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. 2012 Fall;11(4):1087-93.

Biological activity analysis of native and recombinant streptokinase using clot lysis and chromogenic substrate assay

Arash Mahboubi  1 , Seyyed Kazem Sadjady, Mohammad Mirzaei Saleh Abadi, Saeed Azadi, Roya Solaimanian
Affiliations

Biological activity analysis of native and recombinant streptokinase using clot lysis and chromogenic substrate assay

Arash Mahboubi et al. Iran J Pharm Res. 2012 Fall.

Abstract

DETERMINATION OF STREPTOKINASE ACTIVITY IS USUALLY ACCOMPLISHED THROUGH TWO ASSAY METHODS: a) Clot lysis, b) Chromogenic substrate assay. In this study the biological activity of two streptokinase products, namely Streptase®, which is a native product and Heberkinasa®, which is a recombinant product, was determined against the third international reference standard using the two forementioned assay methods. The results indicated that whilst the activity of Streptase® was found to be 101 ± 4% and 97 ± 5% of the label claim with Clot lysis and Chromogenic substrate assay respectively, for Heberkinasa® the potency values obtained were 42 ± 5% and 92.5 ± 2% of the label claim respectively. To shed some light on the reason for this finding, the n-terminal sequence of the streptokinase molecules present in the two products was determined. The results showed slight differences in the amino acid sequence of the recombinant product in comparison to the native one at the amino terminus. This finding supports those of other workers who found that n-terminal sequence of the streptokinase molecule can have significant effect on the activity of this protein.

Keywords: Biological activity; Chromogenic substrate; Clot lysis; Native streptokinase; Recombinant streptokinase.

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Figures

Figure 1
Figure 1
The streptokinase products activity assessed by fibrin-clot and chromogenic methods. Analysis of biological activity of native and recombinant streptokinase using Clot lysis and Chromogenic substrate assay
Figure 2
Figure 2
Native PAGE analysis of two streptokinase products. Lane (A) Heberkinasa® Lane (B) Streptase®.Analysis of biological activity of native and recombinant streptokinase using Clot lysis and Chromogenic substrate assay
Figure 3
Figure 3
Densitometric comparison of two preparations on native gel stained with coomassie blue. (A) Heberkinasa®, (B) Streptase® Analysis of biological activity of native and recombinant streptokinase using Clot lysis and Chromogenic substrate assay
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