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Stability and Characterization of Recombinant Human Relaxin

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Formulation, Characterization, and Stability of Protein Drugs: Case Histories

Part of the book series: Pharmaceutical Biotechnology ((PBIO,volume 9))

Conclusions

Relaxin was discovered more than 50 years ago. However, only with the advent of recombinant DNA technology have sufficient amounts of human relaxin been produced and made available for in-depth biochemical characterization and pharmacological studies. These investigations have characterized the solution and stability behavior of this hormone. In particular, degradation routes and conditions for formulation as a liquid for systemic administration or gel-based formulations for local application have been established. Pharmacological studies of human relaxin have identified the involvement of relaxin in many physiological processes, ranging from collagenolysis, inhibition of myometrial contraction, enhancement of sperm motility, to its effect of the cardiovascular system leading to lowering of blood pressure. However, the differences in relaxin activities among the different animal models have led to some contradictory observations. Thus, the full elucidation of the biology of this important human hormone lags behind the understanding of its biochemical and stability behavior. Human parturition involves a temporal sequence of events and interplay between different hormones and effector molecules (Porter, 1983; Sortino et al., 1989). It is very likely that a successful clinical application of this protein will require additional knowledge of when in the parturition cycle rhR1x should be given, how often, and in what combination with other molecules that are normally produced during labor and delivery. Not until the biology of rhR1x in humans is thoroughly understood, will it be possible to design proper human clinical trials that will demonstrate the therapeutic value of this protein.

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  1. Department of Pharmaceutical Research and Development, Genentech, Inc., South San Francisco, California, 94080, USA

    Tue H. Nguyen & Steven J. Shire

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  1. Tue H. Nguyen
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  1. Megabios Corporation, Burlingame, California, USA

    Rodney Pearlman

  2. Scios Nova, Inc., Mountain View, California, USA

    Y. John Wang

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Nguyen, T.H., Shire, S.J. (2002). Stability and Characterization of Recombinant Human Relaxin. In: Pearlman, R., Wang, Y.J. (eds) Formulation, Characterization, and Stability of Protein Drugs: Case Histories. Pharmaceutical Biotechnology, vol 9. Springer, Boston, MA. https://doi.org/10.1007/0-306-47452-2_5

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  • DOI: https://doi.org/10.1007/0-306-47452-2_5

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