FlowCam^® - Flow Imaging Microscopy Blog

Characterization of subvisible particles in protein therapeutics has become an increasingly important means to ensure the development of safe, stable, and effective medicines.  Many analytical techniques are available to identify and prevent not only protein aggregation, but to fulfill regulatory requirements. The purpose of this study by Danny Chou, President and Founder of Compassion BioSolution, LLC is to compare different techniques and their ability to identify subvisible particles and what relationship exists between the number of particles and different stress conditions imposed upon the protein drug products.

Flow Imaging Microscopy has been widely implemented for the analysis of particles ranging in size from 1-10µm. Yet, in recent years the FDA has highlighted the need for better analytical tools to fully understand how different stress conditions can impact the stability of the formulation. While light obscuration and membrane microscopy have been the primary methods to conduct USP testing for particles between 10µm - 25µm, regulators are now moving towards expecting orthogonal analytical methods to characterize and provide quantitative data on particles in the 2µm - 10µm range as well.

FlowCam Nano offers the ability to image and analyze particles ranging from 30µm down to as small as 300 nm.

The team at the University of Colorado, Boulder have long been FlowCam customers, most recently incorporating FlowCam images with artificial intelligence, in the form of convolutional neural networks, to characterize and identify impurities in protein therapeutics and cell based medicines.

Hunting Energy Services (HES), Subsea Technologies Division, is a manufacturer of subsea hydraulic products for the oil and gas industry. Their suite of hydraulic valve products includes applications for drilling control, production control, and Intervention Workover Control Systems (IWOCS).

Yokogawa Fluid Imaging Technologies announced this week the release of its newest FlowCam with a fully integrated light obscuration module. By combining industry-standard light obscuration technology required for USP compliance with digital images from proven Flow Imaging Microscopy (FIM) technology, the new FlowCam + LO will soon become the preferred instrument in biopharma labs worldwide.

The Anderson (Chemistry) and Brehm-Stecher (Food Science) groups at Iowa State University have been awarded a FlowCam Research Equipment and Travel Grant from Yokogawa Fluid Imaging Technologies (YFT) for use in their ongoing research on microbiological applications of Magnetic Ionic Liquids (MILs).

Cell-based medicinal products (CBMPs) are gaining importance as therapeutic treatments for many life-threatening diseases. This study was designed to develop a method to characterize CBMPs using flow imaging microscopy (FIM) for the detection, quantification, and characterization of subvisible particulate impurities.  Recently, FIM has been applied to study cell viability and confluency in cell culture as well as quality of CBMPs. Comprehensive particle characterization can be limited when using the morphological parameters derived from the embedded software due to the complexity of CBMPs, which may consist of multiple particulate populations of highly heterogeneous morphologies.

We are excited to announce that on April 8th, Fluid Imaging Technologies was acquired by Yokogawa Electric Corporation of Tokyo, Japan.

As FIT joins the Yokogawa Group, Yokogawa will be able to expand its portfolio of cell observation and particle analysis solutions offered by its life innovation business, and thereby strengthen its business targeting the bioeconomy market.

West Pharmaceutical Laboratories (Exton, PA) recently published a paper on a streamlined bioanalytical approach to determine the most appropriate primary container system early in drug development. Given the importance of monitoring biological drug and container interactions to ensure drug and patient safety, it is necessary to consider multiple variables when determining drug packaging systems.

Nick Ray (PhD Candidate) and Gretchen McCarthy (Senior) from the Boston University Marine Program (BUMP) came to visit our FlowCam lab in Scarborough this week. Nick Ray had used a FlowCam in 2016 in Dr. Robinson Fulweiler's lab when he was a recipient of our Student Equipment Grant. Gretchen has worked in this lab since she was a freshman. She's planning to begin graduate school next year and will focus her studies on fisheries and aquaculture.

High-performance liquid chromatographyis a technique in analytical chemistry used to separate, identify, and quantify each component in a mixture. It relies on pumps that pass a pressurized liquid solvent containing the sample mixture through a column filled with a solid adsorbent material. Each component in the sample interacts slightly differently with the adsorbent material, causing different flow rates for the different components and leading to the separation of the components as they flow out of the column.