Comprehensive characterization of biotherapeutics is often challenging, given their complexity. In many cases, singular analytical methods cannot …
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Lipid nanoparticles (LNPs) are a type of nanocarrier with immense potential, serving as a tool to deliver nucleic acids like messenger RNA (mRNA) and …
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The risk of embolism, caused by particulate matter shed from medical device delivery systems, is a growing concern in the medical field. Ensuring …
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Pharmaceutical researchers face mounting pressure to track and control particles in their drug formulations throughout development. Strategies to …
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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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All biotherapeutics contain particulate matter, defined by the United States Pharmacopeia (USP) as mobile undissolved particles that are …
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Adeno-associated viruses (AAVs) have shown promise as vectors for gene therapy due to their non-pathogenic nature and effective infectivity for a …
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The protein aggregate content in protein therapies and other biological drug products is often a critical quality attribute that must be monitored. …
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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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Protein aggregates in protein therapies can be difficult to monitor and measure in protein formulations due to their high transparency and irregular …
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Strategies for monitoring subvisible particles in biopharmaceutical formulations are central to developing and manufacturing safe, effective drug …
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Assessing subvisible particle content is a required quality control step for biotherapeutics and other parenteral drug products. The United States …
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