Shenzhen SynGen Bio Launches China's Only Commercially Available Fully Closed Automated Cell Processing System to Drive Cost Reduction and Efficiency in CGT

From the perspective of pharmaceutical development history, we have experienced the era of small-molecule drugs and the era of large-molecule drugs. In the future, emerging cellular and gene therapies (CGT) may well follow suit, becoming the third major pillar of the pharmaceutical industry.

Benefiting from policy support such as the “Technical Guidelines for Clinical Trials of Immune Cell Therapy Products (Trial)” and the “Technical Guidelines for Pharmaceutical Research and Evaluation of Gene Therapy Products (Draft for Comments),” China’s CGT industry has achieved a globally leading position. Between 2017 and 2019, more than 1,000 clinical trials were initiated or ongoing in China, and the national government granted thousands of related patents, ranking second worldwide.

According to Frost & Sullivan, the global CGT market size is projected to reach $30.54 billion in 2025, with a compound annual growth rate (CAGR) of 71% from 2020 to 2025. China’s CGT market is expected to maintain rapid growth, with its total market size reaching $2.59 billion in 2025 and a CAGR of 276% from 2020 to 2025.

However, the CGT industry is currently facing several pain points in its development. In the early stages, the primary concern for CGT was therapeutic efficacy. As the industry has matured and more products have reached the market, the focus has shifted from initial efficacy to ensuring consistency in manufacturing and controlling final costs. The high prices of gene and cell therapies are largely driven by their production costs. Therefore, reducing these costs will be a key factor in enabling the widespread adoption of these therapies. Consequently, the CGT CDMO/CRO sector is poised to become a prominent area for future growth.

Pricing of Select Gene and Cell Therapies

Shenyan Biologics is a company focused on upstream supply for CGT., co-founded by Ma Mo and Xue Bofu in 2014. During their university years, one founder majored in automation while the other specialized in biotechnology. The two frequently discussed the possibility of integrating their respective disciplines—automation and biotechnology—to embark on a high-barrier entrepreneurial venture focused on interdisciplinary, cutting-edge technologies. Thus, Shenyan Biology was born.

In addition to the two founders’ interdisciplinary backgrounds, Shenzhen Shenyan Biological Technology Co., LTD is overall a multidisciplinary, R&D-driven team, with R&D personnel accounting for more than 70% of its workforce.Shenzhen Shenyan Biological Technology Co. LTD has completed the research and development of a series of core technologies and processes in Cell and Gene Therapy (CGT) by leveraging interdisciplinary integration and technological innovation across computer science, electronic engineering, nanomaterials, chemical engineering, and life sciences, thereby propelling biotechnology R&D into the era of automation and informatization.

Shenzhen Shenyan Biological Technology Co., LTD achieves fully closed, automated manufacturing of cell therapy products through the research and development of key technologies and core processes in the field of Cell and Gene Therapy (CGT). This approach not only mitigates the risks of contamination and cross-contamination, ensuring a safe, effective, and quality-controlled production process, but also enhances the production efficiency of cell-based products. Furthermore, it increases the success rate of both clinical and commercial manufacturing, while reducing the capital and operational costs associated with Good Manufacturing Practice (GMP) facility construction and operation. Consequently, this lowers the overall cost of cell preparation, addressing critical bottlenecks in the development of the cell therapy industry.

Shenyan Bio’s R&D platform is currently focused on developing core technologies in the field of gene and cell therapy. Taking lentiviral vectors, which are widely used in gene and cell therapy, as an example, traditional transient transfection-based production methods suffer from pain points such as complex processes, low yields, inconsistent quality, difficulties in scale-up, and high overall costs. Shenyan Bio has innovatively developed a lentiviral vector production system based on stable cell lines, breaking through the technical bottlenecks associated with large-scale lentiviral vector manufacturing. This advancement significantly enhances production efficiency and product consistency while substantially reducing production costs, bringing about a revolutionary change to lentiviral vector production.

Unlike the aforementioned two R&D platforms, which focus on the development and commercialization of technological products, Shenyan Bio’s internal bio-automation R&D platform is designed for in-house use. By empowering internal operations with automation, it accelerates the iteration speed and efficiency of Shenyan Bio’s biotechnological advancements, thereby facilitating breakthroughs in core biotechnologies.

Based on the two major platforms, Shenzhen Shenyan Biological Technology Co. LTD currently has two core products under development. One of its core products is CellSep PRO (abbreviated as CSP), launched based on the automated equipment R&D platform,This product is currently the only domestically produced, fully automated, closed-cell processing system on the market. It is suitable for the standardized manufacturing of various cell therapy products, including CAR-T, TCR-T, NK cells, and bone marrow stem cells. This equipment has broken the monopoly held by imported devices in the market, providing a viable solution to reduce the production costs of cell-based therapies.

CSP is a fully closed, automated cell processing system independently developed by Shenzhen Shenyan Biological Technology Co., LTD. Leveraging the principle of gradient centrifugation and utilizing single-use closed tubing, it performs procedures such as separation, enrichment, concentration, washing, buffer exchange, and dilution. CSP enables a range of standardized and customized cell preparation processes, including PBMC isolation, magnetic bead incubation and washing, lentiviral centrifugal transduction, cell suspension concentration and washing, and aliquoting of cell products into bags. Furthermore, CSP can accommodate various other processes, such as cell thawing, umbilical cord blood separation, bone marrow separation, platelet depletion, and component blood separation.

Based on the aforementioned manufacturing process, CSP enables automated production to ensure high product consistency, reduces GMP facility construction and operational costs, increases GMP utilization by more than tenfold, and cuts the number of production personnel by 90%, thereby effectively reducing costs.

Another core product developed by Shenzhen Shenyan Biological Technology Co., LTD is the EuLV system, a lentiviral vector production system based on stable cell lines. This system utilizes inducible stable producer cell lines to manufacture lentiviral vectors through high-cell-density suspension culture in chemically defined media. The EuLV lentiviral vector production system enables induced production without the need for plasmid transfection. It stably integrates the genes encoding VSV-G, gag/pol, rev, and the gene of interest (GOI) into the genome of 293T cells, followed by drug-induced expression to produce lentiviral vectors. This technology breaks through existing viral vector production methods, achieving innovation and leadership in viral vector production technology for China’s gene and cell therapy industry.

This technology offers advantages such as being plasmid-free, inducing toxin production, ensuring high consistency of lentiviral vectors, achieving a transfection titer of up to 5.3E8 TU/ml in crude culture medium, and attaining a viral specific activity of 1/10. It reduces production steps by more than 50%, increases production efficiency by 100-fold, and lowers costs by over 80%. By producing lentiviral vectors via the EuLV system, substantial cost reductions and process improvements for cell and gene therapy (CGT) are achieved at the source of vector preparation.

Based on these three major technology platforms and two core products, Shenzhen Shenyan Biological Technology Co. LTD will continue to dedicate itself to providing cost-controllable, stable, and reliable automated and informatized CGT processes. By integrating the development of multiple interdisciplinary fields, we significantly reduce process operational complexity and production costs starting from upstream supply, thereby enabling people in China to access affordable CGT solutions.

Regarding current developments, Ma Mo stated, “The emergence of new technologies requires a continuous influx of talent. This is especially true in multidisciplinary fields with high barriers to entry, which demand collaborative R&D efforts from professionals across various disciplines. Additionally, securing upfront investment for technology development is a critical need for startups. Previously, Shenzhen Shenyan Biological Technology Co., LTD completed two rounds of financing totaling tens of millions of yuan, with investors including DJI Innovations, Yuanchuangli Qingyuan Fund, Xiaoming Investment, and a well-known international strategic investor. Moving forward, Shenzhen Shenyan Biological Technology Co., LTD will pursue comprehensive growth by expanding its team, attracting additional investors, and strengthening industry partnerships to accelerate technological iteration.”

However, the development of new technologies is always subject to uncertainties and shifting trends. When asked about the key priorities for future development, Ma Mo stated: “The future trajectory of emerging fields is inherently unpredictable; however, addressing the critical pain points and unmet needs within the industry remains the cornerstone of our sustained development. In the current landscape of Cell and Gene Therapy (CGT), prohibitive treatment costs are the primary barrier preventing many patients and their families from accessing these therapies. Shenzhen Shenyan Biological Technology Co., LTD is strategically positioning itself across two key domains: the research and development of CGT equipment and consumables, and the provision of CGT CDMO/CRO services. Through this comprehensive layout, we aim to alleviate the industry’s pressing challenges and contribute to the advancement of automation and digitalization in biotechnology.”