FlowCam - Flow Imaging Microscopy Blog

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: Protein Therapeutics, User Spotlight, Biopharmaceutical Research

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

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

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: FlowCam Technology, Biopharmaceutical Research

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: Protein Therapeutics, FlowCam Technology, Biopharmaceutical Research, Nanoparticles

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: Protein Therapeutics, Biopharmaceutical Research

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: Protein Therapeutics, Biopharmaceutical Research, Nanoparticles

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

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

In 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: News and Events, FlowCam Technology, Biopharmaceutical Research