Shanghai LIFE Medical Science and Technology
Exploring Innovative Approaches to Cell Gene Therapy

Cell gene therapy (CGT) is one of the most promising frontiers in the fight against complex diseases like cancer and genetic disorders. Lentiviral vectors have become widely used carriers in the creation of novel gene and cell-based treatments. With four U.S. FDA-approved products from Novartis, BMS, and Legend Biotech employing these vectors as delivery tools for therapeutic genes, many researchers are looking to capitalize on their imminent opportunities.

Supporting them with its innovative Lenti-Virus Vector (LVV) Technology Platform is Shanghai LIFE. Designed to enhance process refinement and improve manufacturing capabilities, its solution is poised to unlock a streamlined approach to developing ground-breaking CGT.

Producing lentiviral vectors typically involved a transient transfection process, which was complex, cumbersome, and plagued with various challenges. Recognizing the impact of problems like quality control issues, batch variability, high false positive rates, and elevated production costs, Shanghai LIFE embarked on a journey of innovation to revolutionize the vector production process.

It began with research to develop stable packaging and production cell lines for lentiviral vectors. This entailed the introduction of structural plasmids responsible for viral packaging into the initial cell line, constructing a cell line that could be modified to generate lentiviral vectors for different therapeutic genes, such as CD-19 CAR-T and BCMA CAR-T.

From a production standpoint, the resulting cell line enabled large-scale development akin to monoclonal antibodies and therapeutic proteins.

Eliminating the need for GMP production for multiple plasmids, this breakthrough ensured continuous expression of viral packaging, leading to increased production efficiency, enhanced product quality consistency, and significantly reduced costs.

Although the laboratory-level construction of these cell lines occurred over a decade ago, the industrialization and commercialization of the technology only happened in 2022, after Dr. Jian Dong, the CSO of the company, and his team’s sustained efforts in industrial technological innovation involving various transfection methods and tool combinations.

“We offer tools to boost universal cell therapy, where we prioritize focus and patience in exploring the wide range of applications in mesenchymal stem cells (MSC) and natural killer (NK) cell-based treatments,” says Baowen Chen, CEO and chairwoman of Shanghai LIFE. “For lentiviral vector-based CGT, we place innovation at the forefront, addressing manufacturing cost challenges and reshaping the overall gene therapy landscape.”

Shanghai LIFE empowers the development of stem cells, immune cells, and gene therapy products powered by lentiviral vectors. Its LF-ToolBox CGT technology and platform help researchers align their assays with IND applications, clinical trial requirements, and national environmental policy standards.

In CGT manufacturing, the LF-ToolBox has successfully broken barriers to offer high viral titers, low batch-to-batch variability, high standardization, and lower production costs. Its potential impact is considerable, with the promise of an 80 percent reduction in the prices of gene therapy products, including CAR-T and CAR-NK therapies.

Shanghai LIFE has three novel drugs currently in various stages of clinical research, with one of them, MSC therapy for idiopathic pulmonary fibrosis (IPF), currently in Phase II clinical trials. A case exemplifying the latter’s impact involved recruiting a 56-year-old woman into the IPF study. The patient was suffering from the disease for an extended period, enduring significant breathing difficulties and limited mobility. Within three weeks of administering a bronchoscopic injection containing the single, lowest dose (only 10 percent of the proposed dosage) of Shanghai LIFE’s product, her daily life witnessed a remarkable improvement, marked by a significant ease in breathing. She regained the ability to independently manage household chores and partake in leisure activities.

Successes like this underscore the company’s commitment to improving patient lives. With a collaborative R&D team and innovative technologies, Shanghai LIFE is leading the charge in revolutionary CGT advancements, paving the way for better treatment modalities and a brighter future in healthcare.