THE APPLICATION OF ANALYTICAL METHODS AND MODEL SYSTEMS IN THE LYOPHILIZATION OF COMPLEX BIOMOLECULES

摘要

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.rnMany of these preparations have multi-component formulations and over recent years we 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 our experiences in these areas will be shared.rnThe presentation will be illustrated by reference to both model systems and processed standards which have enabled us to arrive at a rational approach to the challenges of manufacturing such a wide range of lyophilized reference materials.