Biopharma
Analyze Subvisible Particles per USP Recommendations
Particle content is a critical quality attribute for many biologics that must be monitored to meet regulatory requirements like USP <788> and mitigate product safety risks.
Flow imaging microscopy is an established technique recommended by USP <1788> for subvisible and submicron particle analysis, revealing particle count, size, and shape, indicating their type and source.
Monitor the aggregation of adjuvants, nano-drug delivery systems, and other small particles to larger, potentially concerning, submicron and subvisible particles.
Use FlowCam to:
- Detect aggregation and agglomeration of the active pharmaceutical ingredient (API) and drug delivery vehicles to improve product stability
- Obtain images and particle morphology information not obtainable from orthogonal techniques to assess product degradation
- Differentiate between inherent particles, intrinsic particles like glass flakes and silicone oil droplets, and extrinsic contaminants
- Optimize and control particulates in your formulation
“There is great value in seeing images of the particles and of the actual contaminants. It allows us to identify particle type and particle source via morphology, which increases the strength of the finding.”
FlowCam images of particles in a biotherapeutic sample, including protein aggregates, silicone oil droplets, fibers, and other contaminants
A FlowCam collage of hydrogel microspheres
A FlowCam collage of Dynabeads
FlowCam – A Flexible Particle Analysis Solution
Apply flow imaging microscopy techniques to therapeutics including aggregates of drug delivery systems like liposomes, exosomes, and gold nanoparticles, and vaccine components like virus-like particles and adjuvants.
FlowCam is ideally suited to analyze samples containing larger particles like CHO cells, cell cultures and associated particles like Dynabeads™ and Tentagel™ beads, and hydrogel spheres.
Obtain size and morphology information of these particles that is related to product quality issues such as cell viability, misshapen drug delivery vehicles, and the form of any aggregates present.
- Improving vaccine formulations by monitoring API and adjuvant aggregation
- Characterizing large liposome, exosome, and other drug delivery platform morphology with an automated microscopy technique
- Optimizing cell concentrations and viability during biotherapeutic manufacturing
- Observing Dynabead binding and measuring unbound bead concentrations in cell culture applications
Additional Resources
Guides
- Ultimate Guide to Flow Imaging Microscopy for Biotherapeutics
- Imaging Organoids with FlowCam - An important step in advancing disease modeling and novel therapeutic drug screening
- Monitoring Subvisible Particles in Therapeutic Drug Products
- What are the USP <787>, USP <788>, and USP <789> Standards?
Product Brochures
White Papers
- Orthogonal and Complementary Techniques: Combining FIM with LO to Characterize Biotherapeutics
- Measuring Subvisible Particles and Aggregates Using FlowCam LO
- Early Detection of Aggregation in Formulations: FlowCam Nano for submicron particle characterization in biotherapeutics
Webinars
Videos
Published Research
- FlowCam Provides Visualization of Lycopodium Plant Sporoderm Microcapsule Degradation
- Dandelion Pollen: A Promising Drug Delivery and Microencapsulation Vehicle
- New High-Throughput Method for Elastin-like Polymer (ELP) Coacervate Analysis
Blog Posts
- What are the USP <787>, USP <788>, and USP <789> Standards?
- What Does "Orthogonal Method" Mean for Particle Analysis?
- How to Meet USP Requirements and Recommendations for Subvisible Particulate Matter with FlowCam LO
- Identifying Bacterial Contamination in FlowCam Samples
- Preventing Embolism from Active Implantable Medical Devices
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