Pharmaceutical Research

, Volume 27, Issue 4, pp 544–575 | Cite as

Stability of Protein Pharmaceuticals: An Update

  • Mark Cornell Manning
  • Danny K. Chou
  • Brian M. Murphy
  • Robert W. Payne
  • Derrick S. Katayama
Expert Review


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.


formulation protein stability protein stabilization 



The assistance of Gabe Evans with the reference formatting and proofreading is gratefully appreciated.


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Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  • Mark Cornell Manning
    • 1
  • Danny K. Chou
    • 2
  • Brian M. Murphy
    • 1
  • Robert W. Payne
    • 1
  • Derrick S. Katayama
    • 3
  1. 1.Legacy BioDesign LLCJohnstownUSA
  2. 2.GenzymeFraminghamUSA
  3. 3.Amylin PharmaceuticalsSan DiegoUSA

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