FlowCam - Flow Imaging Microscopy Blog

New Study from Osaka University Compares FlowCam, MFI, and iSpect Data

In order to gain the most comprehensive understanding of particles in their samples, researchers often employ several instruments as part of their overall particle analysis scheme. Different technologies will assess different physical attributes of the particles and thereby offer scientists complementary data that are useful in validating their analyses. Even when two instruments perform essentially the same analytical technique, measurement differences between platforms may reveal physical property aspects that would otherwise go unnoticed. 

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Topics: Protein Therapeutics, User Spotlight, Biopharmaceutical Research

Flow Imaging Microscopy to Monitor Lipid Nanoparticle Aggregation

Lipid nanoparticles (LNPs) are gaining attention as effective drug delivery vehicles, especially since their successful use in the COVID-19 vaccines. Both Moderna and Pfizer SARS-CoV-2 vaccines depend on LNPs to deliver messenger RNA (mRNA), a delicate nucleic acid molecule, to the cytosol of target cells unharmed.

LNPs are a spherical assembly of lipid and/or lipid-like molecules that encapsulate and protect the therapeutic nucleic acid payload in the patient’s body. Like protein-based biotherapeutics, LNPs are subject to aggregation and other forms of degradation during storage periods and following stresses like freeze-thaw cycles or agitation due to sample (mis)handling.

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Topics: Protein Therapeutics, Biopharmaceutical Research, Nanoparticles

Characterizing Protein Aggregation With Orthogonal and Complementary Analytical Techniques

A central challenge with particle analysis in biotherapeutics is the wide size range of particles that may be present, including particles from the active pharmaceutical ingredient (API), as well as excipients and contaminants. These particles can be as small as a few nanometers (e.g., oligomer-sized protein aggregates, individual viruses) or large enough to be seen by the unaided eye (e.g., visible API aggregates). While several analytical techniques exist for particle monitoring, each can only analyze particles within a finite size range.

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Topics: Protein Therapeutics, Biopharmaceutical Research, Nanoparticles

McCrone Associates Adds FlowCam to their Suite of Analytical Instruments

The analytical lab at McCrone Associates (Westmont, IL) specializes in materials characterization and identification of particle contaminants and microscopic defects in a wide range of industrial and pharmaceutical materials. 

Historically, McCrone has not focused on enumeration. Their strengths have been in identifying materials at the micro- and nanometer scale using a variety of analytical techniques. With the addition of FlowCam to their analytical lab, they can now expand their enumeration capabilities by supplementing their current process with size distribution and concentration data. Additionally, morphological results from FlowCam will be directly correlated with the traditional microscopy-based results and identifications thereby enhancing the quality and statistical accuracy provided by particle enumeration projects. 

“There is great value in seeing images of the particles and of the actual contaminants,” says Dr. Craig Schwandt, Director of Industrial Services and Senior Research Scientist at McCrone Associates. “It allows us to identify particle type and particle source via morphology, which increases the strength of the finding.”

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Topics: Materials Applications, FlowCam Technology, User Spotlight, Biopharmaceutical Research

FlowCam at IFPAC 2022: Presenting Technological Innovations in Flow Imaging Microscopy

IFPAC, the International Forum for Process Analytical Chemistry, holds an annual conference that brings together scientists working in Process Analytical Technologies, QbD, Process Understanding & Control, and Real-Time Analytics. Professionals in these fields meet in person to discuss the latest trends and get ideas for the future of the industry. Research is presented in applications ranging from biopharmaceuticals to chemicals to food and beverage.

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Topics: Materials Applications, Protein Therapeutics, News and Events, FlowCam Technology, Food & Beverage, Biopharmaceutical Research, Nanoparticles

Introducing VisualAI: Integrated Artificial Intelligence for FlowCam

We're excited to announce the release of VisualAITM software for protein biotherapeutics. An add-on for VisualSpreadsheet 6, VisualAI is a pre-trained, AI-driven image analysis module to recognize images of subvisible aggregates in biotherapeutics captured on any FlowCam 8100 or FlowCam LO instrument.

VisualAI is a powerful tool for quantifying protein aggregate and silicone oil droplet content in any protein-based drug product.

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Topics: FlowCam Technology, Biopharmaceutical Research, VisualSpreadsheet

5 Key Benefits of Automating Flow Imaging Microscopy

Particle analysis is a critical but often tedious task for researchers in analytical laboratories. Data collection is not only time-consuming but can involve additional sample handling steps that introduce inconsistencies to the final measurements. Automation provides a natural solution to these issues, and automated liquid handlers (ALH) use robotics to perform sample processing enabling analysis with minimal human intervention. Automation not only vastly reduces the time and effort required from operators to perform experiments but, in the context of analytical instruments, helps users collect more reproducible and overall higher quality data.

Learn about the key benefits of adding automation to flow imaging microscopy and how these are implemented in ALH for FlowCamTM below.

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Topics: FlowCam Technology, Biopharmaceutical Research

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