FlowCam - Flow Imaging Microscopy Blog

Top FlowCam Studies for Biopharmaceuticals

Flow Imaging Microscopy (FIM) has emerged as an essential tool and an increasingly common approach in analytical labs for the quantification and characterization of particles in biotherapeutics. The body of scientific research using FlowCam technology to analyze biotherapeutic samples is continuing to grow and expand. 

These publications not only demonstrate the utility of FlowCam in biotherapeutic development and manufacturing but highlight exciting new applications for FlowCam such as artificial intelligence-based particle analysis as well as cell and gene therapy development.

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Topics: Protein Therapeutics, News and Events, Biopharmaceutical Research

Automated Liquid Handling to Streamline Your FlowCam Workflow

The new ALH for FlowCamTM Automated Liquid Handling system is ready for deployment in your lab. Automated liquid handlers (ALHs) use robotics to perform sample processing and analysis with minimal human intervention. Automation reduces the time and effort required from operators to process samples and offers improved repeatability, safer lab operation, and increased productivity.  

ALH for FlowCam provides unattended analysis of up to 384 samples and is compatible with all new and existing  FlowCam 8000 series instruments, FlowCam LO, and FlowCam Cyano.  The ALH offers flexible hardware and a configurable deck platform that allow the instrument to meet each user's specific workflow requirements, including sample preparation such as mixing, dilution and heating/cooling, as well as instrument cleaning. 

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

FlowCam Demonstrates Degradation of Protein Formulations After Transport in IV Bags via Hospital Pneumatic Tube System

Subvisible particles in biotherapeutics represent critical quality attributes because they pose regulatory and potential product safety risks. Therefore, much of the development work behind these therapeutics focuses on creating formulations and manufacturing processes that minimize the particle content in the drug product and reduce the potential for adverse immunogenicity. 

Pictured above are images of IV bags before and after transport via Pneumatic Tube System with Dextrose and Saline.

Despite measures taken during formulation and manufacturing, product quality can still be compromised after manufacturing due to accidental stresses caused by freeze-thawing, exposure to light, and mechanical shock from dropping the drug container. In a recent collaboration between the University of Colorado and Children's Hospital Colorado, researchers investigated particle generation in IV bags containing therapeutic protein formulations in the hospital's pneumatic tube system (PTS). Particle monitoring technologies like FlowCam are critical to ensure biotherapeutics have acceptable particle content not just after manufacturing but up until the therapy is administered to patients.

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Topics: Protein Therapeutics, Biopharmaceutical Research

White Paper: FlowCam Nano Provides Early Detection for Biotherapeutic Degradation and Contamination

Particles are ubiquitous in biotherapeutics and can drastically impact the efficacy of a given drug. Therefore, characterizing them is a critical step in biotherapeutic development, both to ensure samples meet particle limits set by regulations like USP <787/788>, and to maximize the safety and efficacy of the therapeutic.

New, innovative technologies may help researchers working with these therapies better understand the particles in their samples and, in turn, make more informed decisions about a sample’s quality. 

Download White Paper

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

Characterization of Protein Aggregates and Other Particles in Biopharmaceuticals

Particulates are ubiquitous in parenteral drug products and remain a concern throughout their development and production. These particles must be monitored to satisfy USP particle reporting requirements (e.g. USP <788>). Furthermore, in biopharmaceuticals such as protein therapeutics, these particles have been associated with adverse impacts on the efficacy and safety of the product. FDA regulations strongly recommend in-depth characterization of the quantity and types of particles found in biotherapeutics.

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Topics: Protein Therapeutics, FlowCam Technology, Biopharmaceutical Research

New Applications for FlowCam in Biotherapeutic Development

Pictured above, protein aggregates, sucrose particles, and E. coli as
imaged by FlowCam Nano. Equivalent spherical diameter (in µm)
for each particle is shown below their image.

Many new types of biotherapeutic Active Pharmaceutical Ingredients (API) such as viruses, nanomedicines including virus-like particles and lipid nanoparticles, and cell-based medicinal products have recently experienced a significant surge in interest. Like proteins before them, formulations of these APIs contain particles that need to be characterized to ensure product quality and efficacy. Particle characterization technologies like FlowCam thus continue to play a critical role in developing and manufacturing safe biotherapeutics regardless of the API. 

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

Meet FlowCam Nano: Submicron Particle Imaging and Sizing

We’re excited to announce the next-generation FlowCam Nano! The newest member of our FlowCam instrument family detects and images particles between 300 nm and 2 µm—the smallest objects visible by light microscopy.

FlowCam Nano can be used to determine the types of submicron particles present in samples, such as biotherapeutic particles or aggregates, drug delivery vehicles, bacterial cells, and other nanoparticles of interest. If not addressed, many of these smaller particles are prone to agglomeration into larger subvisible and visible particles. FlowCam Nano may be used to identify and mitigate these smaller particles before larger ones will form. Other species like bacterial cells inherently exhibit a size near or below the lower size limit of FlowCam 8000 and will only be detected by FlowCam Nano.

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

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.

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Topics: Protein Therapeutics, FlowCam Technology, User Spotlight, Biopharmaceutical Research

FlowCam and the BR1000 Together at BioProcess International Boston

Join us in Boston next week (booth #700) for the BioProcess International conference. This event represents our first combined marketing effort in the Life Sciences sector since our acquisition in 2020.

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Topics: Protein Therapeutics, FlowCam Technology, Biopharmaceutical Research

Morphological Filter Discrimination of Particulates in Injectable Therapeutic Formulations

Pharmaceutical and biopharmaceutical laboratories require rigid characterization of the particulate matter in injectable therapeutics. FlowCam technology offers a benchtop imaging particle analysis tool with unique software features that can discriminate particles based on morphological properties. The data obtained from FlowCam analysis can be used to verify the quality and integrity of parenteral drugs.

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Topics: Protein Therapeutics, Biopharmaceutical Research