Specific Anti-IIa Activity is a Key Indicator of Safety and Efficacy in Validation of Biosimilarity of Unfractioned Heparin Preparations

Миронов, А Н; Goryachev, D. V.; Garvishina, E. V.; Niyazov, R.R.; Ivanova, O. Yu.

doi:10.1007/s10517-015-2782-3

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2018

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“…Anti-IIa assays are then the right methods for measuring the anti-thrombin activity of large heparin molecules [10]. The Heparin Anti-IIa method is a two-stage method based on the inhibition of a constant amount of Thrombin (IIa), by the tested heparin in presence of exogenous antithrombin, then hydrolysis of a Thrombin specific chromogenic substrate, by Thrombin in excess.…”

Section: Introductionmentioning

confidence: 99%

Heparin Sodium Was Prepared from Pig Intestinal Mucosa by Dialysis and Spray Drying

Shu¹,

Mei²,

Yang³

et al. 2018

JBM

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A method to extract crude heparin sodium from pig intestinal mucosa by dialysis and spray drying was established. The pig intestinal mucosa was treated in the following steps: enzymolysis, resin exchange adsorption-washing, elution, pressure filtration, dialysis, spray drying. Activity of the product was measured using a heparin anti-IIa factor assay kit. The yield of crude heparin obtained by this method was 2.79% higher than that of oven drying method; the production of 1 kg crude heparin sodium saved 43.4 pigs small intestine. The activity was 98.48 ± 2.49 IU/mg (n = 5), 15.18 IU/mg higher than that obtained by oven drying method. The product is pale white powder, attractive color and easy to dissolve.

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Section: Introductionmentioning

confidence: 99%