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On November 6, GenScript ProBio, the CDMO segment of the world's leading biotech company GenScript, held the opening ceremony for GenScript ProBio Bio-MFG GMP Clinical Manufacturing Center & Innovative Collaboration Models to Accelerate Antibody Drug Development and Investment Forum in Nanjing, Jiangsu Province. The Chinese brand name of GenScript ProBio, “金斯瑞蓬勃生物”, was officially released. Earlier, GenScript upgraded the original CDMO platform to a brand named "GenScript ProBio", expanding GenScript's advantages in the CDMO field.
GenScript ProBio is the largest one-stop discovery and development service platform that covers antibody drugs and cell and gene therapy (CGT) in Jiangsu Province. The platform consists of Nanjing Biologics Manufacturing & Development Center and GenScript Zhenjiang Commercial Manufacturing Center, covering a total area of about 210,000 m2. After commissioning, the platform is expected to deliver a cumulative capacity of 47,600 liters of antibody drugs. The facilities are designed and built in compliance with GMP requirements of the US, EU and China.
The center will be connected with GenScript's existing life science reagent service platforms for gene, peptide, protein and antibody across upstream and downstream areas. After it is fully put into operation, pre-clinical research, clinical trials, and commercialization stages will interplay with the whole supply chain system from R&D, procurement to production. The center will meet customer needs from target to clinical trial filing, from basic R&D to discovery and development to drug industrialization, provide customers with more efficient and flexible R&D and production services, and accelerate the commercialization of new drug R&D.
GenScript ProBio is operating two business lines: antibody drugs and CGT. For antibody drug services, GenScript ProBio has been expanding its antibody discovery capability and building its process development capability since 2004. With 16 years of experience, GenScript ProBio has helped a number of customers with IND filing. Prior to this capacity expansion, GenScript ProBio is already able to provide integrated antibody drug CDMO services from target to IND, and owns an antibody drug R&D laboratory and a GMP-compliant pilot-scale production facility with a capacity of 450 liters.
This antibody GMP manufacturing center will provide GMP manufacturing services for Phases I and II clinical trials. Its industry-leading facilities and capacity can support the manufacturing of several samples at the same time. Our technical team has established a comprehensive and refined technical process and model and conducted comprehensive risk control, ensuring the transfer of customers' projects and manufacturing. The launch of the antibody GMP manufacturing center will underpin the capacity and technological advantages of GenScript ProBio.
In addition to its expertise in antibody drug services, with its insight into the biologics industry, GenScript ProBio has established its presence and expanded its capacity in line with customer needs. Also, GenScript ProBio has developed one-stop CGT services and built a one-stop service platform for discovery and development. In March 2018, GenScript ProBio helped Legend Biotech obtain China's first approval for CAR-T therapy clinical trials. In September 2020, GenScript ProBio helped Xiangxue Life Sciences obtain US FDA clinical trial approval for China's first TCR-T program targeting solid tumors.
Since the outbreak of COVID-19, GenScript has played an active part in fighting against the epidemic with its R&D and industrial advantages. From virus detection services to anti-epidemic drug and vaccine development to donation of medical supplies to medical institutions, GenScript went all out in the "battle" against the epidemic. As a CDMO platform with the largest number of plasmids used for coronavirus mRNA vaccines, GenScript ProBio leverages its technical expertise in plasmid production to facilitate mRNA vaccine developers.
At the forum, leading regulatory experts and investors in the industry shared their professional insights. The speeches covered hot topics such as how innovative business models promote medicinal development, investment opportunities with innovative drugs in the context of COVID-19 epidemic, challenges and solutions to IND filing for biologics under new regulations, technical elements and strategies for technology transfer of biologics, etc.
Dr. Brian Min, CEO of GenScript ProBio, delivered a keynote speech titled How Innovative Business Models Promote Drug Development. He noted that both large pharmaceutical enterprises and small and medium-sized innovative pharmaceutical enterprises are exploring optimal R&D and manufacturing solutions on the decline of ROI and success rate of innovative drug R&D. Different CDMO business models have emerged in response to needs. By integrating resources from innovative pharmaceutical enterprises, investors and CDMOs, we can expedite pharmaceutical transformation and create a healthy future together. Meanwhile, GenScript ProBio will keep following COVID-19 epidemic information and facilitate vaccine development.
"Over the past 18 years, built upon its leading gene synthesis technology, GenScript has developed four major platforms, including the contract research organization (CRO) platform, the biologics contract development and manufacturing organization (CDMO) platform, the cell therapy platform,and the industrial synthesis product platform. GenScript has continuously invested in talent pipelines, innovation, R&D, infrastructure and other core competencies that are essential to the longevity of an enterprise, building underlying strength. GenScript will always grow with our customers and drive industrial development and progress," said Patrick Liu, GenScript Rotating CEO.