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Zhang J.,Wuhu Kangwei Biotechnology Co. | Weng L.,Wuhu Kangwei Biotechnology Co. | Zou X.,Wuhu Kangwei Biotechnology Co. | Li J.-X.,Wuhu Kangwei Biotechnology Co. | And 7 more authors.
Chinese Journal of Biologicals | Year: 2015

Objective: To optimize the procedure for lyophilization of of oral recombinant Helicobacter pylori vaccine so as to decrease the breakage rate of containers during lyophilization. Methods: Twelve batches of oral recombinant H. pylori vaccine were subjected to lyophilization test by changing the technological parameters at steps of pre-freezing, sublimation drying and dehydration drying, and the procedure for lyophilization was optimized using the breakage rate of containers based on the qualifications of appearance, moisture content, pH value and sterility. Results: The procedure for lyophilization of oral recombinant H. pylori vaccine was optimized as follows: The vaccine was frozen to -45 °C within 2 h and maintained for 4. 5 h at step of pre-freezing, then subjected to periodic warming for 34 h at step of sublimation drying, and was maintained at 28 °C for 12 h at step of dehydration drying. The appearance, moisture content, pH value and sterility of the oral recombinant H. pylori vaccine were within the acceptable range, while the breakage rate of containers was zero. Conclusion: The optimized procedure for lyophilization of oral recombinant H. pylori vaccine was stable and reliable, which laid a foundation of large-scale production in future. Source

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