FIELD: medicine.
SUBSTANCE: group of inventions relates to a method for assessing stability of a protein-based composition comprising a protein, peptide and/or protein derivative and a buffer with respect to the lubricating substance of the lubricated container, which is intended for storage of said composition, including a) assessment of decrease in time of inter-phase tension between buffer and lubricant, b) evaluating the decrease in time of inter-phase tension between the protein-based composition and the lubricant, c) determining at least one protein-based composition component, interacting with the lubricant by comparing the reduction evaluated at step b) with the reduction evaluated at step a), d) based on said determination of at least one component, interacting with a lubricant, determining a risk of instability associated with a buffer or protein, a peptide and/or a protein derivative, a protein-based composition. Group of inventions also relates to a method of improving stability of a protein-based composition with respect to a lubricating substance of a lubricated container, which is intended for storage of said composition.
EFFECT: group of inventions provides assessing the stability of a protein-based composition which includes a protein, peptide and/or protein derivative and a buffer with respect to the lubricant.
7 cl, 1 ex, 10 dwg
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Authors
Dates
2020-09-11—Published
2017-02-10—Filed