Flow Imaging Microscopy Blog

We are attending the European Workshop on Protein Aggregation and Immunogenicity

The 4th Annual European Workshop on Protein Aggregation and Immunogenicity will be held in Salzburg-Wals, Austria on January 28 and 29.  This conference serves as a European summit for thought leaders and academic researchers to come together and discuss the issues of protein aggregation and its effects on the immunogenicity of therapeutic protein drug products. We are excited to attend and exhibit the FlowCam imaging particle analyzer with our German distributor, Anasysta.

Proteins and contaminants from a parenteral drug sample, imaged and analyzed by the FlowCam.

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Topics: Nanoparticles, Biopharmaceutical Research, News and Events

Biotherapeutic Reformulation Achieved Through Extended Particle Analysis

Proteinaceous particles in parenteral drugs pose an immunogenic risk. These formulations are therefore rigorously characterized for optimal conformational and colloidal stability of the drug molecule. As such, they undergo thorough analysis of biophysical descriptors and extended particle characterization to ensure a safe and stable product is delivered to market with a shelf life of about two years. In this post, we summarize a recent paper by Mattison et al. (2018) published in BioProcess International on how they successfully reformulated biotherapeutics by using quantitative stability predictors and descriptors. 

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Topics: Biopharmaceutical Research, Protein Therapeutics, User Spotlight

Most Popular Flow Imaging Microscopy Blog Posts of 2018

We use our Flow Imaging Microscopy blog as a platform to serve up the latest in relevant news, highlight novel uses of the FlowCam, and announce FlowCam technology developments. This year we blogged about 54 different topics. Below is a recap of the Top 10 Most Read Blog Posts of 2018. 

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Topics: News and Events, Aquatic Research, Biopharmaceutical Research, FlowCam Technology, Marine Research, Protein Therapeutics, Harmful Algal Blooms

FlowCam for the Continuous Improvement of Manufacturing Process: A Case Study

A client in the biopharmaceutical market recently learned how the FlowCam is perfectly suited to visualize translucent plastic particles that may enter into their production process. They were frustrated with traditional microscopy that was not effective at visualizing microparticles. They turned to the FlowCam to troubleshoot their manufacturing process and were able to compare old and new data sets allowing for continuous improvement.

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Topics: User Spotlight, Industrial Applications, Biopharmaceutical Research

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