Formulation development and primary degradation pathways for recombinant human nerve growth factor.

摘要: The chemical and physical stabilities of recombinant human nerve growth factor (NGF) in aqueous solution were investigated between 5 37 °C at pH 4.2−5.8. NGF stability decreased with a decrease due to Asp60-Pro61 cleavage, the being greater acetate buffer than succinate each investigated. Aggregation was significant degradation pathway °C, aggregation rate greatest 5.8. Quantitation by cation-exchange chromatography complicated rearrangement monomer variants into various mixed dimers over time. Treatment dilute acid brought dimer distribution rapidly equilibrium, allowing be accurately quantitated. An acetate-buffered formulation 5.5 more detail. To assist product identification, accelerated base, hydrogen peroxide, temperature. These products s...