Thursday, September 28, 2023
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.
The launch of the new base in Shanghai will enhance OBiO's production and service capabilities in both China and the United States, spanning from proof of concept and IND declaration to new drug application and commercial manufacturing. In a continuous journey of self-breakthrough and innovation, OBiO has successfully managed over 170 gene and cell therapy CDMO projects, contributing substantively to the approval of 25 global IND applications across diverse regions, including 8 approvals from the US FDA. OBiO has been privileged to collaborate with over 110 esteemed global clients. Meanwhile，this purpose-built facility, spanning 828,000+ square feet and equipped with 29 production lines, has officially commenced operations. This running will sustain and offer comprehensive, all-encompassing services to clients worldwide, effectively addressing the surging demand for gene therapy CDMO solutions and expediting the pace of worldwide pharmaceutical innovation.
Intelli-M site is equipped with a range of single-use bioreactors from 50 to 2000 liters and closed downstream processing, providing flexible scales to tailor customer's needs. By leveraging cutting-edge and proprietary technologies, this facility expands OBIO's process development and GMP manufacturing capabilities.
Equipped with intelligent robotic feeding system, automated filling system, fully automated liquid nitrogen storage system, cleanroom automation chip management, remotely accessible electronic signature systems, and full-lifecycle project visibility, OBiO is on its track to enhance operational efficiency and reduce delivery timelines, becoming a leading global CDMO to expedite clients' CGT to patients.
OBiO Technology, a trailblazer in the field of cell and gene therapy, has dedicated years of expertise and commitment to specializing in and profoundly cultivating these domains. With cutting-edge production techniques, rigorous quality control measurements, advanced manufacturing capabilities, and the ability to scale up for large-scale industrial production, the company has solidified its position as a vanguard in the industry with a strong competitive edge.
