Flow Imaging Microscopy Blog

New High-Throughput Method for Elastin-like Polymer (ELP) Coacervate Analysis

December 2018 — A recent study by researchers from the University of New England and University of New Hampshire has demonstrated that flow imaging microscopy is an accurate, more efficient, and more informative method of elastin-like polymer (ELP) coacervate analysis than standard methods. ELP coacervates are a class of molecules with promising applications in drug delivery vehicles, tissue engineering, environmental remediation, and more. ELP coacervate architecture is stimuli-responsive and highly tunable, making them ideal for the above-mentioned applications.  


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Topics: Nanoparticles, User Spotlight, Industrial Applications, Biopharmaceutical Research

5 Key Considerations for Particle Characterization of Biopharmaceuticals

Flow Imaging Microscopes provide the in-depth characterization of particles in protein therapeutics as recommended by the Food and Drug Administration (FDA). When evaluating instrumentation in this area, it is important to consider and compare these five important features.

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Topics: Biopharmaceutical Research, FlowCam Technology

Top 5 Influential FlowCam Papers for Biopharma

FlowCam_8100 w no backgroundThe FlowCam continues to be an important instrument in biopharmaceutical research. The ability to image and characterize morphological features of particulate in parenteral formulations is an important aspect of ensuring quality and safety in injectable drug products.

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Topics: Biopharmaceutical Research, Nanoparticles, FlowCam Technology, Protein Therapeutics

The Value of Flow Imaging in Quality Assurance for Drug Manufacturers

Today’s drug manufacturers are under increasing pressure to understand the particulate composition of their drugs, and to reduce and control particulate in their formulations. To reduce and control particulate matter, manufacturers must first understand its source. Traditionally, particle analysis has been accomplished via light obscuration (LO) and membrane microscopy. While having been the accepted analytical standard methods for particulate composition as outlined by USP <788>, experts have deemed them to be insufficient.

National Institute of Standards and Technology protein standard imaged by the FlowCam. Proteins and non-proteinaceous particles were captured by the FlowCam. 

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Topics: Biopharmaceutical Research, Protein Therapeutics

Detection of Subvisible Particulates in Bioformulations to Ensure Safety

NIST protein standards imaged on the FlowCam Nano at 40XBiopharmaceutical manufacturers strive to ensure patient safety, avoid recalls and protect company reputations. Identifying subvisible particles is an important step in preventing recalls of parenterals. One aspect of product safety is defined in the United States Pharmacopeia (USP) 788 guidelines for particle sizing.  This was designed to control for particles capable of causing capillary occlusion, and therefore focuses on particles larger than 10 µm and 25 µm. As such, no characterization is required for particles below 10 µm. 

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Topics: Biopharmaceutical Research, Nanoparticles, Protein Therapeutics

Technological Advances Push Protein and Particulate Research Further: Insights from the 2018 Workshop on Protein Aggregation and Immunogenicity

KentPetersonCEOFluidImagingTechnologiesKent Peterson is the CEO of Fluid Imaging Technologies.

Every summer, around 160 researchers converge at the Workshop on Protein Aggregation and Immunogenicity hosted in Breckenridge, Colorado by the University of Colorado Center for Pharmaceutical Technology and the AAPS Focus Group on Protein Aggregation and Immunogenicity. 

At the Workshop, scientists studying the behavior, formation, and effects of protein aggregates and other subvisible particles in therapeutic formulations gather to present their research and discuss industry issues.

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Topics: Biopharmaceutical Research, User Spotlight, FlowCam Technology, Protein Therapeutics, News and Events

Combined Light Obscuration + Flow Imaging Particle Analyzer to be Released 2019

In early 2019, Fluid Imaging Technologies will release the FlowCam+LO, a patent-pending flow imaging particle analyzer that simultaneously conducts light obscuration analysis.  

Light obscuration (LO) is the compendial method for analysis of subvisible particles and proteinaceous particles in therapeutic protein products, required by the US Pharmacopeia, European Pharmacopeia, and Japanese Pharmacopeia.  Beyond size and count, other morphological properties of particulate, such as shape, are not yet required. However, these properties may serve as quality and efficacy indicatorsand may influence the immunogenicity of the drug. Additionally, particle morphology can change over the course of a drugs life cycle if subjected to stresses such as agitation, temperature changes, or light exposure

 

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Topics: Biopharmaceutical Research, FlowCam Technology, News and Events

Japanese Consortium Assesses the Standardization of Flow Imaging Microscopy for Therapeutic Protein Regulations

In a recent study by Kiyoshi et al., a Japanese consortium conducted a collaborative study to assess the standardization of flow imaging microscopy (FIM) for the analysis of subvisible particles (SVPs) and protein aggregates in therapeutic protein products.

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Topics: Biopharmaceutical Research, Protein Therapeutics, User Spotlight

FlowCam Nano Earns Pharma Innovation Award

We are proud to announce that our FlowCam Nano has earned the Pharmaceutical Manufacturing 2018 Pharma Innovation Award.  Honored in the category of Analytical and Monitoring Devices, the FlowCam Nano particle analyzer is recognized as the industry's first ever flow imaging nano particle analyzer that provides digital images of particles ranging in size from 300 nm to 10+ µm.

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Topics: Biopharmaceutical Research, Nanoparticles, News and Events

Sub-visible dangers of plastic; nanoparticles in biopharmaceutical devices

Over the years, Fluid Imaging Technologies CEO, Kent Peterson has observed a shift in focus of process components in biopharmaceutical manufacturing from steel and glass to plastic (Single Use Technologies or SUT).  For sure there are advantages and disadvantages of each, from cost to breakage, to formulation interaction and stability.

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Topics: Biopharmaceutical Research, Protein Therapeutics, Nanoparticles