Analyzing Subvisible Particles and Cells in Biotherapeutics

Monitoring particles in biotherapeutics is critical to assess product quality, meet regulatory guidelines, and ensure product safety and efficacy. Often, flow imaging microscopy (FIM) is used to measure the concentration, sizes, and morphologies of subvisible particles in biotherapeutics. 

Learn more about FlowCam for:

Protein Therapeutics   |   Viral Vectors   |   Nanomedicine   |   Cells

Flow Imaging microscopy is a highly sensitive, orthogonal technique to light obscuration to analyze translucent particles per USP <1788>. The high-quality microscopic images of particles help identify and control particle sources to maximize the quality of drug products from development to manufacturing. Learn more about how flow imaging microscopy can work alongside other complementary and orthogonal analytical particle monitoring techniques by watching our recent webinar.

Watch Webinar


FlowCam, a flow imaging microscope, is used in the development of many biotherapeutic platforms from traditional protein-based biologics to advanced therapies. Learn more below about how FlowCam can help you optimize your biotherapeutic formulation and stability.

Close up of syringe pulling vaccine from vial

Protein Therapeutics

Protein aggregates are ubiquitous in protein-based drug products and have been associated with adverse reactions in the clinic. FlowCam allows researchers to differentiate these aggregates from other common inherent, intrinsic, and extrinsic subvisible particles like silicone oil, degraded polysorbate, and glass flakes from each other.

Thumbnail - FlowCam white paper

Our white paper, "Characterizing Protein Aggregation with Orthogonal and Complementary Analytical Techniques", describes how flow imaging microscopy using FlowCam LO and FlowCam Nano is combined with other analytical techniques such as light obscuration and dynamic light scattering to characterize protein aggregation in protein formulations.

Download White Paper

Thumbnail - FlowCam white paper

Another white paper demonstrates how FlowCam images can discriminate between particle types in protein formulations and, specifically, use artificial intelligence software such as VisualAI to differentiate between subvisible protein aggregates and silicone oil droplets.

Advanced Biologics

Treatments that use viral vectors such as AAVs and lentiviruses, cells, nucleic acids like mRNA, and other biological agents as the active pharmaceutical ingredient (API) have shown promise as the next generation of biotherapeutics. FlowCam provides particle information that can help address the unique challenges in developing each of these modalities.

Viral Vectors

Like protein-based therapies, viral vectors will generate aggregates over time and may result in subvisible particles that pose product quality concerns. A recent report describes the importance of monitoring particles like these in viral vector samples.

Read the Report

FlowCam offers flexible sample volume requirements, providing particle detection and source information with small sample aliquots as well as robust, statistically significant particle quantification with larger volumes. Obtain appropriate information about viral vector aggregation and other particles throughout viral vector formulation development and manufacturing using a single protocol with as little or as much sample volume as is available.

Nanomedicine

Lipid nanoparticles (LNPs), liposomes, exosomes, and other drug delivery vehicles are of interest to researchers due to the success of the COVID-19 vaccines built on this platform. FlowCam can be used to monitor the stability of nanomedicines in a formulation and potentially detect the smallest aggregates these vehicles can form, allowing researchers to diagnose product stability issues as soon as they occur. 

Download our Application Note

Doctor holding tweezers, overlaid by rendering of DNA

Cells

FlowCam is a powerful cell analysis platform combining the imaging capabilities of light microscopy with the throughput of flow cytometry. The instrument allows users to rapidly determine cell concentrations and, as shown by Grabarek et al., label-free assessment of cell viability with flow imaging.

Read the Study

Flow imaging can also help identify contaminants like cellular debris and residual Dynabeads, allowing researchers to identify and differentiate these hard-to-remove particulate contaminants and eliminate them at the source.

Interested in learning more?

  1. Get in Touch

    Tell us about your application and particle characterization needs.

  2. Have a conversation

    We're happy to set up a call to discuss your application and answer your questions.

  3. Discuss next steps

    Expand your knowledge with a seminar, demonstration, sample analysis, or obtain a quote.

Get in Touch