GenScript Biotech Corp. (HK.1548) subsidiary Legend Biotech surprised ASCO by posting promising data for its anti-BCMA CAR-T cell product in 2017.Leading the industry constantly is what GenScript pursues, it created another dark horse named GenScript ProBio. Building upon GenScript’s solid gene synthesis technology and deep expertise in the antibody, cell, and gene therapy fields, GenScript ProBio was created to accelerate biopharmaceutical innovation.

International standards and a global vision

The pain points of R&D demand and application have jointly led to the prosperity of the cell and gene therapy CRO and CDMO industries. CDMO companies ­­­­­can reduce costs through automated production and standardized manufacturing of lentiviruses and plasmids. Based on this trend, domestic and foreign CDMO companies have risen rapidly. As a global CDMO company, GenScirpt ProBio has come a long way in a short 4 year history and quickly became the top CDMO companies in CGT field in China.

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.

“Innovation in Chinese biopharma is fast becoming a notable story. I joined the company to help more innovative Chinese companies move forward on the world stage, and I hope to bring promising treatments worldwide to benefit patients in need,” Brian Min, PhD, CEO of GenScript ProBio.

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.

With the leadership and global vison of Dr. Brian Min, GenScript ProBiohas made impressive achievements in just a few years. As of November2022, the company helped its global clients receive 19 IND approvals in biologic drugs and 22 INDs in cell and gene therapy, which includes customers in the U.S., Europe, Korea, Japan, and China, and others. 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.

Customer first, quality first

Dr.BrianMinsaid,“The development of cell and gene therapy drugs is difficult, the control of process is complicated, and there is a shortage of compound talents with good technology, process background and rich production management experience in the industry, and relatively mature CDMO companies often have explored and solved these problems in the early stage of establishment. For startups, the time cost is the biggest cost they face. ”

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. It has helped global customers obtain more than 40 IND approvals since October 2017.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).

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 in China to provid the services of circular plasmids, linearized plasmids, mRNA in vitro transcription (IVT-mRNA) and liposome nanoencapsulation (mRNA-LNP)and sterile filling for nucleic acid drugs. 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.