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Updated: Jan 26, 2026
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Analysis of β-Amyloid-induced Abnormalities on Fibrin Clot Structure by Spectroscopy and Scanning Electron Microscopy
Published on: November 30, 2018
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Analysis of inline-filter blockage with trastuzumab formulation using scanning-electron microscopy
Chiaki Ogawa1, Motoki Inoue2, Megumi Yatabe3
1Department of Pharmacy, National Hospital Organization Tokyo Medical Center, 2-5-1 Higashigaoka, Meguro-ku, Tokyo 152-8902, Japan; Laboratory of Pharmaceutics, Kitasato University School of Pharmacy, 5-9-1 Shirokane, Minato-ku, Tokyo 108-8641, Japan.
Summary
Vigorous shaking during pharmaceutical monoclonal antibody preparation can cause protein precipitation and filter blockage. Rapid preparation procedures are crucial to prevent precipitate formation and ensure patient safety.
Area of Science:
- Biopharmaceutical science
- Protein chemistry
- Clinical pharmacy
Background:
- Pharmaceutical monoclonal antibodies are susceptible to physical stimuli, leading to instability.
- Precipitation during monoclonal antibody preparation can cause filter blockade, impacting patient care.
- Understanding precipitation mechanisms is vital for improving drug administration.
Purpose of the Study:
- To investigate the mechanisms behind filter blockade during trastuzumab preparation.
- To identify factors contributing to protein precipitation in monoclonal antibody solutions.
- To provide insights for optimizing preparation protocols.
Main Methods:
- Monoclonal antibody samples (trastuzumab) were prepared under clinical conditions.
- Precipitate formation was induced by vigorous shaking and subsequent incubation.
- Precipitates were comprehensively observed and identified.
Main Results:
- Vigorous shaking induced protein precipitation due to surfactant-mediated foam formation and air contact.
- Precipitates were identified as proteins, causing filter blockade.
- Precipitation occurred after samples were shaken and left for several hours.
Conclusions:
- External stimuli, such as vigorous shaking, can destabilize monoclonal antibody preparations.
- Foam formation and surfactant activity play a key role in protein precipitation.
- Minimizing preparation time and avoiding vigorous agitation are essential to prevent precipitate formation.
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