●SK chemicals, Ready for Commercial Production in its Vaccine Plant at Andong
- Acquired Goods Manufacturing Practices (GMP) Prequalification
- Production can start right after product approval. The products will be supplied to domestic and
foreign markets.
- Response to national crisis and contribution to the localization of the vaccine / protection
of vaccine sovereignty
SK chemicals (CEO: In-suk Lee) has completed all the preparations required for the full operation of its vaccine plant.
SK chemicals announced on the 18th of this month that its vaccine plant (L House) at Andong received GMP prequalification approval from the Ministry of Food and Drug Safety.
As a medical product manufacturing and quality control standard, GMP is a system by which the government certifies the plant that produces safe medical products of excellent quality. With this GMP prequalification approval for L House, SK chemicals has completed all the preparations required for the production of vaccines in this plant.
Starting with the flu vaccine that used a cell culture method and is currently in deliberation for product approval, SK chemicals is planning to produce all the vaccines, which are being developed, in this plant and supply them to the foreign market as well as to the domestic market. In addition, mass production of the new vaccines to prevent a new type of epidemics in the future will be possible in this plant right after their development.
SK chemicals has already concluded the contract for the joint development and export of a next-generation pneumonia vaccine with Sanofi Pasteur. It also made a contract with the International Vaccine Institute for the joint development of a typhoid vaccine for export to developing countries. So L House will be able to establish itself as the international center of vaccine production in the future.
CEO In-suk Lee of SK chemicals expressed his gratitude saying, "After starting the construction in June 2011 to secure vaccine sovereignty in preparation for future crisis and to advance into the global market, we have finally completed the vaccine plant of the world-class level with support from relevant institutions, such as the "global vaccine development support group" and the "WHO-PQ certification support committee" of the Ministry of Food and Drug Safety as well as active cooperation from Gyeongbuk Province and Andong City.
Constructed on the 63,000-m2 site in Gyeongbuk Bio Complex (Andong), L House includes all necessary facilities, such as undiluted solution and end-product production facilities and supplementary facilities, such as product test facilities (QC/QA) and warehouses. In addition, it also has pilot facilities for the production of next-generation products, leading the localization of vaccines and its export.
Active support from the enterprise-tailored "World Health Organization Prequalification (WHO-PQ) certification support committee" of the Ministry of Food and Drug Safety helped SK chemicals establish the basis for WHO-PQ certification, which is an international procurement market bidding qualification. Accordingly, the global market expansion of SK chemicals vaccines is expected to be further accelerated.
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*WHO-PQ (World Health Organization Prequalification) WHO-PQ is WHO`s process of examining and certifying the quality, safety, and effectiveness of the vaccines for its supply to underdeveloped countries. Only the PQ-registered items are qualified to bid for the international vaccine for the UN organization (UNICEF and others).
[Reference] Cell Culture Flu Vaccine
"Cell culture flu vaccine" is made using a new method of vaccine production even without a fertilized egg, which uses animal cell culture fluid. The production facilities that use this method are drawing attention as the facilities that can respond to global crisis because they can produce a relevant vaccine within 3 months by immediately responding to sudden epidemics and they are free from external pollution, such as avian flu.
In the United States, the cell culture vaccine production facilities were constructed with government support to cope with any possible crisis in the future after swine flu. While the raging epidemics caused by unexpected viruses are consecutively breaking out recently, such as Ebola virus in Africa, Chikungunya virus in the United States, MERS in the Middle East, and avian flu in China, the capacity for vaccine production to cope with emergency situations is regarded as more important.
SK chemicals is preparing for possible crisis in the future by constructing "flu vaccine production facilities in the cell culture method" in its L House for the first time in Korea with support from the "Influenza Vaccine Raw Material Tailored-type Production Support Project," a cooperative project of the Ministry of Knowledge Economy in connection with the metropolitan economic region.
[Reference] SK chemicals Vaccine R & D Portfolio
SK chemicals is developing various vaccines to respond to the possible national crisis in the future, to localize the vaccine, and to advance into the global market.
Cell culture flu vaccine
To respond to the possible national crisis in the future, SK chemicals has completed clinical trials and applied for product approval for three kinds of flu vaccine (which are effective in preventing three kinds of viruses) produced in the cell culture method, and they are expected to be released as early as before the end of this year. SK chemicals also started the phase 1 clinical trial for four kinds of flu vaccine that can prevent four kinds of viruses in February of this year.
[Reference] Localization of vaccine and expansion into the global market
Currently, SK chemicals is carrying out phase 3 clinical trial for a pneumonia vaccine that can prevent 13 kinds of pneumonia viruses, and it is also developing a shingles vaccine.
In March this year, SK chemicals also enhanced the status of Korean vaccine technology by concluding the next-generation pneumonia vaccine development and export contract with Sanofi Pasteur, the number 1 global vaccine enterprise.
Furthermore, SK chemicals is developing a typhoid vaccine jointly with the International Vaccine Institute for export to developing countries for the implementation of its corporate mission to promote human health.
[Photo explanation]
The front view of the L House, the vaccine plant of SK chemicals constructed at Andong. SK chemicals prepared various vaccine production facilities, including cell culture vaccine facilities in this plant, to respond to possible crisis in the future.
[Photo explanation]
An SK chemicals researcher is inspecting the quality of a vaccine in production. SK chemicals has completed all the preparations required for the full operation of its plant by acquiring GMP for L House, a vaccine plant constructed at Andong