Effective strategies for monitoring particles in biotherapeutics are critical to meet regulatory requirements like USP <788> and mitigate the …
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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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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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Silicone oil has long been used in the pharmaceutical industry as a lubricant for syringes. It serves to reduce the force necessary to depress the …
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Injectable biopharmaceuticals, particularly prefilled syringes (PFS), come with risks related to the force of injection, such as patient pain and …
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Cardiovascular implants, such as drug coated balloons or drug eluting stents used to treat coronary artery disease are subject to rigorous testing …
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Plant sporoderm are among the most robust biomaterials in nature. The spore/pollen cell material can be easily extracted leaving an excellent natural …
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