NANJING, China, Sept. 27, 2021 /PRNewswire/ -- EyeGene's mRNA vaccine against COVID-19, namely "EG-COVID", has recently been approved for clinical trials by South Korea's Ministry of Food and Drug Safety (MFDS). GenScript ProBio hereby extended its warm congratulations to the partner.
EG-COVID will undergo a Phase I/IIa clinical trial to test the safety, tolerability and immunogenicity of the vaccine. GenScript ProBio, as a partner of EyeGene, will provide the project with plasmids for mRNA vaccine production. The vaccine uses a cationic liposome-based vaccine delivery system and is produced in a freeze-drying formula. It is refrigerated at 2-8 ℃ for preservation, and is thus competitive for export to foreign markets with insufficient low-temperature refrigeration facilities.
An EyeGene official said: "Now that the pandemic is still raging around the world, we are very excited to get EG-COVID approved for clinical trial. Our scientists have used a cationic liposome-based delivery system for the vaccine, and we are very confident in its safety and effectiveness. GenScript ProBio is the largest plasmid CDMO supplier in China and the China's sole GMP production platform that provides in vitro transcription (IVT) template linearized plasmids for mRNA vaccines. I believe this highly specialized platform can help us accelerate the product launch and defeat the pandemic sooner."
"We congratulate EG-COVID for the clinical trial approval from MFDS," said Dr. Brian Min, CEO of GenScript ProBio. "As the pandemic continued to roam the planet, we have built cooperation with almost all mRNA vaccine companies in China. And we have supported two clients of mRNA vaccine programs get IND approved from the MFDS (South Korea) and PMDA (Japan) We will continue to provide support for the fight against the global pandemic, give continuous attention to the progress of the clinical trials of the EG-COVID project, and hope we can defeat COVID-19 in the near future."
EyeGene took its first step in the development of innovative biopharmaceutical drugs when it was first established in June 2000. Since then, EyeGene's R&D Scientists have continued to research and develop innovative drugs for the treatment and prevention of age-related diseases.
More Info: http://eyegene.co.kr/kor/
About GenScript ProBio
GenScript ProBio is the biologics CDMO segment of GenScript, proactively providing end-to-end service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in antibody drug and gene and cell therapy to accelerate drug development for customers.
GenScript ProBio's innovative solutions for antibody drug development include antibody drug discovery, antibody engineering and antibody characterization. In terms of biologics development service, GenScript ProBio has built a regulatory-compliant platform, from stable cell line development, host cell license, process development, analytical development to clinical manufacturing services, providing fed-batch and perfusion process to accelerate IND process and high quality material for clinical trials. GenScript ProBio has successfully delivered multiple CMC and GMP manufacturing projects.
GenScript ProBio's total gene and cell therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. Our quality management systems ensure phase appropriate compliance, data integrity and traceability.