Shanghai
,
January 16, 2023
/PRNewswire/ — OBiO Technology (
Shanghai
) Corp., Ltd. (“OBiO”, 688238.SH) is a contract research organization (CRO) and contract development and manufacturing organization (CDMO) focused on gene and cell therapy, recently acquired by the U.S. Food and Drug Administration ( FDA) has approved its GMP Plasmid DNA Drug Master File (DMF), DMF number 037766. DMF approval allows direct reference for Investigational New Drug (IND) applications for lentiviral vectors, autologous cell therapy, allogeneic cell therapy, and stem cell therapy products. , helps accelerate related product submissions by reducing communication, review, and evaluation time.
A DMF is a proprietary submission to FDA that contains confidential information about a facility, process, or article used to manufacture, handle, pack, and store. DMF policies facilitate optimized solutions for pharmaceutical companies, pharmaceutical companies and regulators. Pharmaceutical manufacturers are permitted to submit DMF information to the FDA without disclosing technical secrets. In addition, drug developers are empowered to reference all or part of the contents of the DMF to support IND submissions, saving submission process time and communication costs.
In 2022, OBiO helped clients obtain 12 IND clearances. This includes his three FDA IND approvals and a total of 13 IND application approvals. With many years of successful experience in supporting INDs,
China
When
usa
For a range of gene and cell therapy products, OBiO leverages its valuable know-how in IND-enabling Chemistry, Manufacturing and Control (CMC) services to provide customers with faster and more reliable time to manufacturing and regulatory submissions. and thereby advance gene and cell therapy. Delivering oncolytic virus therapy products from the bench to the clinic to benefit a broader patient population.
“The approval of our DMF application for GMP plasmids relies on OBiO’s experienced technical team and established quality system, which further enables us to provide our clients with comprehensive CDMO solutions from DNA to IND.” will be
Seiryu-kun
, Deputy General Manager of OBiO. “OBiO has supported clients in adeno-associated virus, CAR-T therapy, stem cell and oncolytic virus IND submissions by providing high quality and comprehensive CMC services from bank construction to GMP production. We have FDA approval for our other products and will continue to invest in our pipeline of innovations, from manufacturing technology to process development and quality control.”
In 2020, OBiO built the OBiO Intelli-M site.
77,000m
2
GMP production base with global service capability in Lingang Special Zone
China
(
Shanghai
) a pilot free trade zone that will be piloted in the first quarter of 2023. 50-2,000L, 11 cell therapy production lines, 3 cell therapy production lines for pathogen carriers.
About OBiO Technology
OBiO technology (
Shanghai
) Corp., Ltd. (OBiO, 688238.SH) is a CRO and CDMO dedicated to gene and cell therapy founded in 2013.
China
We provide comprehensive research, development and manufacturing solutions for vectorology research, functional genomics, process and analytical development, IND-ready CMC, clinical and commercial manufacturing for our global clients. With the mission of “Enabling Gene Therapy for a Better Life”, we are committed to providing high-quality service to our global customers, advancing our products from the bench to the clinic, and benefiting people around the world. It is working. For more information,
For more information on OBiO Technology, please visit www.obio-tech.com.
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Source OBiO Technology (
Shanghai
)Ltd
