Live attenuated varicella vaccine
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Detailed introduction
Product Name: Live Attenuated Varicella Vaccine
National Drug Approval Number S20083005
The live attenuated varicella vaccine developed by Baike Biotechnology uses the WHO-recommended MRC-5 human diploid cell line as the production cell substrate and the WHO-recommended Oka strain of varicella virus as the production viral strain. It also incorporates the company’s proprietary BH-2 lyophilization protectant, which effectively addresses the challenge of maintaining high-titer stability in the varicella vaccine. This product features the following characteristics:
1. Gelatin-free, highly safe
Early international studies have demonstrated that the majority of adverse reactions are associated with gelatin. Our company’s varicella vaccine has successfully eliminated gelatin as an ingredient; compared with gelatin-containing varicella vaccines, our product significantly reduces the incidence of gelatin-induced allergic reactions.
2. High titers, strong protection, and excellent preventive efficacy
Our company’s varicella vaccine manufacturing standard explicitly stipulates that the release criterion for viral titer shall be no less than 4.0 lg PFU per dose, and the viral titer during the shelf life shall be no less than 3.3 lg PFU per dose. Compared with low-titer varicella vaccines, our varicella vaccine can reduce breakthrough cases by nearly 75%.
3. Good stability and long shelf life
Our company’s varicella vaccine is a lyophilized live attenuated varicella vaccine with a 36-month shelf life. The BH-2 stabilizer we employ is protected by proprietary intellectual property rights (Chinese Invention Patent No.: ZL200910138411.6; International Patent Application No.: PCT/CN2009/001405), which significantly enhances the vaccine’s stability and ensures a shelf life of up to 36 months under specified storage conditions.
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