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    Home > Active Ingredient News > Drugs Articles > Domestic new crown vaccine is expected to be listed by the end of the year raw materials, production capacity, cold chain which is a mass production barrier?

    Domestic new crown vaccine is expected to be listed by the end of the year raw materials, production capacity, cold chain which is a mass production barrier?

    • Last Update: 2020-09-29
    • Source: Internet
    • Author: User
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    Recently, China Pharmaceutical Group Co., Ltd. (hereinafter referred to as "National Pharmaceutical Group") Party Secretary and Chairman Liu Jingxuan said that the domestic new coronavirus inactivated vaccine is expected to be available by the end of December this year, two injections less than 1000 yuan.
    domestic new crown vaccine is expected to be listed at the end of the year news, for the market to bring a strong needle, August 18, the national medicine consistent, the national drug shares both rose, the national medicine shares ushered in a rise and stop.
    after all, globally, the power of the new crown outbreak is not diminished, the global new crown pneumonia confirmed cases of more than 23 million cases, the death toll of more than 770,000, the global epidemic is still in the spread stage.
    many parts of the country have also seen repeated outbreaks.
    treatment of the new coronavirus has not yet found a special drug, and the vaccine has become the killer of people to snipe the new coronary pneumonia.
    a new coronavirus vaccine is already available in Russia, safety has not yet been proven because the vaccine has not completed Phase III clinical trials.
    In addition to Russia's new crown vaccine, there are several new crown vaccines in the world into clinical phase III, although the delivery of effective new crown vaccine is currently not exactly scheduled, but if all goes well, the new crown vaccine can be launched as soon as the end of 2020, the key question is whether vaccine capacity can keep up with demand.
    even if the vaccine is approved by the end of 2020, it does not mean that most people will be able to get the new crown vaccine in time.
    in addition to research and development, the new crown vaccine from the approval of the market to mass vaccination, but also through mass production, cold chain transport, scheduled vaccination and other links.
    it is clear that the global demand for new crown vaccines is at least 1 billion doses and that a wide range of coverage will be completed in a short period of time, which seems impossible for any link.
    compared with the listing of HPV vaccine in China, HPV vaccine has been in short supply since its launch in 2018.
    2019, China's HPV four-price and nine-price vaccine issued a total of 8.17 million units, the actual sales may exceed 8 million units, but so far the HPV vaccine is still out of stock and difficult to book.
    the demand for new crown vaccines is in the 1 billionth order, far exceeding the demand for HPV vaccines.
    the new crown vaccine market, China's vaccine industry from production capacity to cold chain transport can undertake the new crown vaccine after the market shock, arterial network combed the relevant information for interpretation.
    china's vaccine industry chain research and development accelerated, the future needs a variety of vaccine candidates according to public information inquiries, there are currently more than 118 candidates at home and abroad in the research and development process.
    's most high-interested companies include the recombinant new coronavirus vaccine adenovirus vector vaccine from Consino, China, the MRNA vaccine from American company Moderna, the new coronavirus vector vaccine from AstraZeneta in collaboration with Oxford University, the mRNA vaccine from BioNTech, a German biotech company, and the DNA vaccine from Inovio, a US biotech company.
    arterial networks to collate the main pathways and representing companies and research and development progress in the current development of new coronary vaccines.
    addition to the "satellite-V" that has been approved for sale in Russia, it can be found that the faster-progressing inactivated vaccine and the adenovirus vector vaccine have entered phase III clinical.
    of course, vaccines that cross the end of clinical trials in the first place may not be the best vaccine, and WHO has said that there are many different types of vaccine candidates needed globally to maximize the chances of finding a successful solution.
    Supply and demand are so uneven that global companies are actively expanding capacity WHO Director-General Tan Desser says the process of developing the new crown vaccine is complex, risky and costly, and when new vaccines are successfully developed, demand will be far greater than supply.
    how many new coronavirus vaccines are needed globally, experts at Johns Hopkins University estimate that, in general, 70-90% of the population is immunized against the virus, which is the basic condition for group immunity.
    That is, according to the world's 7.5 billion people, the new crown of mass immunization needs 5.25-675 million people to be immunized;
    production of 10 billion doses of vaccines is astronomical for global vaccine production capacity.
    , the global vaccine market is an oligopoly, with GlaxoSmithKline (GSK), Sanofi, Mercedon and Pfizer accounting for more than 90% of the vaccine market.
    , GSK's vaccine business is the world's largest, supplying about 1 billion doses of vaccines per year.
    , it can be seen that the demand for 10 billion doses will put great pressure on the global vaccine industry.
    in response to a future crisis in the production capacity of new crown vaccines, vaccine developers around the world are working large-scale production of new crown vaccines.
    GSK has previously said it plans to produce 1 billion doses of adrenatics that can be used in any brand of vaccine to support next year's new crown vaccination.
    in the use of new crown vaccines, the use of vaccine adsages in some vaccines can enhance the immune response, resulting in stronger and longer-lasting immunity than the use of vaccines alone.
    announced that it was building a production facility capable of producing up to 2 billion doses of adenovirus vector vaccine.
    addition, AstraZeneca is working with manufacturers around the world to spread capacity pressures, localize production of New Crown Healthcare, and establish parallel supply chains to support a broad and equitable global supply of vaccines.
    In China, AstraZeneca and Kantai Bio have reached a licensing agreement, one of China's largest vaccine manufacturers, and Kantai Bio, as a technology transferor, will ensure that it will reach production capacity of at least 100 million doses of the new AZD12222 crown vaccine by 2020 and expand the annual production capacity of the vaccine design to 200 million doses by the end of 2021.
    Johnson and Johnson also announced that it is building a production plant with a production capacity of 1 billion adenovirus vector vaccines.
    Johnson and Johnson revealed that its vaccine API plans to be made using the same bioreactive devices as the Ebola virus vaccine, but that the new crown vaccine requires about 90 times the size of the Ebola vaccine.
    Moderna chose to work with Lonza, the world's largest biopharmaceiser, to produce vaccines at two future plants in the United States and Switzerland, with the goal of producing 1 billion doses a year.
    and BioNTech initially worked together in the U.S. and Europe to develop a new coronavirus vaccine and expand production capacity to support global supply.
    the two companies plan to supply millions of doses of the vaccine by 2020 and rapidly expand to capacity of hundreds of millions of doses by 2021.
    demand for new crown vaccines far exceeds China's production capacity, capacity is double expansion specifically in China, in a short period of time the maximum possible production of how many doses of new crown vaccine? In China, according to the data disclosed in Watson Bio's 2019 annual report, there are currently more than 40 vaccine manufacturers in China, can produce 65 kinds of vaccines, prevent 35 infectious diseases, annual production capacity of more than 1 billion doses, is one of the few countries in the world that can rely on their own capacity to solve all immunization program vaccines.
    current annual production capacity of nearly 1 billion doses is based on a variety of vaccines, the new crown vaccine capacity, this data is even more limited.
    the number of vaccines issued, in the first half of 2020, China's vaccine issuance volume was 290 million, an increase of 22.2% year-on-year.
    , China's vaccine market as a whole has fluctuated, with about 565 million issues issued in 2019, essentially the same as in 2018.
    it goes without saying that the demand for new crown vaccines far exceeds our vaccine production capacity.
    will also face many obstacles to the expansion of production capacity in the short term.
    Generally speaking, the production lines of the new crown vaccine are specific production lines with low capacity flexibility, and according to the Vaccine Administration Law of the People's Republic of China, unless approved by the drug regulatory department under the State Council, vaccine enterprises must produce vaccines in-house and cannot outsource production to other manufacturers.
    production of the new crown vaccine needs to be carried out in the P3 (level three biosecurity level) production workshop, however, there was no composite GMP standard P3 level production workshop.
    In order to ensure the accessability of the new crown vaccine after the market, including Hualan Biologicals, China Pharmaceutical Group China Biologicals, Beijing Biological Products Research Institute production workshop, Wuhan Biological Products Research Institute production workshop and other enterprises have started the construction of P3 production workshop, the average production capacity of about 100 million doses.
    production capacity limits, domestic companies are also preparing for mass production of the new crown vaccine.
    , Consino's vaccine industry base had a total floor area of about 38,000 square meters and was designed with an annual raw liquid capacity of about 70 million to 80 million doses, according to data disclosed in the prospecto.
    Chairman Yu Xuefeng said at the HCare Global Health Industry Summit in Gaoxuan that Consino is also stepping up construction of the plant, which is expected to reach an annual production capacity of 200 million doses.
    Pharmaceutical Group has invested about 2 billion yuan to build two P3 (three levels of biosecurity) production workshop.
    expects the annual production of inactivated vaccines by the Beijing Institute of Biological Products (China Biotechnology Co., Ltd., which is part of China Pharmaceutical Group Corporation) to reach 120 million doses, and the annual production of inactivated vaccines by the Wuhan Institute of Biological Products (China Biotechnology Co., Ltd.), which is part of China Pharmaceutical Group Corporation, to reach 100 million doses per year.
    addition, the genetically engineered sub-unit vaccine is expected to enter clinical research in October and, once successfully developed, can be produced quickly and in large quantities.
    Weidong, chairman of The Beijing Science and Technology Coxing Holdings, has said that the Beijing municipal government has opened up a nearly 70,000 square meter industrialization base for The University of Science and Technology in Daxing Medical Park, and the production workshop is being built 24 hours a day.
    , there are many candidates for the new crown vaccine, and different vaccine types put different requirements on the production process.
    also limits the rapid mass production of new crown vaccines.
    the expansion of production capacity and production facilities for conventional inactivated vaccines is not difficult.
    Xinhua Medical's Anglo-German Bio can provide a holistic solution for human vaccine companies, the main process core equipment includes bacterial fermentation systems, cell culture systems, inactivation/detoxification systems, seeding systems, etc.
    Anglo-German Biotech provides key process module equipment for the new high biosecurity grade production workshop of China Bio-Wuhan Products Research Institute of China Pharmaceutical Group, helping to produce the first new crown vaccine.
    But for the mRNA vaccine, Pfizer has said that the mRNA vaccine, developed in conjunction with BioNTech, requires smaller devices and a unique formulation process that requires designing new equipment and retrofitting factories to work with it.
    this undoubtedly makes it more difficult to expand capacity.
    glass bottles can meet demand, but the dependence of vaccine raw materials on imports in addition to production line restrictions, the production of vaccines necessary supporting industries may also be invisible restrictions on the production capacity of the new crown vaccine.
    the raw materials, admissions and medicinal glass bottles needed for the new crown vaccine are likely to become constrained.
    in the case of medicinal glass bottles, experts have been concerned that the new crown vaccine mass production, it is likely to face a global shortage of medicinal glass bottles.
    shortage of medicinal glass bottles has also caused a surge in medicinal glass stocks Shandong Pharmaceutical Glass, Zhengchuan shares and Qibin Group.
    this, the China Vaccine Industry Association responded: China has a high-quality vaccine bottle production industry base, vaccine glass bottle annual output of at least 8 billion or more, to meet the production needs of the new crown vaccine.
    two types of medicinal glass bottles, one is a medium boron silicon glass bottle, the other is a low boron silicon glass bottle.
    the water resistance, thermal stability, anti-freezing and other correlations of boron-silicon glass bottles in the vaccine packaging are better, and vaccine quality can be guaranteed in vaccine packaging.
    Europe and the United States, regulations require the use of mid-boron silicon glass bottles for injection preparations and biologics.
    world's leading manufacturers of mid-boron silicon glass bottles are Schott Group of Germany, NEG of Japan, Corning of the United States.
    in terms of production capacity, Schott Group of Germany, one of the world's largest manufacturers of specialty glass and a supplier of pharmaceutical packaging, announced that the medium boron silicon glass currently available could be packaged in 2 billion doses of vaccine bottles.
    has reached a cooperation agreement with the world's largest pharmaceutical companies with immediate effect, with the first bottles to be delivered to Chinese and overseas pharmaceutical companies.
    the stability of low boron silicon glass is much worse than that of medium boron silicon glass, but there is no mandatory requirement for medicinal glass bottles in China.
    China has not yet had a large-scale production capacity of medium boron silicon glass bottles, China can produce medicinal glass bottles are mainly low boron silicon glass bottles.
    , although the China Drug Administration in 2017 also mentioned that the use of low boron silicon glass and sodium calcium glass is not recommended, but did not make a hard requirement.
    , according to publicly available information, the shortage of medicinal glass bottles worldwide is mainly medium boron silicon glass bottles.
    china can reach an annual output of 8 billion medicinal glass bottles should be mainly low boron silicon glass.
    addition to medicinal glass bottles, the ad accessories and accessories needed for new crown medicine are also critical in future mass production.
    most common admonicides for human vaccines are aluminum hydroxide admonos, as well as MF59.
    in the event of a pandemic, the use of adrenasts is particularly important by reducing the amount of antigens required for each dose of vaccine, thereby producing more doses of the vaccine and making it available to more people.
    mentioned earlier that GSK currently plans to produce 1 billion doses of advents.
    , however, mRNA vaccines do not require other adages, and mRNA itself is a good adage.
    materials needed for vaccine production include fillers, cultures, trypsin and so on.
    can be divided into animal trypsin extracted from the pancreas of pigs or cattle and recombinant trypsin produced by genetic engineering techniques.
    recombinant trypsin according to the gene difference, but also divided into recombinant pig trypsin, recombinant human trypsin and so on.
    the new crown vaccine, coupled with the original immunization program vaccine production, the demand for vaccine raw materials will be very large.
    also reported that the current clinical production of new crown vaccine raw materials and related purification equipment are mainly dependent on imports, therefore, driven by the new crown outbreak, the vaccine upstream raw materials and equipment production.
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