FlowCam - Flow Imaging Microscopy Blog

Detection of Subvisible Particulates in Bioformulations to Ensure Safety

NIST protein standards imaged on the FlowCam Nano at 40XBiopharmaceutical 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. 

Read More

Topics: Protein Therapeutics, Biopharmaceutical Research, Nanoparticles

Technological Advances Push Protein and Particulate Research Further: Insights from the 2018 Workshop on Protein Aggregation and Immunogenicity

KentPetersonCEOFluidImagingTechnologiesKent Peterson is the CEO of Fluid Imaging Technologies.

Every summer, around 160 researchers converge at the Workshop on Protein Aggregation and Immunogenicity hosted in Breckenridge, Colorado by the University of Colorado Center for Pharmaceutical Technology and the AAPS Focus Group on Protein Aggregation and Immunogenicity. 

At the Workshop, scientists studying the behavior, formation, and effects of protein aggregates and other subvisible particles in therapeutic formulations gather to present their research and discuss industry issues.

Read More

Topics: Protein Therapeutics, News and Events, FlowCam Technology, User Spotlight, Biopharmaceutical Research

Japanese Consortium Assesses the Standardization of Flow Imaging Microscopy for Therapeutic Protein Regulations

In a recent study by Kiyoshi et al., a Japanese consortium conducted a collaborative study to assess the standardization of flow imaging microscopy (FIM) for the analysis of subvisible particles (SVPs) and protein aggregates in therapeutic protein products.

Read More

Topics: Protein Therapeutics, User Spotlight, Biopharmaceutical Research

Sub-visible dangers of plastic; nanoparticles in biopharmaceutical devices

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.

Read More

Topics: Protein Therapeutics, Biopharmaceutical Research, Nanoparticles

FlowCam Nano Wins Excellence Award at Pittcon 2018


Ten leading edge companies were recognized Tuesday, February 27th with Pittcon Today Excellence Awards at the annual Pittcon Conference and Expo in Orlando, Florida. The award is delivered to new products recognized for ingenuity and innovation in laboratory science.

Fluid Imaging Technologies received the Silver award for the FlowCam Nano and it's Nano-Flow Imaging™ capability.

Pictured at left: Kent Peterson, CEO Fluid Imaging Technologies, Inc. at Pittcon 2018. 

Read More

Topics: Protein Therapeutics, FlowCam Technology, Biopharmaceutical Research

New Flow Imaging Nanoparticle Analyzer Provides Early Warning System of Colloidal Activity for Formulation Scientists

Fluid Imaging to Unveil FlowCam® Nano at Pittcon Booth #1628

Formulation scientists start out with relatively particle free solutions.  Instability may cause precipitation of dissolved matter into colloidal matter. Therefore, the goal of formulation development is to create a stable formulation.  The new FlowCam® provides the submicron images necessary to function as an early warning system of colloidal activity and its origins (protein or silicon oil). The real-time images are invaluable in the identification of the origins of protein aggregation.

Read More

Topics: Protein Therapeutics, FlowCam Technology, Biopharmaceutical Research

PepTalk 2018 - Observations

PepTalk 2018 was held again this January in San Diego, CA with a full week of technical talks, short courses, poster presentations and exhibits. While my perspective centers on protein molecule formulations, I do intersect the industry downstream, where instrumentation is tasked with characterizing drug formulations.

Read More

Topics: Protein Therapeutics, Biopharmaceutical Research

Fluid Imaging Technologies Introduces First Ever Nano-Flow Imaging™ Particle Analyzer

New FlowCam® Nano Ends Biopharmaceutical Dark Ages, Begins Enlightenment.

Scarborough, ME: For the first time ever, Nano-Flow particle imaging provides digital images of particles ranging in size from 300nm to 30µm using patented, oil immersion technology for enhanced optical resolution. The new FlowCam® Nano from global laboratory instrumentation manufacturer Fluid Imaging Technologies, Scarborough, ME (www.fluidimaging.com) is the world’s only flow imaging nano particle analyzer.

Read More

Topics: Protein Therapeutics, News and Events, FlowCam Technology, Biopharmaceutical Research

Overcoming Nonhomogeneity: How to Analyze Subvisible Particles that Range in Size with Flow Imaging

The most common method for characterizing subvisible particles (SVP) ranging in size from 10µm to 100µm is light obscuration (LO). 

"LO, however, has a major drawback—an inability to assess morphology and thus differentiate between particles of various natures, air bubbles, silicon oil droplets, nonprotein particles, and protein aggregates." (Levin et al., 2015). 

Imaged proteins  captured by FlowCam from Levin et al. (2015). "Particles in this aliquot were very well detected by the FlowCam (Fig. 1), indicating excellent optical resolution of the instrument. Image fragmentation.... was a relatively rare event" Levin et al. (2015). 

Read More

Topics: Protein Therapeutics, Biopharmaceutical Research

Imaging Particle Analysis Reveals Higher Concentrations of Sub-Visible Particles Compared to Light Obscuration Technique

Omontys® – a brand name peginesatide injectable – was voluntarily withdrawn from the market less than a year after the product launch. Clinical trials had demonstrated the drug to be safe and efficacious, but over 40 cases of anaphylaxis, and 7 fatalities were reported soon after the product was introduced to the market.

Peginesatide, a man-made form of erythropoietin, is used to treat anemia in people with chronic kidney disease treated with dialysis. Those suffering from kidney failure may have reduced amounts of erythropoietin in their body. 

A recent article in the Journal of Pharmaceutical Sciences (JPS)1 discussed how the U.S. Food and Drug Administration (FDA) task force investigated the Omontys events with several particle analyzers, including the FlowCam®.

Read More

Topics: Protein Therapeutics, FlowCam Technology, Biopharmaceutical Research