Biopharma
FlowCam for Protein Aggregate Analysis in Therapeutics Development
Discover a high-throughput flow imaging microscopy platform for characterizing API aggregates and other particulates in your protein, monoclonal antibody, or antibody-drug conjugate formulation.
Monitor your formulation for protein aggregates, intrinsic particles including silicone oil, degraded polysorbate, and glass flakes, as well as extrinsic contaminants.
FlowCam provides quality assurance for your parenteral drug product to give you peace of mind about the stability and safety of your formulation.
Use FlowCam to:
- Count and size protein aggregates as small as 300 nm with industry-leading image quality
- Obtain complementary particle image data recommended by USP <1788> to verify orthogonal particle size measurements by light obscuration
- Utilize image-based analytics including artificial intelligence tools to classify subvisible and submicron particles
“With FlowCam we get to see the particle morphology instead of just counts, and that really helps facilitate the debugging process if we encounter any issues during the development of new products.”
A FlowCam collage of common particles in therapeutic protein formulations including protein aggregates, silicone oil droplets, and polysorbate particles.
The FlowCam family of products for biopharmaceutical applications: FlowCam 8100, FlowCam Nano, FlowCam LO
VisualSpreadsheet software interface showing protein aggregates automatically identified with VisualAI artificial intelligence.
FlowCam Provides Confidence in Protein Formulation Quality
Capture high-resolution images for the identification of particle type, allowing you to detect and mitigate undesirable and potentially harmful particle formation at the source.
Improve formulation design based on protein aggregate analysis using FlowCam in accelerated protein stability studies.
- Use FlowCam LO to obtain USP <787> compendial particle sizing information and images in a single instrument in quality control monitoring
- Improve lab productivity and data reproducibility with ALH for FlowCam automated liquid handling.
- Employ VisualAI™ to classify images of protein biotherapeutics automatically with higher than 90% accuracy
Additional Resources
Guides
- Ultimate Guide to Flow Imaging Microscopy for Biotherapeutics
- What's the Value of Monitoring Silicone Oil Droplets in Protein Therapeutics?
- Identifying Bacterial Contamination in FlowCam Samples
Blog Posts
- FlowCam: Why is Protein Aggregate Analysis Important During Formulation Development?
- What are the USP <787>, USP <788>, and USP <789> Standards?
- What Does "Orthogonal Method" Mean for Particle Analysis?
- How to Analyze Subvisible Particles in Protein, Cell & Gene Therapies
- How to Meet USP Requirements and Recommendations for Subvisible Particulate Matter with FlowCam LO
White Papers
- Orthogonal and Complementary Techniques: Combining FIM with LO to Characterize Biotherapeutics
- Robust AI Methods for Protein Biotherapeutics: VisualAI Software for Sample-Agnostic Image Analysis with FlowCam
- Characterizing Protein Aggregation With Orthogonal and Complementary Analytical Techniques
- Early Detection of Aggregation in Formulations: FlowCam Nano for submicron particle characterization in biotherapeutic formulations
Case Studies
Published Research
- Top FlowCam Studies for Biopharmaceuticals
- FlowCam Bibliography
- Developing Improved Protein-Like Particle Standards for Subvisible and Visible Particle Analysis
- Monitoring Subvisible Particle Formation in Infusion Bags Exposed to Stress Conditions
- Study from Osaka University Compares FlowCam, MFI, and iSpect Data
Videos and Webinars
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