Chapter 11: Particles in Biopharmaceuticals: Causes, Characterization, and Strategy
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Publisher
Springer International Publishing
Link
http://link.springer.com/content/pdf/10.1007/978-3-030-31415-6_11
Reference33 articles.
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2. Saggu M, Liu J, Patel A. Identification of subvisible particles in biopharmaceutical formulations using Raman spectroscopy provides insight into polysorbate 20 degradation pathway. Pharm Res. 2015;32(9):2877–88.
3. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJ, Middaugh CR, Winter G, et al. Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality. J Pharm Sci. 2009;98(4):1201–5.
4. Labrenz SR. Ester hydrolysis of polysorbate 80 in mAb drug product: evidence in support of the hypothesized risk after the observation of visible particulate in mAb formulations. J Pharm Sci. 2014;103(8):2268–77.
5. Boll B, Bessa J, Folzer E, Quiroz AR, Schmidt R, Bulau P, et al. Extensive chemical modifications in the primary protein structure of IgG1 subvisible particles are necessary for breaking immune tolerance. Mol Pharm. 2017;14(4):1292–9.
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