Phase-Appropriate Application of Analytical Methods to Monitor Subvisible Particles Across the Biotherapeutic Drug Product Life Cycle-Reference-Cited by-同舟云学术

Phase-Appropriate Application of Analytical Methods to Monitor Subvisible Particles Across the Biotherapeutic Drug Product Life Cycle

Published:2019-10-30 Issue:1 Volume:22 Page:
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Mathaes Roman,Narhi Linda,Hawe Andrea,Matter Anja,Bechtold-Peters Karoline,Kenrick Sophia,Kar Sambit,Laskina Olga,Carpenter John,Cavicchi Richard,Koepf Ellen,Lewis E. Neil,De Silva Rukman,Ripple Dean

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1208/s12248-019-0384-0.pdf

Reference23 articles.

1. Corvari V, et al. Subvisible (2–100 μm) particle analysis during biotherapeutic drug product development: part 2, experience with the application of subvisible particle analysis. Biologicals. 2015;43(6):457–73.

2. Singh SK, et al. An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics. J Pharm Sci. 2010;99(8):3302–21.

3. Narhi LO, et al. A critical review of analytical methods for subvisible and visible particles. Curr Pharm Biotechnol. 2009;10(4):373–81.

4. Zölls S, et al. Particles in therapeutic protein formulations, part 1: overview of analytical methods. J Pharm Sci. 2012;101(3):914–35.

5. Joubert MK, et al. Classification and characterization of therapeutic antibody aggregates. J Biol Chem. 2011: p. jbc;M110:160457.

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