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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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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Assessing subvisible particle content is a required quality control step for biotherapeutics and other parenteral drug products. The United States …
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Optimizing FlowCam context settings and instrument parameters used during particle analysis is an important step in developing a protocol for …
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Beginning October 22nd, the American Association of Pharmaceutical Scientists (AAPS) will welcome attendees to PharmSci 360 - an annual gathering of …
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Effective strategies for monitoring particles in biotherapeutics are critical to meet regulatory requirements like USP <788> and mitigate the …
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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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Monitoring particles in biotherapeutics during manufacturing is critical to ensure product quality and to meet regulatory requirements on particle …
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Comprehensive characterization of biotherapeutics is often challenging given their complexity. In many cases, singular analytical methods cannot …
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Flow Imaging Microscopy (FIM) has emerged as an essential tool and an increasingly common approach in analytical labs for the quantification and …
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In a recent paper from Rostock University Medical Center, authors Anja Kurzhals et al. summarize a study they performed to determine the relevant …
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Many new types of biotherapeutic Active Pharmaceutical Ingredients (API) such as viruses, nanomedicines including virus-like particles and lipid …
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