FlowCam - Flow Imaging Microscopy Blog

Austin Daniels

Recent Posts

FlowCam Demonstrates Degradation of Protein Formulations After Transport in IV Bags via Hospital Pneumatic Tube System

Subvisible particles in biotherapeutics represent critical quality attributes because they pose regulatory and potential product safety risks. Therefore, much of the development work behind these therapeutics focuses on creating formulations and manufacturing processes that minimize the particle content in the drug product and reduce the potential for adverse immunogenicity. 

Pictured above are images of IV bags before and after transport via Pneumatic Tube System with Dextrose and Saline.

Despite measures taken during formulation and manufacturing, product quality can still be compromised after manufacturing due to accidental stresses caused by freeze-thawing, exposure to light, and mechanical shock from dropping the drug container. In a recent collaboration between the University of Colorado and Children's Hospital Colorado, researchers investigated particle generation in IV bags containing therapeutic protein formulations in the hospital's pneumatic tube system (PTS). Particle monitoring technologies like FlowCam are critical to ensure biotherapeutics have acceptable particle content not just after manufacturing but up until the therapy is administered to patients.

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Topics: Protein Therapeutics, Biopharmaceutical Research

Characterization of Protein Aggregates and Other Particles in Biopharmaceuticals

Particulates are ubiquitous in parenteral drug products and remain a concern throughout their development and production. These particles must be monitored to satisfy USP particle reporting requirements (e.g. USP <788>). Furthermore, in biopharmaceuticals such as protein therapeutics, these particles have been associated with adverse impacts on the efficacy and safety of the product. FDA regulations strongly recommend in-depth characterization of the quantity and types of particles found in biotherapeutics.

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Topics: Protein Therapeutics, FlowCam Technology, Biopharmaceutical Research