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 positive impacts of therapeutic proteins on the lives of people suffering from cancer, diabetes, multiple sclerosis, Crohn’s disease, ALS, lupus, arthritis and other diseases and conditions have attracted significant investment in drug research and development.

As a result, hundreds of therapeutic protein-based drugs have earned FDA approval, with enormous benefits to human health. With the rapid growth and acceptance of these biologics, more and more information about impacts of product quality on patient outcomes has become available. Based on this growing body of evidence, one of the most important product quality attributes is the concentration and sizes of subvisible particles.

"Lives are on the line when it comes to correct understanding of how therapeutic proteins can form particulate" says Professor John Carpenter, PhD, Professor of  Pharmaceutical Sciences and Co-Director of the Center for Pharmaceutical Biotechnology at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences.

Read the entire article in Laboratory News

Click the infographic on the right to view larger

In microscope systems, it's the numerical aperture (NA) and the wavelength of the light that determine the minimum distance that two particles can be resolved. Clear images, accurate sizing, and consistent categorization all depend on your NA setting.

The 4th Annual European Workshop on Protein Aggregation and Immunogenicity will be held in Salzburg-Wals, Austria on January 28 and 29.  This conference serves as a European summit for thought leaders and academic researchers to come together and discuss the issues of protein aggregation and its effects on the immunogenicity of therapeutic protein drug products. We are excited to attend and exhibit the FlowCam imaging particle analyzer with our German distributor, Anasysta.

Proteins and contaminants from a parenteral drug sample, imaged and analyzed by the FlowCam.

December 2018 — A recent study by researchers from the University of New England and University of New Hampshire has demonstrated that flow imaging microscopy is an accurate, more efficient, and more informative method of elastin-like polymer (ELP) coacervate analysis than standard methods. ELP coacervates are a class of molecules with promising applications in drug delivery vehicles, tissue engineering, environmental remediation, and more. ELP coacervate architecture is stimuli-responsive and highly tunable, making them ideal for the above-mentioned applications.  

The FlowCam continues to be an important instrument in biopharmaceutical research. The ability to image and characterize morphological features of particulate in parenteral formulations is an important aspect of ensuring quality and safety in injectable drug products.

Biopharmaceutical manufacturers strive to ensure patient safety, avoid recalls and protect company reputations. Identifying subvisible particles is an important step in preventing recalls of parenterals. One aspect of product safety is defined in the United States Pharmacopeia (USP) 788 guidelines for particle sizing.  This was designed to control for particles capable of causing capillary occlusion, and therefore focuses on particles larger than 10 µm and 25 µm. As such, no characterization is required for particles below 10 µm. 

We are proud to announce that our FlowCam Nano has earned the Pharmaceutical Manufacturing 2018 Pharma Innovation Award.  Honored in the category of Analytical and Monitoring Devices, the FlowCam Nano particle analyzer is recognized as the industry's first ever flow imaging nano particle analyzer that provides digital images of particles ranging in size from 300 nm to 10+ µm.

Over the years, Fluid Imaging Technologies CEO, Kent Peterson has observed a shift in focus of process components in biopharmaceutical manufacturing from steel and glass to plastic (Single Use Technologies or SUT).  For sure there are advantages and disadvantages of each, from cost to breakage, to formulation interaction and stability.