IIR document

The application of analytical methods and model systems in the lyophilization of complex biomolecules.

Author(s) : MATEJTSCHUK P., MALIK K. P., DURU C., et al.

Summary

NIBSC produces primary biological reference materials from a wide range of sources, including sera, cell culture, purified proteins, nucleic acids and carbohydrates, and from complex preparations including viral lysates and cellular materials. Most of these standards are lyophilized to provide assured stability over a shelf life of many years. Many of these preparations have multi-component formulations and over recent years, the authors have applied a wide range of analytical methods to determine the critical thermal transitions and eutectic properties. Low residual moisture and controlled container properties are also essential to maintain this prolonged storage stability and the authors' experiences in these areas is shared. The presentation is illustrated by reference to both model systems and processed standards which have enabled them to arrive at a rational approach to the challenges of manufacturing such a wide range of lyophilized reference materials.

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Pages: 2007-3

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Details

  • Original title: The application of analytical methods and model systems in the lyophilization of complex biomolecules.
  • Record ID : 2008-2754
  • Languages: English
  • Source: New Ventures in Freeze-Drying
  • Publication date: 2007/07

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