Zagorodnia J.A.,PrJSC Biopharma |
Skrynnyk M.M.,PrJSC Biopharma |
Tymchenko A.S.,SIInstitute of Haematology and Transfusiology AMS Ukraine |
Kovalev R.N.,PrJSC Biopharma |
And 3 more authors.
Russian Journal of Biopharmaceuticals
A new immunoglobulin preparation for intravenous administration BIOVEN has been elaborated. It satisfies the most recent international quality and safety regulations. Due to chromatographic purification in mild conditions, the preparation possesses a high Fc-function activity and low impurities content. A high stability of 10 % solution allows room temperature storage up to two years. The processing technology includes validated virus inactivation stages, particularly solvent/detergent. The immunoglobulin yield is 5 g from 1 l of plasma. Source