2021. 05. 17
Manufacturing facility obtains GMP certification from the EMA for Novavax’ COVID-19 vaccine candidate in April, following certification for AstraZeneca vaccine in March
First domestic vaccine production facility to obtain EU GMP certification validates proof of capacities for global production
Preparations started for cGMP certification from the US FDA, strengthening the CMO/CDMO business
SK bioscience, which has become a global hub for COVID-19 vaccine production, has obtained an international certification recognizing its excellent vaccine production capabilities.
SK bioscience (CEO Ahn Jae-yong) announced on May 17th that the production facilities, processes, and quality systems for both AstraZeneca and Novavax COVID-19 vaccine manufacturing in operation at the Andong Plant L House have obtained EU-good manufacturing practice (GMP) certification approval by the European Medicines Agency (EMA). This is the first time the domestic vaccine production process has acquired EU-GMP
GMP is a certification system that applies strict management standards to all processes for the manufacturing of excellent pharmaceuticals, beginning from the purchase of raw materials to manufacturing, quality control, and shipping. EU-GMP in Europe is one of the world’s leading certification systems, along with current good manufacturing practice (cGMP) in the United States.
SK bioscience obtained final certification for the manufacturing of AstraZeneca’s COVID-19 vaccine on March 29, and for Novavax´ vaccine candidate’s CDMO facilities on the 26th of last month, upon undergoing a screening process, including EMA´s on-site due diligence and document reviews, for approximately one month.
With the EU-GMP certification adding momentum to the entry of SK bioscience’s factory-made COVID-19 vaccines into the European market, SK bioscience is now planning to prepare for cGMP certification, which needs approval by the US Food and Drug Administration (FDA).
Once cGMP certified, plans are also brewing to expand the L House to meet the growing demand by global companies for vaccine Contract Manufacturing Organization (CMOs) and Contract Development and Manufacturing Organization (CDMOs).
SK bioscience’s L House consists of advanced technology-based manufacturing facilities and R&D personnel optimized to carry out vaccine production, including activities such as cell cultivation, bacterial cultivation, gene recombination, and protein conjugation, so that even the newest vaccines can immediately enter mass production.
SK bioscience CEO Ahn Jae-yong said, “With the pandemic, the global vaccine demand is expected to increase explosively, and SK bioscience is at the center of it,” and “Based on our globally recognized technologies, we will accelerate our business expansion.”
SK bioscience has attracted attention by successively signing CMO and CDMO contracts for COVID-19 vaccines that were developed on a global level.
In July of last year, a CMO contract was signed by SK bioscience to manufacture both the drug substance and the final product of the COVID-19 vaccine developed by AstraZeneca and Oxford University in the UK. This followed the Letter of Intent signed between SK bioscience, AstraZeneca and the Ministry of Health and Welfare to accelerate vaccine manufacturing to help stem the pandemic in Korea and abroad.
In August of last year, a CDMO contract was signed to develop and produce Novavax’ COVID-19 vaccine.
In February, SK bioscience signed a license contract with Novavax to secure the rights to produce and sell its COVID-19 vaccine candidate, ´NVX-CoV2373,´ in South Korea.
Currently, global companies have not stopped their requests for the consignment production of COVID-19 vaccines, and SK bioscience is in the process of reviewing additional contracts and extensions, while in consideration of the production schedule of its own vaccine.