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β-glucan as a Process-Related Impurity in Biopharmaceuticals
Global regulatory authorities and #CDMOs are taking steps to detect beta-glucans as well as understand their safety levels. When introduced into biopharma drug products via raw materials in the manufacturing process, beta-glucan impurities can lead to batch recalls and other quality issues. In this whitepaper, Soonbin Kwon, our Senior Scientist in MSAT, explores the source of the beta-glucan impurity, its influence on manufacturing and patient safety, and strategies to detect and control its amounts in the final drug product.
Global regulatory authorities and #CDMOs are taking steps to detect beta-glucans as well as understand their safety levels. When introduced into biopharma drug products via raw materials in the manufacturing process, beta-glucan impurities can lead to batch recalls and other quality issues. In this whitepaper, Soonbin Kwon, our Senior Scientist in MSAT, explores the source of the beta-glucan impurity, its influence on manufacturing and patient safety, and strategies to detect and control its amounts in the final drug product.