Biotechnology Bulletin ›› 2014, Vol. 0 ›› Issue (11): 219-224.

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Preparation and Analysis of Lyophilization Characterization of Human D-dimer

Wu Jianwei ,Cai Lei ,Wang Jihua, Tang Shixing   

  1. National Engineering Laboratory of Rapid Diagnostic Test, Guangzhou Wondfo Biotech Co., Ltd., Guangzhou 510663
  • Received:2014-05-12 Online:2014-11-07 Published:2014-11-07

Abstract: D-dimer is formed by sequential action of 3 enzymes from fibrinogen. After producing D-dimer, we did the research on its lyophilization process. To produce cross-linked fibrin, fibrinogen was digested by thrombin and Factor XIIa. Then, fibrin degradation products(FDP)was prepared from cross-linked fibrin being degraded by plasmin. D-dimer was purified from FDP through ultrafiltration and prepared into lyophilized powder. By optimizing the lyophilization program, lyophilized D-dimer was stable for at least 12 days at 37℃, stable for at least 8 days at 25℃ and 30 days at 4℃ after reconstitution, and not different when being dissolved by different solvent.The preparation system established in this research is feasible and efficient. Depend on its stability, lyophilized D-dimer could be provided as biological raw materials for further research.

Key words: Fibrin , Fibrinogen , D-dimer, Thrombus , Lyophilized power