FlowCam - Flow Imaging Microscopy Blog

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

Machine Learning Technology May Help Doctors Identify and Treat Blood Infections in Newborns More Quickly

New research using machine learning technology may help doctors identify pathogens in blood samples in a fraction of the time of current methods, leading to faster deployments of life-saving treatments in patients suffering from sepsis, especially newborns.

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Topics: News and Events, FlowCam Technology, Biopharmaceutical Research

FlowCam Identifies Transparent Particles Shedding from Medical Devices

Cardiovascular implants, such as drug coated balloons or drug eluting stents used to treat coronary artery disease are subject to rigorous testing for safety. The assessment of particles released from such devices is essential in the approval of these types of coated medical devices because particles released into the blood stream can increase the risk of emboli. In this study the FlowCam was used to count and analyze particles collected during simulated tests, and these results were compared to light obscuration particle counting.
Pictured at right, FlowCam images with different threshold values.

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Topics: News and Events, FlowCam Technology, 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

Therapeutic Proteins Can Save Lives: Nano-Flow Imaging Helps Make These Drugs Safer

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

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Topics: Protein Therapeutics, Biopharmaceutical Research, Nanoparticles