Flow Imaging Microscopy Blog

FlowCam can assess effects of mechanical stress (aggregation) on protein formulations in syringes resulting from hospital transportation systems.

University of Colorado PhD student, Vaida Linkuviene, along with Fluid Imaging Applications Scientist, Heather Anne Wright, and Co-Director of the Center for Pharmaceutical Biotechnology at the University of Colorado, John Carpenter, recently presented a poster at the 2019 Colorado Protein Stability Conference, at which Fluid Imaging has long been a participant. Vaida has been working with the FlowCam to assess the effects mechanical stress on protein formulations in syringes.

Pictured here: Vaida with her poster "Effects of transportation of syringes containing protein formulations through a hospital pneumatic tube system: Particle characterization by multiple methods"

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Topics: Protein Therapeutics, User Spotlight, Biopharmaceutical Research

Therapeutic Proteins Can Save Lives: Nano-Flow Imaging Helps Make These Drugs Safer

The positive impacts of therapeutic proteins on the lives of people suffering from cancer, diabetes, multiple sclerosis, Crohn’s disease, ALS, lupus, arthritis and other diseases and conditions have attracted significant investment in drug research and development.

As a result, hundreds of therapeutic protein-based drugs have earned FDA approval, with enormous benefits to human health. With the rapid growth and acceptance of these biologics, more and more information about impacts of product quality on patient outcomes has become available. Based on this growing body of evidence, one of the most important product quality attributes is the concentration and sizes of subvisible particles.

"Lives are on the line when it comes to correct understanding of how therapeutic proteins can form particulate" says Professor John Carpenter, PhD, Professor of  Pharmaceutical Sciences and Co-Director of the Center for Pharmaceutical Biotechnology at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences.

Read the entire article in Laboratory News

Click the infographic on the right to view larger

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Topics: Protein Therapeutics, Biopharmaceutical Research, Nanoparticles

FlowCam Compares Favorably to MFI and Light Obscuration: Collaborative Study by Japanese Biopharmaceutical Consortium

Currently the compendial method for quantifying subvisible particles equal to or greater than 10 µm and 25 µm uses light obscuration (LO), which is internationally harmonized in the U.S., European, and  Japanese Pharmacopoeia. However, numerous reports have indicated that subvisible particles smaller than 10 µm could elicit immune responses.

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Topics: Protein Therapeutics, Biopharmaceutical Research

UNE Researchers Use FlowCam to Study Engineered Proteins

A class of engineered proteins called elastin-like polymers (ELP) have shown promise for advanced drug delivery applications. In order to fully realize their potential however, they need to be rigorously characterized  to determine how they behave in different environments. The FlowCam is ideally suited to help with the characterization process.

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Topics: Protein Therapeutics, FlowCam Technology, Biopharmaceutical Research

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

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