SK bioscience announced that it has finished a periodic World Health Organization Good Manufacturing Practice (WHO GMP) evaluation solely through a documentary review, bypassing an on-site inspection, at its Andong L HOUSE production site.
The company stated that the three-year GMP assessment included four WHO prequalified vaccines: SKYCellflu and SKYCellflu Quadrivalent for influenza, SKYVaricella for varicella, and SKYTyphoid for typhoid.
WHO GMP inspections usually necessitate on-site visits to production facilities to confirm manufacturing and quality management systems in person.
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The review for the Andong facility was conducted exclusively based on submitted documents, which SK bioscience stated demonstrates WHO's trust in the site's operational procedures and quality management systems. The firm stated that the result is also related to the increasing global recognition of Korea's pharmaceutical regulatory system after the Ministry of Food and Drug Safety was named a WHO-Listed Authority.
According to WHO's Regulatory Reliance policy, the organization is permitted to utilize the inspection outcomes and evaluations from listed regulatory authorities to substitute on-site inspections with document reviews in specific instances. The company stated that the ministry assisted in submitting the documentation requested by WHO.
SK bioscience announced that the Andong L HOUSE facility, which received European Union GMP certification in 2021, has successfully undergone inspections by various international regulators and health authorities. The firm has recently finalized its inaugural international procurement agreement for SKYCellflu, its independently developed influenza vaccine.
The successful conclusion of this WHO documentary GMP assessment shows that the GMP processes and quality management systems at our Andong L HOUSE facility comply with globally acknowledged standards.
Earlier, SK bioscience announced it will spearhead an artificial intelligence (AI) initiative financed by the Gates Foundation to accelerate decision-making in the vaccine development process. The Research Optimization & Trial Outcome Recommender (ROTOR) initiative will create an AI system that evaluates clinical and scientific data produced during vaccine development to assist researchers in determining the best way to progress a candidate vaccine.
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The company stated that the global health nonprofit PATH and the consulting firm Slalom will also participate. In drug development, firms generally determine whether to proceed to expensive Phase 3 trials depending on the outcomes of Phase 2. That choice is more challenging for numerous vaccines, such as rotavirus vaccines, because researchers frequently do not have a dependable biological marker — a correlate of protection — that indicates if a vaccine will be effective, or because laboratory tests yield inconsistent findings.
SK bioscience stated that the AI platform is designed to make that process more systematic and diminish expensive speculation. The platform will be initially constructed and evaluated using rotavirus vaccine information from SK bioscience and PATH, intending to ultimately assist vaccine creators in low-income nations and broaden worldwide vaccine availability.
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SK bioscience has collaborated before with the World Health Organization, the Coalition for Epidemic Preparedness Innovations, and the U.S. Centers for Disease Control and Prevention (CDC), along with other health organizations. It has recently entered into a licensing agreement with the CDC for an injectable rotavirus vaccine and is independently working on an RSV antibody therapy with the Gates Foundation's research institute.