Yung-Che Kuo, Ph.D.
TMU Research Center for Cell Therapy and Regeneration Medicine,Taipei Medical University, Taipei, Taiwan

CDMO Process Development for CAR-T and Other Immune Cell Therapy Products

As chimeric antigen receptor T cell (CAR-T), universal CAR-T (UCAR-T), CAR-natural killer (CAR-NK), T cell receptor-engineered T cell (TCR-T), tumor-infiltrating lymphocyte (TIL), and other immune cell therapy products progressively advance from bench research toward clinical trials and commercial manufacturing, the cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) industry in China is no longer limited to a conventional contract-manufacturing model. Instead, it is gradually evolving into an integrated service model covering technology transfer, process development, analytical method development, Good Manufacturing Practice (GMP) manufacturing, quality testing, Investigational New Drug (IND) application support, and commercial scale-up.

Taking Porton Advanced as an example, according to its official materials, Porton Advanced is positioned as an end-to-end clinical research organization (CRO) and CDMO platform for gene and cell therapy, with services covering technology transfer, non-registrational clinical sample manufacturing, process development, analytical method development, cGMP manufacturing, testing services, IND application support, and New Drug Application (NDA) support. Its stated service scope also explicitly covers a diverse range of cell and gene therapy products.

Regarding CDMO process development experience for CAR-T and other immune cell therapy products, Porton Advanced and OBiO both demonstrate relatively broad product coverage and clinical translation experience.

Since establishing its first cell therapy cGMP production line, Porton Advanced has secured 26 global IND approvals from the NMPA, FDA, and Medsafe, with 12 ongoing Phase I/II advanced therapy medicinal product (ATMP) projects. Its official CDMO case portfolio also includes EpCAM CAR-T, B7-H3 CAR-T for glioma, NKG2DL CAR-T for solid tumors, TCR-T, and other projects. OBiO states that its CGT CDMO services can support technical research, process development, and GMP manufacturing for CAR-T, UCAR-T, NK, CAR-NK, γδ T cell, TIL, regulatory T cell (Treg), and dendritic cell (DC) therapy products. These examples suggest that OBiO’s platform positioning is not restricted to a single CAR-T product but extends to multiple categories of immune cell therapies.

Viral Vector and Plasmid DNA Supply as a Critical Bottleneck

The availability of viral vectors, including lentiviral vectors, as well as plasmid DNA, remains a critical bottleneck for the stable progression of CAR-T and other genetically modified cell therapy products into clinical trials. According to OBiO’s official materials, its gene therapy CDMO services cover adeno-associated virus (AAV), lentiviral, and adenoviral vectors and can also support major gene therapy products, such as plasmids, oncolytic viruses, and CAR-T products. Its viral vector process development integrates high-throughput process development, Design of Experiments (DoE), and Quality by Design (QbD) concepts, and the company has accumulated hundreds of process development reports including plasmids, lentiviral vectors, AAV, multiple oncolytic viruses, and CAR-T cell therapy products.

ProBio, the CDMO arm of GenScript, positions itself as an end-to-end CDMO service provider from drug discovery to commercialization, covering biologics, cell and gene therapy, plasmids, viral vectors, and mRNA vaccines. The company reports that, since 2017, it has supported more than 150 IND approvals across the United States, Europe, and the Asia-Pacific region. In addition, ProBio signed a memorandum of understanding (MOU) with the Korean CAR-T company Curocell for viral vector manufacturing, including the development, production, and clinical trial support of viral vectors required for next-generation CAR-T therapies. ProBio’s announcement also directly notes that shortages in GMP viral vector facilities may delay the development of CAR-T and other gene therapies.

GMP Manufacturing Challenges for Autologous and Allogeneic Immune Cell Therapy Products

The GMP manufacturing challenges for immune cell therapy products primarily lie in focusing in batch-to-batch variability, closed-system operations, cleanroom configuration, cross-contamination control, and flexible production capacity. According to Porton Advanced’s official materials, the company operates multiple closed-system cGMP production lines. These lines are designed to support autologous cell products, allogeneic cell products, and various cell therapy products that require extensive closed-system operations. Its autologous cell production lines are equipped with automated separation, culture, and concentration systems, and each production line is configured with Grade B and Grade A cleanrooms for modularized cGMP production. Hillgene also emphasizes that its HiCellx® platform is a fully closed and automated cell process development platform, enabling flexible adaptation to the production and testing requirements of different cell products. These examples suggest that CDMO providers in China are responding to the manufacturing challenges of autologous and universal cell therapy products through closed-system and modularized manufacturing strategies.

In the context of digitalized manufacturing, automation, closed-system platforms, and single-use processing technologies have become clear trends in the industry. OBiO states that it has developed a fully closed and automated purification process using single-use production equipment for end-to-end closed pipeline operations. This approach is intended to improve purification efficiency and aseptic manufacturing capability while achieving high throughput, high yield, and high-quality assurance. Hillgene highlights its HiCellx® fully closed cell platform, HiLenti® suspension serum-free lentiviral platform, and HiPlas™ nucleic acid platform, and further states that its closed cell platform is applicable to the manufacturing of both autologous and universal cell products. Therefore, based on public official information, the current focus of CDMO industry for immune cell therapy in China is not merely the expansion of production capacity. Rather, the industry is building comprehensive infrastructure that supports CAR-T and next-generation immune cell therapies from early -development to commercial manufacturing through the integration of closed systems, automation, single-use technologies, DoE, QbD, CMC (Chemistry, Manufacturing, and Controls) strategies, and international regulatory submission experience.

Industry Development Trends

The development trajectory of CGT CDMO industry in China is shifting from single-point service provision toward multifaceted, cross-platform, cross-regional, and internationalized one-stop solutions. In its 2026 official announcement, Porton Advanced stated that it had established a strategic collaboration with T&L Biotechnology to provide global CGT clients with an integrated and seamless solution spanning core raw materials, process development, and scale-up manufacturing. The same announcement also stated that Porton Advanced had established CRO/CDMO platforms for plasmids, viral vectors, cell therapy, gene therapy, and nucleic acid therapeutics. The company had also built 10 viral vector production lines and 12 GMP cell therapy production lines, and had also helped clients obtain clinical trial approvals in China, the United States, New Zealand, and other countries. Hillgene also states that its platforms have supported multiple CAR-T, TCR-T, CAR-NK, and hematopoietic stem cell (HSC) products and have obtained more than 24 clinical trial approvals from different regulatory agencies, including the NMPA, EMA, and FDA. These developments indicate that Chinese CDMO companies have begun to position global supply capabilities and multiregional regulatory submission experience as core competitive advantages.

Conclusion

In summary, China’s CAR-T and immune cell therapy CDMO industry is at a critical transition point, moving from rapid expansion toward higher quality standards and international competitiveness. In the future, as process standardization, quality systems, and cross-regional regulatory experience continue to mature, Chinese CGT CDMO providers with integrated platform capabilities and global service networks will be better positioned to play important roles in the global cell and gene therapy value chain. These capabilities may further accelerate the clinical translation and commercialization of next-generation immune cell therapies.

Disclaimer

This article was compiled and written based on publicly available information from the official websites and related official materials of the companies mentioned above. The summarized public information is intended solely for academic discussion and reference. Although the authors have made every effort to verify the content, all data and descriptions should ultimately be interpreted according to the most recent updates issued by the original publishing organizations.