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FlowCam Product

About FlowCam — Technology & Capabilities

FlowCam instruments are advanced flow-imaging-microscopy-based particle analyzers, designed to capture high-resolution images of particles in liquid samples (300 nm – 5 mm) and deliver detailed morphological, concentration, and size data.
They provide image-based insights that go far beyond light-obscuration or laser-diffraction particle counting.

Built for biopharmaceutical, cell, and gene therapy applications, FlowCam helps identify, classify, and control subvisible particles, aggregates, cells, LNPs, and process impurities, as recommended by USP <1788>.

Key Capabilities

    • Identify and quantify subvisible/submicron particles in biologics and nanoparticle formulations.
    • Gain insight into particle sources within formulations to minimize and control aggregation.
    • Ensure compliance with USP <787> and <788> subvisible particle requirements.
    • Visualize and classify particle morphology — shape, transparency, aspect ratio, and clustering

⚙️ Product / Instrument Portfolio

FlowCam’s product range includes precision imaging instruments, automation modules, and analytic software for biopharma and life-science workflows.

System Purpose / Functionality
FlowCam 8000 Series Versatile flow imaging microscope for a broad particle-size range — ideal for protein aggregates, excipient particles, and formulation impurities.
FlowCam Nano Specialized for submicron particle imaging (300 nm – ~2 µm) — essential for biologic aggregates, nanoparticles, and LNP characterization.
FlowCam LO Combines flow imaging microscopy + light obscuration to satisfy USP <788> requirements for subvisible particle counting in biopharma QC.
Automation Modules (ALH for FlowCam) Automated liquid-handling and sample-integration module for high-throughput, unattended workflows.
Software (VisualSpreadsheet, VisualAI, Compliance Package) AI-enabled particle classification and regulatory-compliant data reporting with FDA 21 CFR Part 11-ready tools.

FlowCam instruments are advanced flow-imaging-microscopy-based particle analyzers, designed to capture high-resolution images of particles in liquid samples (300 nm – 5 mm) and deliver detailed morphological, concentration, and size data.
They provide image-based insights that go far beyond light-obscuration or laser-diffraction particle counting.

Built for biopharmaceutical, cell, and gene therapy applications, FlowCam helps identify, classify, and control subvisible particles, aggregates, cells, LNPs, and process impurities, as recommended by USP <1788>.

Key Capabilities

    • Identify and quantify subvisible/submicron particles in biologics and nanoparticle formulations.
    • Gain insight into particle sources within formulations to minimize and control aggregation.
    • Ensure compliance with USP <787> and <788> subvisible particle requirements.
    • Visualize and classify particle morphology — shape, transparency, aspect ratio, and clustering

⚙️ Product / Instrument Portfolio

 FlowCam’s product range includes precision imaging instruments, automation modules, and analytic software for biopharma and life-science workflows.

System

Purpose / Functionality

FlowCam 8000 Series

Versatile flow imaging microscope for a broad particle-size range — ideal for protein aggregates, excipient particles, and formulation impurities.

FlowCam Nano

Specialized for submicron particle imaging (300 nm – ~2 µm) — essential for biologic aggregates, nanoparticles, and LNP characterization.

FlowCam LO

Combines flow imaging microscopy + light obscuration to satisfy USP <788> requirements for subvisible particle counting in biopharma QC.

Automation Modules (ALH for FlowCam)

Automated liquid-handling and sample-integration module for high-throughput, unattended workflows.

Software (VisualSpreadsheet, VisualAI, Compliance Package)

AI-enabled particle classification and regulatory-compliant data reporting with FDA 21 CFR Part 11-ready tools.

🎯 Targeted Application Areas & Research Workflows

1️⃣ Biologics Characterisation & Formulation

Monitor and control protein aggregation and formulation impurities in therapeutic proteins.
Applications:

  • Detect and classify protein aggregates and subvisible particles.
  • Visualize morphology to diagnose formulation or process issues.

Verify compliance with USP <787>/<788>.

2. Cell Therapy & Cell-based Products

Characterize viable/non-viable cells, clusters, and debris in manufacturing environments.
Applications:

    • Measure concentrations of single cells, clusters, or debris.
    • Monitor culture growth, morphology, and contamination events.

🔗 Learn more › Cell Therapy

3️⃣ Gene Therapy / Viral & Nanoparticle Delivery Systems

Support LNP, viral vector, and exosome development with quantitative particle analysis.
Applications:

    • Analyze AAV aggregation, LNP particle size, and concentration.
    • Capture morphology and heterogeneity to ensure vector quality and consistency.

🔗 Learn more › Gene Therapy

4️⃣ Drug Formulation & Manufacturing QC

Enable in-line or at-line particle monitoring from development through fill/finish.
Applications:

    • Identify particle sources across manufacturing steps.
    • Compare batches using detailed morphological statistics.
    • Enhance process control and release testing.

🔗 Learn more › Other Biotherapeutics

 

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