Yunnan Wosen Biotechnology Co.

Kunming, China

Yunnan Wosen Biotechnology Co.

Kunming, China
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Fan H.-L.,Yunnan Wosen Biotechnology Co. | Wu K.,Yunnan Wosen Biotechnology Co. | Zhang S.-X.,Yunnan Wosen Biotechnology Co. | Chen L.,Yunnan Wosen Biotechnology Co. | And 7 more authors.
Chinese Journal of Biologicals | Year: 2014

Objective: To establish a method for determination of polysaccharide content in freeze-dried groups A, C, Y and W135 meningococcal polysaccharide conjugate vaccine. Methods: Ten containers of freeze-dried groups A, C, Y and W135 meningococcal polysaccharide conjugate vaccine were reconstituted with water for injection, and divided into ten aliquots, 70 μl for each, then added with 0, 1, 2, 3, 4, 5, 6, 7, 8 and 9 μl of 20 mg/ml protease K respectively to degrade the carrier protein, and determined for polysaccharide content by rocket Immunoelectrophoresis, based on which the dosage of protease K was optimized. The developed method was determined for linear range, quantitative limit and verified for accuracy, precision and specificity. Results: The optimal dosage of protease K was 5 μl. The linear range and quantitative limit of the developed method were 2.5 ~ 40 μ.g/ml and 2.5 μg/ml respectively. The mean recovery rates of groups A, C, Y and W135 polysaccharide in test samples at three concentrations in three repeat tests were 99.1%, 96.5%, 96.5% and 97.4% respectively. The CVs of groups A, C, Y and W135 polysaccharide contents in the same test sample determined for 9 times by various personnel at various time points were 3.40%, 4.11%, 3. 35% and 4.88% respectively. The polysaccharide antigens of various groups showed immunoprecipitation with the antisera of the corresponding groups, while showed no immunoprecipitation with those of other groups, indicating a high specificity of the method. Conclusion: A method for determination of polysaccharide content in freeze-dried groups A, C, Y and W135 meningococcal polysaccharide conjugate vaccine was established, which showed high accuracy, precision and specificity within the defined linear range.

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