28 September 2023 | Thursday | News
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.
OBiO Technology CEO Guodong Jia said: "Currently, this industry is in a rapid development phase, characterized by intricate process development and challenging large-scale production requirements. These factors also place higher demands on the service capabilities of CDMO companies. Simultaneously, they impose stricter requirements on our newly established production lines, which must continuously meet regulatory standards and address varying client needs in areas such as cell preparation, viral vector, and plasmid production.
In the future, OBiO Technology will continue to navigate these challenges, enhancing our ability to address scalability issues and overcome hurdles in the CGT field, ultimately expediting the transition from CGT research and development to commercialization."
Intelli-M is up and running in manufacturing Phase III CGT products for our clients. With the addition of this state-of-the-art and GMP-compliant clinical manufacturing facility, and OBiO's specialized expertise in viral vectors (such as AAV and LVV, the most commonly used vectors), oncolytic virus, plasmids and mRNA, OBiO is positioned to enhance its CGT business and integrated end-to-end solutions for our global customers.
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.