SK bioscience eagerly awaits final approvals for Covid vaccine

Industry

Published: 11 Aug. 2022, 16:53 Updated: 11 Aug. 2022, 19:29

SK bioscience eagerly awaits final approvals for Covid vaccine

An SK bioscience researcher checks SKYCovione Covid-19 vaccine vials at L House, the company’s vaccine manufacturing facility in Andong, North Gyeongsang. [SK BIOSCIENCE]

ANDONG, North Gyeongsang — SK bioscience researchers were hurriedly conducting the final examination on the SKYCovione Covid-19 vaccine Wednesday afternoon at L House, the company’s manufacturing facility in Andong, North Gyeongsang, with the hope that it could be released as soon as the end of the month.

The examination is the final review before the company submits the lot release application to the Ministry of Food and Drug Safety. The company already won use approval in late June.

"The factory operates 24 hours a day, and SK bioscience employees work night and day on the country's first domestically developed Covid-19 vaccine," said Lee Ju-seop, head of the Quality Control team at L House, during a press tour on Wednesday. "We will apply for the national lot release approval next week, and the vaccine will likely be introduced to the public as early as the end of August."

The 63,000-square-meter (678,126-square-foot) plant is the one and only facility making a Covid-19 vaccine from scratch in the country. The development of a vaccine is largely divided into two parts: Drug substance (DS) development, where the vaccine maker creates the substances with the ingredients, and drug product (DP) development, which simply means the packaging of the products.

SKYCovione vials are lined-up at L House. [SK BIOSCIENCE]

The nine separate labs in the building, which the company calls suites, were full of researchers working on the development of drug substances. Of them, two suites, No. 1 and 4, are being used for SKYCovione.

“The two different suites each have a 2,000-liter cell culture bioreactor and 1,000-liter fermenter,” said Lee Sang-gyun, general manager at L House. “Then we combine the two types of components to make the drug substance for SKYCovione.”

The Wednesday press tour continued to a packaging room where the substances are placed in vials, and 10 vials are placed in a box. One vial can be administrated to 10 people.

It takes around 4 months to produce a SKYCovione vaccine from beginning to end, SK bioscience said.

A researcher holds a box of SKYCovione vials. A box holds 10 vials, which could be administrated to 100 people. [SK BIOSCIENCE]

The expiration date for the product is about six months, though the vaccine maker said the expiry date could increase to much longer in the future after the company collects data when the vaccine is administered to patients.

After being packaged, the vaccine vials are sent to a quality control team to start another examination process. The employees unpack the packages and review the products.

“We have around 10 points to check for the final review,” said Lee.

SK bioscience is expected to make an application for lot release of the vaccine to the Food and Drug Safety Ministry next week. The government officials will visit L House’s quality control team and randomly choose a few products to conduct their own reviews on. If SK earns lot release approval, it can then release the vaccine to the market.

The review by the ministry takes around two weeks. The company predicts it will obtain approval by the end of August.

An SK bioscience researcher checks the quality of SKYCovione Covid-19 vaccine at L House. [SK BIOSCIENCE]

The Korea Disease Control and Prevention Agency already signed a 200-billion-won ($153 million) deal with SK bioscience for 10 million doses of SKYCovione to be administered domestically.

SK bioscience applied for conditional use approval for the vaccine to the European Medicines Agency and Britain's Medicines and Healthcare products Regulatory Agency. It is currently preparing an application for emergency use authorization to the World Health Organization.

Co-developed with the University of Washington’s Institute for Protein Design and funded by the Bill and Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations, SKYCovione is a recombinant vaccine that uses protein antigens. Inside the body, the antigens stimulate an immune response that creates antibodies to fight off the virus.

The vaccines will be especially helpful for people in developing countries, SK bioscience added, as they can be stored in normal refrigerators at 2 to 8 degrees Celsius unlike Moderna and Pfizer vaccines, which use mRNA (messenger ribonucleic acid) technology and require extremely low temperatures to remain effective.

SK bioscience is trying to diversify the use of the vaccine as it is currently undergoing Phase 3 clinical trials for it as a booster shot. The trial data is expected to come out in the first half of next year.

The Korean vaccine maker said it will invest roughly 200 billion won through 2024 to expand the vaccine facility. It plans to buy a 99,130-square-meter site near the L House for that.