High purity and quality Hualan Biological Recombinant Hepatitis B Vaccine (Hansenula polymorpha)

Recombinant Hepatitis B Vaccine (Hansenula polymorpha)

Recombinant Hepatitis B Vaccine (Hansenula polymorpha)

Package insert of Recombinant Hepatitis B Vaccine (Hansenula polymorpha)

• Description
• Advantage
• Instructions
• Related Products

Original strain of recombinant Hansenula constructed by the recombinant DNA technology is used for the preparation of Hualan Hepatitis B Vaccine (Hansenula) and the strain number is RBHG-14. The strain is prepared by inserting surface antigen genes of hepatitis B in the promoter carrier of methanol oxidase and integrating the carrier into the genome of Hansenula. It is the most stable strain with the largest quantity of antigen genes of hepatitis B integrated among the similar strains.

RBHG-14 genome contains at least 30 copied surface antigen genes, which makes high density fermentation and high level expression possible. Expression efficiency of the unit culture solution is high, 10 times that of saccharomyces cerevisiae and 40-50 times that of CHO cells, and has few impurities, which provides a good foundation for the good quality of products.

Fermentation of bacterial strains adopts inorganic salt medium which has a higher safety performance, lower impurity and milder side effects. Adopt the Germany Automatic Fermentation System to make the manufacturing more stable and difference between batches smaller. After the cultivation of Hansenula is over, adopt the imported High Pressure Homogeniser to break cells so as to make the complex surface antigen of hepatitis B fully released and the environmental become softer. In this way, the completeness and stability of surface antigen are guaranteed as well as the output.

Adopt internationally advanced purification process to obtain bulk with high purity by means of making cell breakage solution with rich surface antigen of hepatitis B pass through the affinity chromatography, anion exchange chromatography and molecular sieve chromatography successively. The process is highly efficient and the environmental variation is soft compared with other methods, which makes the minimum loss of antigen during the purification so as to improve the purity and stability of final product.

Thimerosal has been added during the manufacturing or in final product as preservative and stabilizer since the 1930s. For the hepatitis B vaccine, Hualan solved problems of bacterial infection and instability of vaccine via closed and automatic channelization manufacturing and study of vaccine adjuvant so as to avoid harms on human bodies, especially infants caused by the thimerosal.

During the traditional production of vaccines, addition of antibiotics during manufacturing or in final products can prevent bacteria growing. Hualan ensures that hepatitis B vaccines with high purity and quality can still be manufactured without antibiotics via strict quality control so as to avoid abnormal reactions in individuals because of the allergy to antibiotics.

Formaldehyde was used as an inactivator in the traditional production and its micro scale residue may cause adverse reactions, e.g.: local redness and swelling in injection site, etc. No formaldehyde is added during the manufacturing of hepatitis B vaccine of Hualan,

therefore, the injection is safer and the incidence of adverse reactions is lower.

In order to guarantee the quality of product during the vaccine transportation, Hualan has established transit logistics stations in Beijing, Suzhou, Chongqing and Guangzhou and equipped dozens of refrigerator cars. All those cars adopt the GPS Management System of Cold-chain Transportation developed by the GLP Software Management Company in USA to realize the monitoring of temperature and location of product at any time during the transportation; thereby make sure products can be sent to the destination as soon as possible, enlarge the market share of our products and make clients have more confidence in our products.

Package insert of Recombinant Hepatitis B Vaccine (Hansenula polymorpha)

[Drug Name]

Generic Name: Recombinant Hepatitis B Vaccine (Hansenula polymorpha)

English Name: Recombinant Hepatitis B Vaccine (Hansenula polymorpha)

Chinese Pinyin: Chongzu Yixing Ganyan Yimiao (Hanxun Jiaomu)

[Constituents and Characters]

The vaccine is a preparation of purified hepatitis B surface antigen(HBsAg),expressed by the recombinant hansenula polymorpha. After purification an aluminum adjuvant is added to the purified HBsAg for adsorption. The vaccine is a milky-white suspension with a slight precipitate which can be dispersed on shaking.

Active ingredients: hepatitis B surface antigen (HBsAg)

Excipients: NaOH, crystalline AlCl3, Na2HPO4, NaH2PO4 and NaCl.

[Vaccination Subjects] The subject aged 5 years and above susceptible to hepatitis B virus, particularly for the health care personnel or the laboratory workers handling human blood.

[Function and Use] The product can induce immunity against hepatitis B virus in recipients following immunization. It is used to prevent hepatitis B.

[Specifications] 0.5 ml per container.0.5 ml per single human dose containing 10μg of HBsAg.

[Administration and Dosages]

(1) Intramuscularly inject the vaccine in the region of the deltoid muscle of the upper arm.

(2) Three injections are required for a complete immunization course at the schedule of 0, 1st and 6th months. Single dose of 0.5 ml for each person, containing 10 μg of HBsAg.

[Adverse Reactions]

Common adverse reactions:

Pain and tenderness at the injection site may appear in a few people within 24 hours after vaccination. Normally it will disappear in two or three days.

Rare adverse reactions:

(1) Transient fever may appear within 72 hours after vaccination. Normally it lasts 1～2 days and will vanish without treatment.

(2) Mild and moderate pain and swelling may appear at injection site and will be relieved spontaneously within 1～2 days without treatment.

Very rare adverse reactions:

(1) Indurations at injection site may appear, and will be absorbed within 1～2 months.

(2) Local aseptic suppuration: The pus should be pumped out repeatedly with syringes. If serious, debridement should be given to remove necrotic tissues. It will last a longer time, but will eventually heal.

(3) Anaphylaxis: Allergic rash and Arthur reaction. Arthur reaction generally occurs within 10 days after vaccination, with reddish swelling at local site lasting a long time. Sterols may be used for systemic and/or local treatment.

(4) Anaphylactic shock: generally occurs within 1 hour after vaccination. Adrenaline should be given timely for treatment.

[Contraindications]

(1) People with known hypersensitivity reactions to any components of the vaccine, including yeast and excipients.

(2) People who have acute illness, severe chronic diseases, acute exacerbation of chronic disease and fever.

(3) Pregnant women.

(4) People with uncontrolled epilepsy or other progressive neurologic disorders.

[Precautions]

(1) The vaccine should be given with caution in inpiduals with a history of convulsions, chronic disease, epilepsy, or allergies.

(2) Shake the container well before use. Do not use the vaccine if any foreign matter or the clump not dispersed on shaking, leakage of vial, illegible label are found.

(3) Administer immediately once opened.

(4) Adrenaline should be available for first aid in case of severe anaphylactic reactions. The vaccinees shall take a rest for at least 30 minutes on site following immunization.

(5) If abnormal conditions such as high fever or convulsion occur after the first injection, the second injection should not be given.

(6) Do not freeze.

[Storage] Store and ship at 2-8°C, protected from light.

[Packaging]10µg/0.5ml/vial, 3 vials per carton, packaged by colorless glass tubing vial and brominated butyl rubber stopper.

[Shelf Life]36 months.

[Product Standard] YBS00522011 and Chinese Pharmacopoeia (2015) Volume III

[Product License No.]GYZZ S20100008

[Manufacturer]

Hualan Biological Bacterin Co., Ltd.
Address: Jia No.1-1, Hualan Ave., Xinxiang, Henan, China
Tel: 86-373-3559991

Fax: 86-373-3559911

Mail: hualan@hualanbio.com