Samsung Biologics has begun production of Moderna COVID-19 vaccine and secured supplies before GMP approval.
It is reported that Samsung Biologics has completed the test-production of Moderna's COVID-19 vaccine and started manufacturing commercial vaccines.
According to the pharmaceutical and bio industries on the 4th, Samsung Biologics is preparing the production of Moderna vaccine in the third quarter of this year as scheduled before.
Also, Samsung Biologics has reportedly secured enough vaccines to supply in Korea and overseas by starting the commercial production after test-production of Moderna COVID-19 vaccine in August.
Previously, Samsung Biologics signed a CMO (Contract Manufacturing Organisation) contract with Moderna to produce finished mRNA COVID-19 vaccines including filling vials and labeling. It agreed to supply finished vaccines to the U.S.
However, the Ministry of Food and Drug Safety's GMP (Good Manufacturing Practice) evaluation of Samsung Biologics' Moderna vaccine manufacturing facilities has not yet been completed.
This is a procedure for the Ministry of Food and Drug Safety to check whether pharmaceutical manufacturers produce drugs in accordance with standards and control the quality.
Moderna's vaccine has been approved for import by the Ministry of Food and Drug Safety in May, but the vaccine produced by Samsung Biologics requires GMP certificate and product approval from the Ministry of Food and Drug Safety due to the difference in manufacturing facilities.
Moderna's COVID-19 vaccines, which are currently inoculated in Korea, were produced by foreign manufacturers.
Moderna vaccine produced by Samsung Biologics has not been applied for the approval from the Ministry of Food and Drug Safety and has not been shipped anywhere yet. However, as the Minister of Food and Drug Safety Kim Kang-lip said, "We are expecting that the GMP will be approved for Samsung Biologics facilities within this month," it is analyzed that the related processes have been being carried out fast. (ANI/Global Economic)
( With inputs from ANI )
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