Stability of protein pharmaceuticals: an update.
In 1989, Manning, Patel, and Borchardt wrote a review of protein stability (Manning et al., Pharm. Res. 6:903-918, 1989), which has been widely referenced ever since. At the time, recombinant protein therapy was still in its infancy. This review summarizes the advances that have been made since then regarding protein stabilization and formulation. In addition to a discussion of the current understanding of chemical and physical instability, sections are included on stabilization in aqueous solution and the dried state, the use of chemical modification and mutagenesis to improve stability, and the interrelationship between chemical and physical instability.
Manning
Mark Cornell
MC
Legacy BioDesign LLC, Johnstown, Colorado 80534, USA. manning@legacybiodesign.com
Chou
Danny K
DK
Murphy
Brian M
BM
Payne
Robert W
RW
Katayama
Derrick S
DS
D000818:Animals; D004355:Drug Stability; D006801:Humans; D004364:Pharmaceutical Preparations / Q000737:chemistry* / Q000378:metabolism*; D055550:Protein Stability; D011506:Proteins / Q000737:chemistry* / Q000378:metabolism*
D004364:Pharmaceutical Preparations; D011506:Proteins