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GenScript ProBio is the subsidiary of GenScript Biotech Corp. (HK.1548), building upon GenScript’s solid gene synthesis technology and deep expertise in the antibody, cell, and gene therapy fields, GenScript ProBio was created by GenScript Biotech to accelerate biopharmaceutical innovation.
International standards and a global vision
Toward its mission of “Innovation through Collaboration,” GenScript ProBio has a global vision based on a commitment to international biopharmaceutical R&D and biomanufacturing standards. It has established GMP capacity which meets FDA, EMA, and NMPA regulatory requirements. In 2019, Brian Min, PhD, joined as the CEO of GenScript ProBio and to form a management team with an exceptional international perspective.
Previously, Min led the development and manufacture of all biosimilars at Samsung Bioepis. He also had worked at Amgen for over 10 years specializing in antibody discovery. Min arrived at GenScript ProBio after having developed expertise over 30 years in biopharmaceutical discovery, manufacturing, strategic planning, and business development. Each core member of the team has more than 15 years working experience at recognized international firms such as Roche, Pfizer, Henlius, and Innovent, among others.
Customer first, quality first
GenScript ProBio’s motto is “customer first, quality first.” The company has implemented a system for Phase Appropriate Compliance. Depending on the stage of a project, different levels of quality oversight are applied.
For example, clinical Phase III and commercial projects would require more stringent levels of GMP production and oversight than clinical Phase I projects. Currently GenScript ProBio’s Phase Appropriate Compliance system can meet the customer and regulatory requirements of countries such as China, the U.S., and Europe. In addition, GenScript ProBio has established a Customer Quality Verification project management platform to provide customers with the highest quality efficiency. The QA leader has more than 20 years of experience in various regions and has created a culture of quality ranging from managers to employees.
Based on its PAC system and Commissioning, Qualification, and Validation (CQV) project management platform, GenScript ProBio’s record of accomplishment is quickly gaining widespread recognition. As of September 2022, the company helped its global clients receive 17 IND approvals in biologic drugs and 20 INDs in cell and gene therapy, which includes customers in the U.S., Europe, Korea, Japan, and China, and others. In cell and gene therapy, GenScript ProBio supported China’s first CAR-T, TCR-T, mRNA vaccine, and CRISPR programs to be approved for clinical trials by the National Medical Products Administration (NMPA).
Since the outbreak of COVID-19, GenScript ProBio has played an active part in tackling the epidemic with its R&D and industrial rapid response capabilities. The company has not only supported several mRNA vaccine enterprises to obtain clinical approval by China’s NMPA, but also helped mRNA vaccine projects of its customers in South Korea and the U.S. to successfully obtain clinical approval by the KFDA in Korea and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
In the future
GenScript ProBio has extended its operations from China to the global stage. The company has established the largest GMP plasmid facility and the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines in China. It has also set up companies and facilities in the U.S., the Netherlands, South Korea, Shanghai, Hong Kong, and Nanjing in China and other places to serve global customers.
Focused on building a healthy future for humankind, GenScript ProBio will continue to assist in helping global customers shorten the timeline for the development of biological drugs from discovery to commercialization while significantly lowering R&D costs.
Learn more www.genscriptprobio.com.