pathway of a product. "We’ll monitor[the drug] at one week， two weeks， or a month [in storage]to determine the progression of particle counts and particlesize，" said Rhodes. "With the FlowCam， we get to see theparticle morphology instead of just counts， and that really helpsfacilitate the debugging process if we encounter any issuesduring the development of new products." PRODUCT QUALITY WITH THE FLOWCAM Protein Sciences Corporation has improved overall productquality with the FlowCam. Their prior particle analysismethods of light obscuration and manual microscopy failedto provide them with enough accurate information and weretoo time consuming. By incorporating the FlowCam into theirformulation development， quality analysis，and stability studies，they have created a methodology that not only saves time andmoney， but results in superior products. Above： Protein particles asimaged with the FlowCam onday one. Left： Protein aggregates asimaged with the FlowCamafter four weeks. Size bar = 20 um in both CASE STUDY CONTINUED ON REVERSE FLUID IMAGINGTECHNOLOGIES， INC. ；FlowCam FlowCam®可实现更简单，更准确，更具信息性的亚可见颗粒分析。