The effect of mAb and excipient cryoconcentration on long-term frozen storage stability – Part 1: Higher molecular weight species and subvisible particle formation-Reference-Cited by-同舟云学术

The effect of mAb and excipient cryoconcentration on long-term frozen storage stability – Part 1: Higher molecular weight species and subvisible particle formation

Published:2022-12 Issue: Volume:4 Page:100108
ISSN:2590-1567
Container-title:International Journal of Pharmaceutics: X
language:en
Short-container-title:International Journal of Pharmaceutics: X

Author:

Bluemel Oliver,Anuschek Moritz,Buecheler Jakob W.,Hoelzl Georg,Bechtold-Peters Karoline,Friess Wolfgang

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference39 articles.

1. Physical stability of drugs after storage above and below the glass transition temperature: Relationship to glass-forming ability;Alhalaweh;Int. J. Pharmaceut.,2015

2. The ice-water interface and protein stability: a review;Arsiccio;J. Pharm. Sci.,2020

3. Heightened cold-denaturation of proteins at the ice–water interface;Arsiccio;J. Am. Chem. Soc.,2020

4. Freezing of biologicals revisited: scale, stability, excipients, and degradation stresses;Authelin;J. Pharm. Sci.,2020

5. Subvisible particle counting provides a sensitive method of detecting and quantifying aggregation of monoclonal antibody caused by freeze-thawing: insights into the roles of particles in the protein aggregation pathway;Barnard;J. Pharm. Sci.,2011

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