FlowCam® - Flow Imaging Microscopy Blog

FlowCam, Flow Imaging Microscopy and Machine Learning Methods, Applications for Particle Morphology Analysis

Imagine being able to identify specific problems in a formulation simply by analyzing the particles and composition of protein aggregates present in a sample?  The delicate nature and limited stability of protein therapeutics means that virtually all protein formulations contain particles resulting from routine processes, stresses and varied aggregation sources. Monitoring and managing protein aggregates and other particulates in therapeutic formulations is essential to mitigating the risk of adverse responses that could result from these particles. 

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Topics: Protein Therapeutics, FlowCam Technology, Biopharmaceutical Research

FlowCam Reveals Silicone Oil Droplets and Other Particulates in Intravitreal Injections (IVIs)

Silicone oil has long been used in the pharmaceutical industry as a lubricant for syringes. It serves to reduce the force necessary to depress the plunger, and can make procedures more comfortable and safer for the doctor and patient as it allows the needle to slide more easily through the eye wall.

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Topics: Protein Therapeutics, Biopharmaceutical Research

Detecting Subvisible Particles in Protein Therapeutics

Last week, The-Scientist.com introduced their new Research Products blog. Their very first post discusses the capabilities of the FlowCam Nano:

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

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