FlowCam® - Flow Imaging Microscopy Blog

New Tools and Opportunities in Subvisible Particle Analysis

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.

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Topics: Protein Therapeutics, FlowCam Technology, Biopharmaceutical Research, Nanoparticles

Machine Learning Helps Characterize Antibody Aggregation Using FlowCam (Flow Microscopy) Images

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.

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Topics: Protein Therapeutics, FlowCam Technology, Biopharmaceutical Research

Flow Imaging Microscopy (FIM) Coupled with Convolutional Neural Networks (CNN) Demonstrates Reliable Method to Characterize and Identify Impurities in Cell Based Medicinal Products (CBMPs)

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.

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Topics: Protein Therapeutics, FlowCam Technology, Biopharmaceutical Research

Insight Into the FlowCam's Role in India's Biopharmaceutical Market

Yokogawa Fluid Imaging Technologies' distributor to India's Biopharmaceutical market is Bioscreen InstrumentsBioscreen's Field Application Specialist, Jamuna Yadhav, shared with us the following testimonial and case study about their experience using the FlowCam to analyze injectable drug samples.

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Topics: Protein Therapeutics, FlowCam Technology, User Spotlight, Biopharmaceutical Research

VisualSpreadsheet and 21 CFR Part 11 Compliance: Meeting Regulatory Requirements with the FlowCam

VisualSpreadsheet 5 image analysis software (ViSp 5) represents a new platform for FlowCam data organization. Introduced in 2019, our upgraded software moves away from a simple hierarchy of folders and instead utilizes a database structure.

Biopharma labs working in drug development will be excited to learn about the module for fully-integrated compliance with 21 CFR Part 11 regulations mandated by the US FDA.

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Topics: Protein Therapeutics, FlowCam Technology, Biopharmaceutical Research

U-Medico Uses FlowCam to Assess Drug Stability Using Tapered Needles vs. Cylindrical Needles

Injectable biopharmaceuticals, particularly prefilled syringes (PFS), come with risks related to the force of injection, such as patient pain and anxiety. The injection force can often be especially high with PFSs, due to the high viscosity of the contained substances.

"In clinical practice, injection pressure is commonly estimated by the injection force, which is a measure of effort required by the user during depression of the plunger on a delivery device. Previous studies have suggested that low exerted injection force was consistent with improved patient convenience and ease of injection."

Terumo Corporation has recently developed a tapered injection needle in the hopes that it will reduce the force of injection and improve the patient experience.

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Topics: Protein Therapeutics, Biopharmaceutical Research

West Pharma Uses FlowCam for Early Drug Development

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.

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Topics: Protein Therapeutics, Biopharmaceutical Research

Our Most Popular Blog Posts of 2019

We use our Flow Imaging Microscopy blog as a platform to bring you relevant news and academic research, as well as highlighting developments and new uses of FlowCam technology. This year we published 68 blog posts on a large variety of subjects. Keep reading to see the countdown to the most popular post of 2019.

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Topics: Industrial Applications, Protein Therapeutics, Marine Research, News and Events, Harmful Algal Blooms, FlowCam Technology, Aquatic Research, Biopharmaceutical Research

Flow Imaging Microscopy Reveals Particles Missed by DLS and NTA

The problem of protein aggregation and presence of extrinsic particles in biopharmaceutical formulations is not a small one. With the improvement of particle analysis technologies, developers are discovering that drug impurities and protein aggregation occur at multiple phases of formulation development, production, and quality control. The goal is to ensure the production of pure and safe biologics that can be shipped and delivered to patients, ensuring their health and safety. 

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Topics: Protein Therapeutics, Biopharmaceutical Research

FlowCam can assess effects of mechanical stress (aggregation) on protein formulations in syringes resulting from hospital transportation systems.

University of Colorado PhD student, Vaida Linkuviene, along with Fluid Imaging Applications Scientist, Heather Anne Wright, and Co-Director of the Center for Pharmaceutical Biotechnology at the University of Colorado, John Carpenter, recently presented a poster at the 2019 Colorado Protein Stability Conference, at which Fluid Imaging has long been a participant. Vaida has been working with the FlowCam to assess the effects mechanical stress on protein formulations in syringes.

Pictured here: Vaida with her poster "Effects of transportation of syringes containing protein formulations through a hospital pneumatic tube system: Particle characterization by multiple methods"

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Topics: Protein Therapeutics, User Spotlight, Biopharmaceutical Research