SHANGHAI, Oct. 24, 2023 /PRNewswire/ -- OBiO Technology (Shanghai) Corp., Ltd. (OBiO, 688238.SH), a world leading contract development and manufacturing organization for cell and gene therapy, officially announced an agreement with Refreshgene Therapeutics (Refreshgene). Under the agreement, OBiO leverages its capabilities of process development, large-scale cGMP commercial production and global business development to provide high-quality CDMO/CMO services and authorized cooperation services for Refreshgene's RRG-001 pipeline, and jointly promote the development of advanced therapies to benefit patients around the world.
SHANGHAI, Sept. 27, 2023 /PRNewswire/ -- In Shanghai, China, on August, OBiO Technology, a prominent leader in the Cell and Gene Therapy (CGT) field and a Contract Development and Manufacturing Organization, proudly unveiled the official launch of its state-of-the-art GMP production facility, christened as OBiO Intelli-M.
FDA Acceptance of Drug Master File Marks New Milestone Achieved for OBiO TECH of GMP Plasmid Products
OBiO Technology Corp., a gene and cell therapy CDMO in China, and Univercells Technologies, a provider of biomanufacturing technologies for flexible and scalable advanced therapies and vaccine production, entered into a strategic agreement to deploy novel technologies in Shanghai.
SHANGHAI, April 29, 2023 /PRNewswire/ -- On April 21, 2023, OBiO Technology (Shanghai) Corp., Ltd. (OBiO) announced a strategic agreement of commercial manufacturing collaboration with CHINAGENE. Under the agreement, OBiO will provide holistic contract development and manufacturing services to CHINAGENE for their gene therapy products, including large-scale cGMP manufacturing service for clinical trials, process characterization and validation services, product formulation and filling services, and commercial manufacturing. In addition, OBiO and CHINAGENE will continue to expand the cooperation in academic communication globally, to promote the innovation of gene therapy.
A new super factory with 29 GMP grade production lines for gene and cell therapy was launched in Shanghai by OBiO technology
SHANGHAI, Jan. 16, 2023 /PRNewswire/ -- OBiO Technology (Shanghai) Corp., Ltd. ('OBiO', 688238.SH), a gene and cell therapy-focused contract research organization (CRO) and contract development and manufacturing organization (CDMO), recently announced that the United States Food and Drug Administration (FDA) has accepted its GMP plasmid DNA drug master file (DMF), DMF Number 037766. 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 helps shorten the communication, review and evaluation time to accelerate the filing of related products.