How To Move Beyond Empirical Cell Culture? Immune Cell Therapy Enters The 2.0 Era

Broad Prospects and Severe Challenges of the 2.0 Era

Immunotherapy has become the fourth major cancer treatment modality following surgery, radiotherapy, and chemotherapy, among which adoptive cell therapy (ACT) occupies a dominant position.

 

CAR-T Cell Therapy: Breakthrough progress has been achieved in hematological malignancies. Since the approval of the first drug in 2017, multiple products have been marketed globally, and the technology has advanced to the fifth generation, mainly indicated for the treatment of B-cell lymphoma, acute lymphoblastic leukemia, etc.TCR-T and TIL Therapies: Significant potential has been demonstrated in the field of solid tumors. In 2024, the world's first TCR-T therapy was approved for the treatment of soft tissue sarcoma; in the same year, the first TIL therapy was also approved for advanced melanoma, marking a new stage in solid tumor treatment.

 

Although modern immunology has only developed for over a century, immunotherapy has evolved into an indispensable approach in cancer treatment after decades of advancement. Its broad prospects stem from the inherent high complexity of the immune system. However, while cell therapy demonstrates enormous potential, it still faces significant common challenges: most current clinical studies remain in Phase I or II, with relatively few Phase III trials. Issues such as long cell preparation cycles, high costs, difficulty in standardization, and suboptimal efficacy in solid tumors have severely restricted its wider clinical application.

 

Key to Breaking the Dilemma: Technological Innovation and Industrial Innovation

In the face of these challenges, the report points out that the key to breaking the dilemma lies in two major technical pillars: novel target discovery and manufacturing process innovation. Regarding targets, neoantigens are the "unique identifiers" of tumors, enabling precise cancer treatment. Personalized vaccines and cell therapies based on neoantigens represent important future directions. Meanwhile, the key to improving treatment accessibility lies in process innovation, which makes it possible for advanced cell therapies to evolve from "luxury treatments" to "affordable healthcare." Advanced manufacturing processes are central to breaking industrialization bottlenecks, and this is inseparable from a core foundation-a safe, efficient, and stable cell culture system.

 

Traditional immune cell culture methods suffer from problems such as long preparation cycles, high costs, and difficulty in standardization. The serum used in the culture process has complex components and significant batch-to-batch variations, posing potential risks that restrict the quality of cell products and the stability of production processes. BioEngine's HIPP series of serum-free media for lymphocytes is precisely the solution to this industry pain point. Developed specifically by BioEngine for immune cell culture, the HIPP series can support the efficient expansion of immune cells under completely serum-free conditions while maintaining excellent cell viability and functional indicators. Currently, the HIPP series products have successfully supported multiple cell therapy projects to enter the clinical stage, making them an ideal choice for the cell therapy field from research and development to commercial production.

 

Product Features：

Safe Composition: Xeno-free, free of exogenous cytokines, synthetic activators, and additives with unknown components.Broad Applicability: Supports serum-free culture of primary cells (e.g., T cells, NK cells, CAR-T, CAR-NK, CIK, TIL, γδT, HSC (CD34+)) and various cell lines (e.g., NK-92, NK-92MI, K562, Jurkat).

Flexible Process Compatibility: Adaptable to both R&D and production stages, compatible with multiple culture formats including well plates, flasks, culture bags, and wave bioreactors.

High Performance: High expansion fold, cell viability >95%, high CAR positivity rate, excellent memory phenotype, and low exhaustion phenotype.

 

Why Choose the HIPP Series?

Uncompromised Expansion Efficiency: The fully serum-free culture system exhibits superior cell expansion efficiency compared to traditional serum-containing systems across multiple projects.

Superior Cell Phenotype: Sustained cell viability >95%, ensuring optimal functional phenotypes (high CAR positivity rate, low exhaustion phenotype, and high memory phenotype).

More Stable Culture Process: Eliminates the need for serum, plasma, or serum substitutes, eradicating batch-to-batch variations at the source and guaranteeing reliable and consistent culture results.

Regulatory Compliance Support: Strictly adheres to GMP, ISO 13485, and MDSAP quality system requirements. Provides complete, authentic, and traceable data, with extensive experience in supporting clinical regulatory submissions.

 

Applied in cell therapy projects across multiple clinical trial phases:

2024: Supported a leading domestic cell therapy company's CAR-T project to successfully advance to the Biologics License Application (BLA) phase (HIPP-T009).

2019: Facilitated China's first tumor neoantigen-targeted cell therapy project to complete the Investigational New Drug (IND) application and enter clinical trials (HIPP-T009).

 

Product Performance：

1.T Cell Culture: HIPP-X100 outperforms other brands significantly in terms of expansion rate, cell viability, TSCM/Naive T cell phenotypes, and exhaustion phenotype. When culturing T cells under fully serum-free conditions, the expansion fold of HIPP-X100 is 66% and 23% higher than that of other brands (Day 11), while maintaining a high viability of over 97%. Meanwhile, flow cytometry results show that the positive rate of CAR-T cells is 72%, which is 47% and 12% higher than that of other brands, respectively.

Flow cytometry results showed that the positive rates of exhaustion phenotype markers (PD-1, TIM-3, and LAG-3) were 20%, 66%, and 34%, respectively, which were comparable to those of other brands. The proportion of stem cell-like memory T cells (TSCM) or Naive T cells with the CD45RA+/CD62L+ phenotype was 68%, representing a 13% and 11% increase compared to other brands, respectively; the proportion of CD45RA+/CCR7+ was 69%, which was 53% and 13% higher than that of other brands, respectively.

 

2.NK Cell Culture: The serum-free system of HIPP-T009 outperforms serum-containing protocols significantly. In feeder layer-based NK cell culture, the serum-free medium of Brand A fails to support effective NK cell proliferation. In contrast, HIPP-T009 enables efficient NK cell expansion under fully serum-free conditions, and its expansion efficiency is even significantly superior to that of Brand A medium supplemented with 5% serum, with a 27% increase in expansion fold on Day 14. Flow cytometry results show that the CD3-/CD56+ ratio in HIPP-T009 is 68.9%, which is comparable to that of serum-containing culture.