Comparing FlowCam Results with Light Obscuration

Comparing FlowCam Results with Light Obscuration: A Study by Japan’s National Institute of Health Sciences

In their recent publication, Quantitative Evaluation of Insoluble Particulate Matters in Therapeutic Protein Injections Using Light Obscuration and Flow Imaging Methods, Shibata et. al. compare the ability of Light Obscuration and Flow Imaging to detect and accurately characterize subvisible particles in injectable drugs.

The team at Japan’s National Institute of Health Sciences write the following:

Flow imaging (FI) has emerged as a powerful tool to evaluate insoluble particles derived from protein aggregates as an orthogonal method to light obscuration (LO). However, few reports directly compare the FI and LO method in the size and number of protein particles in commercially available therapeutic protein injections. In this study, we measured the number of insoluble particles in several therapeutic protein injections using both FI and LO, and characterized these particles to compare the analytical performance of the methods. The particle counts measured using FI were much higher than those measured using LO, and the difference depended on the products or features of particles. Some products contained a large number of transparent and elongated particles, which could escape detection using LO. Our results also suggested that the LO method underestimates the size and number of silicone oil droplets in prefilled syringe products compared to the FI method. The count of particles ≥10mm in size in one product measured using FI exceeded the criteria (6000 counts per container) defined in the compendial particulate matter test using the LO method. Thus precaution should be taken when setting the acceptance criteria of specification tests using the FI method.

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Characterisation of Membranes

Characterisation of Membranes

Porometer’s Instruments

Our porometers can be applied to the characterization of polymeric and ceramic membranes for micro and ultrafiltration applications with pore sizes ranging from 500 μm down to 2 nm. Flat sheet, tubular and hollow fibers can be measured by using an appropriate sample holder.

Best solutions

Both POROLUX™ series and POROLIQ™ series are suitable for membrane characterization as they offer fast and reproducible determination of first bubble point, mean flow pore size, smallest pore, pore size distribution, cumulative flow distribution & gas permeability.

Thanks to the unique designed components to guarantee the most accurate measurement of pressure and flow, and the intuitive and easy to use software, our porometers are the preferred partners of membrane scientists all over the world!

Contact us know to find out the most suitable model for you!

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Comparing FlowCam Results with Light Obscuration

Comparing FlowCam Results with Light Obscuration: A Study by Japan’s National Institute of Health Sciences

In their recent publication, Quantitative Evaluation of Insoluble Particulate Matters in Therapeutic Protein Injections Using Light Obscuration and Flow Imaging Methods, Shibata et. al. compare the ability of Light Obscuration and Flow Imaging to detect and accurately characterize subvisible particles in injectable drugs.

The team at Japan’s National Institute of Health Sciences write the following:

Flow imaging (FI) has emerged as a powerful tool to evaluate insoluble particles derived from protein aggregates as an orthogonal method to light obscuration (LO). However, few reports directly compare the FI and LO method in the size and number of protein particles in commercially available therapeutic protein injections. In this study, we measured the number of insoluble particles in several therapeutic protein injections using both FI and LO, and characterized these particles to compare the analytical performance of the methods. The particle counts measured using FI were much higher than those measured using LO, and the difference depended on the products or features of particles. Some products contained a large number of transparent and elongated particles, which could escape detection using LO. Our results also suggested that the LO method underestimates the size and number of silicone oil droplets in prefilled syringe products compared to the FI method. The count of particles ≥10mm in size in one product measured using FI exceeded the criteria (6000 counts per container) defined in the compendial particulate matter test using the LO method. Thus precaution should be taken when setting the acceptance criteria of specification tests using the FI method.

Read the full publication in the Journal of Pharmaceutical Sciences.

The results of this study corroborate the results produced in our FlowCam lab, comparing particle counts and sizes produced by the two technologies in our new instrument, FlowCam LO.
Our recently produced White Paper, “Measuring Subvisible Particles and Aggregates Using FlowCam LO”, uses FlowCam LO to directly compare the particle size distributions of aqueous samples containing Polystyrene Latex calibration beads, ETFE particles, and IgG aggregates. Download our White Paper to see the results of the study.
FlowCam LO uses two orthogonal techniques in a single instrument by combining our patented flow imaging microscopy technology with an embedded light obscuration particle counter. FlowCam LO provides an even more direct particle count comparison because a single aliquot of sample is analysed by both technologies in one sample run, instead of two samples from the same vial or syringe.

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Bettersize June

Bettersize June New Bulletin

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Welcome to the Bettersize June Newsletter!

This month, we bring you a new particle detective app video & app note, a collection of chemicals app notes, BeNano Series with flow mode, online store, and free sample testing service.

Hope you will enjoy! 😊

Particle Detective

Hunting for Clues in Battery

Join particle detective Viola as she hunts for clues to improve the energy density of EV batteries, which is crucial for extending electric range. Watch Now >

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Anode Energy Density of LIBs

In this application note, find out how the Bettersizer S3 Plus can be a valuable tool for measuring particle size and shape to determine the energy storage capacity of the anode in LIBs. Download Now >

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Chemicals App Notes Collection

This collection features six application notes showcasing the BeNano Series’ capabilities in analyzing diverse chemical materials, including polymer standards, surfactant micelles, copolymer latex, silica suspensions, aluminum oxide, and titanium oxide.

Download the collection and gain insights into selecting and applying effective techniques for your specific chemical analysis.

Download Now >

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Featured Instrument

BeNano Series

Frustrated with low-resolution particle sizing? The new BeNano is now equipped with DLS flow mode to transform your research. Combined with GPC/SEC or FFF, DLS flow mode can offer high-resolution size results, with better than 1.3x resolution to distinguish monomers, dimers, and aggregates in a polydisperse sample.

Get the brochure now to learn how BeNano and its DLS flow mode can empower your nanoparticle size measurements.

Download Now >

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Services and Support

Select and order the ideal instrument to meet your powder density testing needs now from the Bettersize online store. Submit your order here >

1️⃣ BeDensi T Pro Series – Tapped Density Tester
2️⃣ HFLOW 1 – Flowmeter Funnel
3️⃣ BeDensi B1-S – Scott Volumeter for metallic powders
4️⃣ BeDensi B1 – Bulk Density Tester for non-metal powders
5️⃣ BeDensi P – Bulk Density Tester – Plastic
6️⃣ BeDensi AR – Angle of Repose Tester

Want to test your sample before you buy? Submit your sample here >

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