Products
Recombinant Hepatitis B Vaccine with Yeast
AIM Honesty Biopharmaceutical Co., Ltd. is a reliable vaccine manufacturer. Its self-developed RECVAX® Recombinant Hepatitis B Vaccine with Yeast utilizes a domestically pioneering and internationally leading recombinant Hansenula polymorpha yeast expression technology platform and patented adjuvant technology. Its immune efficacy even surpasses that of imported products at the same dosage, as well as various domestically produced products at different dosages.
You can confidently choose AIM Honesty Biopharmaceutical Co., Ltd. as your hepatitis B vaccine manufacturer and supplier. We possess comprehensive production and research and development capabilities. Our Recombinant Hepatitis B Vaccine with Yeast is manufactured by purifying the hepatitis B virus surface antigen (HBsAg) expressed by recombinant Hansenula polymorpha yeast and then adding aluminum hydroxide adjuvant.
Product Specification
Compared to other technical routes, RECVAX® were produced with a more rigorous pharmacopeia standard, which improve the quality and safety of the product.
| Pharmacopoeia Item | Endotoxin content | Free formaldehyde | Thiocyanate | Residual amount of antibiotics | Residual amount of bovine serum albumin |
| Hansenula polymorpha | Less than 5 EU/ml | Less than 15 µg/ml | Not applicable | Not applicable | Not applicable |
| Saccharomyces cerevisiae | Less than 5 EU/ml | Less than 20 µg/ml | Should be less than 1 µg/ml | Not applicable | Not applicable |
| CHO cells | Less than 10 EU/ml | Less than 50 µg/ml | Not applicable | No more than 50 ng/dose | No more than 50 ng/dose |
| Process | Hansenula Yeast | Saccharomyces Yeast | CHO Cell |
| Process Description | Most advanced process | First generation yeast expression system | Most dated process |
| Tumorigenic Risk? | No | No | Yes |
| Antibiotic Added? | No | No | Yes |
| Bovine Serum Albumin Added? | No | No | Yes |
| Animal Pathogen Risk? | No | No | Yes |
| Thiocyanate Added? | No | Yes | No |
| Immunogenicity | High | Higher | Not much (general double dose vs. yeast shows poor response) |
| Vaccine Purity | Highest | Higher | More additives, lower purity |
| Potential Benefit | Strongest cellular immunity induction | Second strongest cellular immunity induction | Weakest cellular immunity induction |
| Representative Product Statement | 10 µg applicable to all populations | 10 µg applicable only to children | 10 µg immunogenicity poor, almost discontinued |
Product Features and Applications
The RECVAX® series vaccines utilize patented adjuvant technology, employing in-situ adsorption technology. Upon entering the body, it forms an antigen reservoir, continuously releasing antigens, extending the duration of action, thereby enhancing the immune response and improving immunogenicity.
The Recombinant Hepatitis B Vaccine with Yeast has been on the market for 20 years and has been used in 31 provinces, municipalities, and autonomous regions in China, with a cumulative usage of nearly 500 million doses, providing immunization solutions for nearly 80% of newborns in China.
A study led by Academician Li Lanjuan evaluated the booster immunization effect of four different hepatitis B vaccines in children aged 5 to 15 years. After receiving a booster dose of 10 μg RECVAX® (Hansenula polymorpha) vaccine using the 0-1-6 month schedule, the anti-HBs seropositivity rates at 1, 5, and 8 years after the booster immunization all reached 83.4%, the highest among all four vaccines.
Precautions
(1) The hepatitis B vaccine should be used with caution in individuals with a family or personal history of convulsions, a history of chronic diseases, a history of epilepsy, or those with allergic constitutions.
(2) The vaccine should be shaken well before use. Do not use if there are undissolved clumps, foreign matter, a broken vial, or an unclear label.
(3) The vaccine should be used immediately after opening the vial.
(4) Adrenaline and other medications should be available for emergency use in case of a severe allergic reaction. Recipients should be observed on-site for at least 30 minutes after vaccination.
(5) If high fever, convulsions, or other abnormal reactions occur after the first vaccination, a second vaccination should generally not be given; for infants receiving mother-to-child transmission prevention, the second and third vaccinations should be given according to the doctor's instructions.
(6) Freezing is strictly prohibited.
Production Details
Professional and modern production workshops are the cornerstone of high-quality products!
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● 26F, T6, Dazu Square, NO.2 Ronghua South Road, ETDZ, Beijing, China
● 10F, Port Building, 1 Fenghe Road, Pudong, Shanghai, China -
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