FlowCam - Flow Imaging Microscopy Blog

Geometry can play a crucial role in the performance of fibers in different applications. Shape factors that influence performance include length (i.e. size of the longest dimension of the fiber), width (i.e. size of the shortest dimension), and curl. Despite the importance of fiber geometry, many conventional particle sizing measurements struggle to accurately capture the morphology of these particles.

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.”

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.

We're excited to announce the release of VisualAI^TM 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.

Utilizing proper capture settings during image acquisition is crucial to obtaining accurate concentration and sizing data with FlowCam. Distance to nearest neighbor (DNN) is an important capture setting that specifies the distance (in µm) required between two particles for them to be imaged separately. Properly optimizing DNN ensures that only one complete particle is captured per image.  

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.

FlowCam 8000 series instruments provide count and concentration data for a wide variety of fluid samples. Relative counts can be compared reliably among different samples, while concentrations provide particles/mL values based on the actual fluid volume imaged by the instrument. By understanding and considering the various factors that can affect reported concentrations, FlowCam users can ensure they are obtaining accurate concentration data.

The new ALH for FlowCam^TM 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. 

Particles are ubiquitous in biotherapeutics and can drastically impact the efficacy of a given drug. Therefore, characterizing them is a critical step in biotherapeutic development, both to ensure samples meet particle limits set by regulations like USP <787/788>, and to maximize the safety and efficacy of the therapeutic.

New, innovative technologies may help researchers working with these therapies better understand the particles in their samples and, in turn, make more informed decisions about a sample’s quality. 

In a recent paper from Rostock University Medical Center, authors Anja Kurzhals et al. summarize a study they performed to determine the relevant morphological characteristics of particulates shed by a commercially available coronary stent delivery system. Flow Imaging Microscopy (FIM), also called Dynamic Image Analysis (DIA), was used to image and analyze particles produced during a simulated implantation of the cardiovascular device.