Home News

Why is it not of animal origin? —Rotavirus

Certification
China Shanghai Yaxin Biotechnology Co.,Ltd. certification
China Shanghai Yaxin Biotechnology Co.,Ltd. certification
Customer Reviews
Although we are first cooperation, your company left a very deep impression on me. You are a very honest company.

—— Jim Holf

Thank you very much. Your products are very good. Next time I will continue to buy. It is worth to recommend the company.

—— Susan Vird

I'm Online Chat Now
Company News
Why is it not of animal origin? —Rotavirus
Latest company news about Why is it not of animal origin? —Rotavirus

    Rotavirus-infected diarrhea is the second leading cause of emergency and death (except respiratory infections) in infants and young children. There is currently no effective treatment. Rotavirus vaccine is the most cost-effective way to prevent rotavirus infection. In the quality control of vaccines, exogenous factors are important detection indicators. In 2010, both RotarixR and RotaTeqR produced by GlaxoSmithKline and Merck's two major vaccine manufacturers have detected the foreign factor-porcine circovirus (PCV). This is after the intussusception event, the safety of rotavirus vaccines has once again become the focus of attention in the health field. Focus issues arising from this incident include safety issues such as the source of PCV DNA, whether PCV is pathogenic to humans, whether there are complete PCV DNA sequences and virus-like particles in the vaccine, and whether it can cause human infection after oral vaccine. GSK speculates that it is derived from pig-derived pancreatic enzymes used for cell passage. Trypsin is a commonly used raw material in the preparation of vaccine cell matrices, which has caused more confusion about the safety of vaccines produced using cell matrices. At the same time, recognized detection methods and standards need to continue to be improved.

 

    In the past ten years, domestic, European, and Indian recombinant insulin, vaccine research and development, and stem cell culture companies have successively switched to recombinant trypsin. The Chinese Pharmacopoeia Commission also commissioned Shanghai Yaxin Biotechnology Co., Ltd. to launch the 2020 Chinese Pharmacopoeia For the formulation of recombinant trypsin standards, Shanghai Yaxin is the contractor for formulating the 2020 version of the recombinant trypsin pharmacopoeia standards, and is also the national supplier of recombinant trypsin standards. Recombinant pig trypsin is produced by recombinant E. coli expression, and its amino acid sequence is completely the same as that of pig pancreas-derived trypsin. It has the same enzymatic properties as animal-derived pig trypsin, and can replace pig pancreas-derived trypsin in various organisms. Technical process.

latest company news about Why is it not of animal origin? —Rotavirus  0

    In March 2010, Victoria et al. Used metagenomics and microbial genomics technologies to administer oral polio vaccine, rubella virus vaccine, measles virus vaccine, yellow fever virus vaccine, chickenpox virus vaccine, two rotavirus vaccines, and Testing of 8 live attenuated vaccines, including the combined measles rubella epidemic mumps vaccine, found type 1 swine rings in Rotarix, a Rotavirus (RV) vaccine produced by GlaxoSmithKline (GSK) A DNA fragment of a virus (Porcine circovirus, PCV). At the same time, the FDA released news on March 22, 2010 that an exogenous virus component was detected in Rotarix, and therefore it is recommended to temporarily suspend the use of the vaccine.

 

1. Rotavirus vaccine and porcine circovirus

 

    Rotavirus vaccines that have been approved for marketing globally include Rotarix of GlaxoSmithKline (GSK), RotaTeq of Merck, and a live attenuated rotavirus vaccine (Lanzhou lamb) produced by Lanzhou Biological Products Research Institute Co., Ltd. rotavirus vaccine (LLR) is only used in China. The three types of rotavirus vaccines are sold in large quantities and used in a wide range of areas. Therefore, the vaccine has a wide range of social impacts and potential safety risks.

 

PCV is a non-enveloped, single-stranded circular DNA virus that is an icosahedron with a diameter of about 20 nm and a genome size of about 1760 nt. It includes two major open reading frames (ORFs). PCV was first discovered in passaged porcine kidney cells (PK-15). PCV is divided into two types, PCV1 and PCV2. The pathogenicity of PCV2 is only 76%, but the genome structure is very similar. PCV antibodies can be detected in a variety of mammals, including humans, mice, cattle, and pigs, but the pathogenicity of PCV to these animals has not been determined.

 

2. Detection and Response Principles of PCV

 

    The FDA has taken proactive steps to respond to the emergency. After suspending the use of Rotarix, it is recommended that the Merck company in the United States screen its rotavirus vaccine RotaTeq. Preliminary results show the presence of porcine circovirus type 1 and type 2 DNA fragments in RotaTeq (the vaccine solution was detected by 20-fold concentration (The DNA fragment unit content of PCV in the stock solution is close to the detection limit), and this result has also been confirmed by the FDA. After collecting more information and conducting internal experiments, on May 7, 2010, the FDA met with the Vaccines and Related Biological Products Advisory Committee to discuss the contamination incident. The meeting introduced the background of the accidental detection of PCV, concluded that there is no evidence that PCV is pathogenic to humans, and discussed the risks and countermeasures caused by the presence of PCV on the use of Rotarix and RotaTeq. The detection of PCV1 (not only for PCV1) also indicates that the existing traditional detection technology can no longer meet the needs of biological product testing. For the analysis and detection of cell media, virus strains and other biological materials used in the production of human virus vaccines, there are some advanced analytical methods that have not yet been applied, and the meeting also made recommendations for the practical application of these methods. On May 14, 2010, the FDA updated the follow-up report on the incident, changing the recommendation to “suspend Rotarix” to “recommend clinical re-use of Rotarix and continue to use RotaTeq”. There are three reasons for the amendment:

    ① Both GSK and Merck have good safety records and have conducted a large number of clinical trials;

    ② There is no evidence that PCV can cause harm to human safety;

    ③ The benefits of using rotavirus vaccines are much higher than the existence of PCV and the theoretical potential harm.

    FDA and manufacturers will continue to investigate and evaluate the test results of all parties. In China, after the National Institutes for Food and Drug Control (NIFDC) learned of the incident, the PCV detection technology was established and improved in a timely manner, and the 2 batches of Rotarix and RotaTeq registered for registration and testing were tested. It also proved the existence of PCV1 DNA in Rotarix. At the invitation of WHO, NIFDC experts went to Baltimore, Maryland, USA on May 18, 2011 to participate in the revised WHO expert guidelines on risk assessment after the discovery of contamination by exogenous factors in biological products (draft), and made a report entitled " A special report on the status of detection and control of exogenous factors in biological products in China. From May 19th to May 21st, he was invited to participate in the academic seminar on new technologies and risk assessment of exogenous factor detection convened by the International Alliance for Biological Standardization (IABS).

 

3. Recombinant trypsin replaces animal-derived trypsin for use in biopharmaceuticals

 

    In the past ten years, domestic, European, and Indian recombinant insulin, vaccine research and development, and stem cell culture companies have successively switched to recombinant trypsin. The Chinese Pharmacopoeia Commission also commissioned Shanghai Yaxin Biotechnology Co., Ltd. to launch the 2020 Chinese Pharmacopoeia For the formulation of recombinant trypsin standards, Shanghai Yaxin is the contractor for formulating the 2020 version of the recombinant trypsin pharmacopoeia standards, and is also the national supplier of recombinant trypsin standards. Recombinant pig trypsin is produced by recombinant E. coli expression, and its amino acid sequence is completely the same as that of pig pancreas-derived trypsin. It has the same enzymatic properties as animal-derived pig trypsin, and can replace pig pancreas-derived trypsin in various organisms. Technical process.

Pub Time : 2019-12-05 14:16:03 >> News list
Contact Details
Shanghai Yaxin Biotechnology Co.,Ltd.

Contact Person: Mr. zhao

Tel: +86-21-54336492

Fax: 86-21-54336593

Send your inquiry directly to us (0 / 3000)