SHANGHAI, China – OBiO Technology (Shanghai) Corp., Ltd. (“OBiO” or “the Company”), a leading gene and cell therapy CDMO in China, announced the launching of a new GMP manufacturing base, named OBiO Intelli-M, April 21, 2023.
The new base was located in the China (Shanghai) Pilot Free Trade Zone, Lin-Gang Special Area, with 29 production lines and 828,000+ square feet in area, which was one of the biggest super factories for gene therapy in the world.
At the opening ceremony, OBiO showed the holistic process development capability and large-scale GMP manufacturing capacity in variety gene and cell therapies. According to OBiO’s introduction, OBiO Intelli-M contains 11 different vector production lines from Cytiva, Sartorius, ThermoFisher, Austar, for different kind of gene vector manufacturing.
These lines include manufacturing processes with cell factory, roller bottle, fixed-bed, and 50 L/200 L/250 L/500 L/1000 L/2000 L single-use bioreactor. Meanwhile, OBiO Intelli-M have 18 cell production lines for autologous and allogeneic immune cell therapies and stem cell therapies, in which 3 complete independence lines are used for cell therapies in infectious disease patient. OBiO Intelli-M will continue to provide the holistic contract research services and contract development and manufacturing services (i.e. CRO/CDMO) to global clients in gene and cell therapies, with one-stop solution from proof of concept, IND declaration, new drug application, to commercial manufacturing, to accelerate gene and cell therapy.
Founded in 2013 and headquartered in Shanghai, OBiO is a biotechnology company focusing on gene and cell therapy field: serving as a contract research organization for vectorology and functional genomics studies and providing contract development and manufacturing services of IND-enabling CMC, clinical and commercial manufacturing. In recent years, in line with the mission of ‘enabling gene therapy for better lives’, OBiO has established core technologies around vectorology development, large-scale process development and manufacturing, facilitating a robust and versatile GMP manufacturing system for various gene and cell therapy products. With the policy supports on gene therapy and CRO/CDMO industry, OBiO has achieved a sustainable growth in market size.
“Under the situation of the rapid development of gene and cell therapy, large-scale GMP viral vector manufacturing the foundation and key for the clinical applications of gene and cell therapy, as well as the bottleneck of gene therapy industry.” said Oudong Pan, chairman of OBiO. “The completion of OBiO Intelli-M, is a critical milestone for the development of OBiO technology, as well as for the gene therapy.”
Driven by technical innovations, policy encouragements, and capital promotions, gene and cell therapy has gradually entered a “golden age” of commercialization. As of the end of 2022, more than 20 gene therapy drugs have been approved and entered clinical applications globally. According to the Landscape Report 2022Q4 from ASGCT, 284 gene therapy pipelines were entered into phase II clinical trials or later. At the same time, according to J.P. Morgan, due to the typical high technological barriers and strict regulatory policy characteristics of gene therapy development, the rate of gene and cell therapy outsourcing has exceeded 65 percent.
With the sustained rapid growth of the global CGT market in the future, CDMO (contract development and manufacturing organization) companies will also rise to the occasion and are expected to fully share the industry’s high-speed growth dividends.
“Innovative is always the ‘engine’ for drug discovery and human health. Thus, investments in biomedicine is the eternal hot spots.” said Peimin Zong, founder and chairman of SINOWISDOM investment, one the earliest investors to OBiO, “With the mission of ‘enable gene therapy for better lives’, OBiO will continue to serve clients from all over the world, and will expand their service abilities with the supporting of this new base.”
In future, with the new base, the manufacturing capacity of OBiO technology will be greatly increased to meet the increased demands.
At the opening ceremony, OBiO reached strategic cooperations in commercial manufacturing services with ImmVira, a leading biotech focused on development of new generation novel anti-cancer drugs, and CHINAGENE THCH, a leading AAV-based therapeutics developer. Moreover, OBiO and HOPE FOR RARE FOUNDATION reached the agreement on comprehensively cooperation to promote the clinical transformation of advanced therapies.
