scientist in lab using pipetter with USP
What are the Recommendations in USP <1787> and <1788>?
Subvisible particles (those 2-100 μm in diameter) in protein, cell, and gene therapies and other parenteral drug products pose risks to the safety …
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What are the USP <787>, USP <788>, and USP <789> Standards?
All biotherapeutics contain particulate matter which, as defined by the United States Pharmacopeia (USP), refers to mobile undissolved particles that …
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Scientists in lab with test tubes, looking at data on monitor
What Does "Orthogonal Method" Mean for Particle Analysis?
Comprehensive characterization of biotherapeutics is often challenging given their complexity. In many cases, singular analytical methods cannot …
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Biopharma particles with a variety of capture settings
FlowCam Capture Settings for Biopharmaceutical Applications
Scientists using FlowCam in biopharmaceutical research need to accurately assess many diverse particle types that may be present in their samples. …
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Scientist working in biopharmaceutical lab using pipettor
Webinar: Flow Imaging Microscopy for Subvisible Particle Analysis in Biotherapeutics
Strategies for monitoring subvisible particles in biopharmaceutical formulations are central to developing and manufacturing safe, effective drug …
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Scientist's hand using pipettor
How to Meet USP Requirements and Recommendations for Subvisible Particulate Matter with FlowCam LO
Assessing subvisible particle content is a required quality control step for biotherapeutics and other parenteral drug products. The United States …
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Scientist pipetting sample into rack of vials
How to Analyze Subvisible Particles in Protein, Cell & Gene Therapies
All types of biotherapeutics, ranging from protein therapies to cell and gene therapies, contain particles. While the types of particles can vary …
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Stock photo of e. coli bacteria under microscope
Identifying Bacterial Contamination in FlowCam Samples
One of the main values of using flow imaging microscopy (FIM) when analyzing pharmaceuticals is the method's sensitivity to transparent particles. …
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Scientist working in lab using pipettor
Optimizing Your FlowCam Context Settings: New Research Available
Optimizing FlowCam context settings and instrument parameters used during particle analysis is an important step in developing a protocol for …
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Graphic advertising AAPS PharmSci 360, with an Exhibitor badge
Learning Opportunities Abound at AAPS 2023 PharmSci 360
Beginning October 22nd, the American Association of Pharmaceutical Scientists (AAPS) will welcome attendees to PharmSci 360 - an annual gathering of …
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Woman scientist in lab using pipettor, with the word
Flow Imaging Microscopy for Subvisible Particle Analysis: A Webinar
Effective strategies for monitoring particles in biotherapeutics are critical to meet regulatory requirements like USP <788> and mitigate the …
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AAPS eChalk Talks graphic
Orthogonal & Complementary Techniques: An Introductory Webinar
A central challenge with particle analysis in biotherapeutics is the wide size range of particles that may be present. Particles in these samples can …
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