SK Bioscience (SK Bio) on August 23rd began shipping the world's first cell-cultured influenza (flu) vaccine, SKYCellflu Quadrivalent, in three years after it was suspended from domestic supply following COVID-19.

SK Bio plans to ship a total of 5 million doses, of which 2.42 million doses will be supplied to the National Immunization Program (NIP) and the rest to hospitals and clinics by the end of the year.

SK Bio's Andong L House in Gyeongsangbukdo, visited by Wikileaks Korea on August 22nd, was in the midst of last-minute work on a day before the shipment of SKYCellflu. L House is the largest flu vaccine factory in Korea with an area of 62,000 square meters (about 20,000 pyeong), completed in 2012.

The factory has nine separate suites (production facilities) to produce the vaccine solution, with SKYCellflu being produced in suites 5 and 9.

L House is the SK Bio's vaccine production outpost.

SKYCellflu is a flu vaccine that applies a strain of canine kidney cells (MDCK cells) for its production. The flu virus was injected into dog cells, which are then grown in a 2000-liter sterile incubator to produce the vaccine.

Mr. Jang Hyun-Jin, the leader of the L House Vaccine Solution Team explained to the reporter, "After the cells proliferate, we eliminate the impurities other than the proteins used in the vaccine.

The final product is made by mixing four standard solutions (virus strains) produced this way. We have been working on this process for the past four months and completed the production of 5 million doses of the final product, which is the amount to be supplied in Korea".

On the day, L House completed the production of the vaccine solution and was in the process of packaging and quality control. A total of four types of vaccines were produced by cell culture. They were vaccines against four influenza viruses, including two type A viruses and two type B viruses. 

The final vaccine solution is put into a syringe (syringe) and becomes a finished product.

Coming out of the Vaccine Solution room and entering the Finished Product room, the sound of machines running continuously rang in ears. Employees who were paying special attention to hygiene in lint-free clothes, shoes and caps were busy inspecting the products.

The automated process poured out hundreds of syringes per minute. Lined up in rows, the syringes were loaded and labeled. A robot picked up the syringes in batches of 10 and placed them in boxes, each of which was then stamped with a serial number.

SK Bio's average daily flu vaccine production is 150,000 doses. With 10 doses per box, that is equivalent to 15,000 boxes. The maximum production rate per hour is 18,000 doses.

Products that are determined to be defective, such as inclusion of foreign objects or damage, go through a secondary inspection, and the final defect rate is less than 1% after the secondary inspection.

The next stop was the Quality Control (QC) room, which had a different, more stringent vibe to it.

Instead of busy machines, it was impressive that researchers were engaged directly in experiments. This is where the hemagglutinin content of SKYCellflu antigens, the appropriate amount of antigens and antibodies, virus inactivation, and the presence of exogenous viruses are tested. Sterility tests, endotoxin tests, and mycoplasma negativity tests are all performed here.

Mr. Lee Ju-seop, the leader of the QC Team, said, "We are working around the clock on weekends and holidays to meet the shipping schedule. With our capacity built on previous experience in production of COVID-19 vaccines commissioned from AstraZeneca and Novavax, we are producing reliable vaccines with more qualified personnel than any other organization in Korea.“

SK Bio is looking to expand overseas markets with its first flu vaccine in three years.
It has already obtained approval from ten countries including Malaysia, Thailand, the Philippines, and Singapore, and is in the process of doing so in 10 more countries. 

"SKYCellflu is the culmination of advanced vaccine technology, and we aim to expand domestic flu vaccine options and prove our vaccine competitiveness in the global market," said Mr. Lee Sang-kyun, head of L House, showing full of confidence.

[WIKI KOREA=Cho Eun, Reporter(Andong)]

choeun@wikileaks-kr.org

Cho Eun, Reporter(Andong) 다른기사 보기

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