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FDA Acceptance of Drug Master File Marks New Milestone Achieved for OBiO TECH of GMP Plasmid Products
29th Jun. ,2023

    OBiO Technology (Shanghai) Corp., Ltd ('OBiO', 688238. SH) is a biotechnology company focusing on the cell and gene therapy field. Recently announced that the U.S. Food and Drug Administration (FDA) has successfully obtained the GMP plasmid DNA Drug Master File (DMF) filing, DMF Number 038404 and 038405, together with the previously filed DMF 037766, covering three helper plasmid products required for lentivirus production.


    OBiO has completed the DMF filing for the three helper plasmids used in lentivirus production. The DMF acceptance enables a direct reference for investigational new drug (IND) filing for lentiviral vectors, autologous cell therapy,  allogeneic cell therapy, and stem cell therapy products, and drug developers could be authorized to reference all or part of the content of a DMF in support of its IND application, This successful filing will further drive OBiO to provide convenience to more biopharmaceutical companies, saving time and communication costs for the application filing process and accelerate the process of drug project submission and approval.



    OBiO offers comprehensive CDMO solutions for lentiviral vector, suppling suspension and adherent platforms for lentiviral vector production. The performance of the suspension platform is comparable with the adherent one. The platforms consist of serum-free cultured suspension HEK293 cell line with clear source, and in-house patented packaging plasmid system that is adaptable for different transgenes. Our lentiviral vector production is easy to scale up, and ensures high titer, high infectious efficiency and low residual. With a wealth of experience, OBiO supports our clients from IND to commercial manufacturing. Notably, OBiO already have assisted BIOHENG in obtaining IND approval for their UCAR-T product, which is the first "off-the-shelf" CAR-T product entering clinical trials in China.


About OBiO Technology

    OBiO Technology (Shanghai) Corp., Ltd. (OBiO, 688238.SH) is a gene and cell therapy-focused CRO and CDMO founded in 2013. In China for global customers, we offer holistic research, development, and manufacturing solutions for vectorology studies, functional genomics, process and analytical development, IND-enabling CMC, clinical and commercial manufacturing. With "enable gene therapy for better lives" as our mission, we are committed to providing high-quality service to global customers, advancing your product from bench to clinic, and bringing benefit to populations around the world. For more information about OBiO Technology, visit www.obio-tech.com.

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