Breaking Through the Bottleneck of Cell Therapy Scale-up: FEP Materials Lead the New Wave of Fully Closed Automated Production
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Breaking Through the Bottleneck of Cell Therapy Scale-up: FEP Materials Lead the New Wave of Fully Closed Automated Production
Views: 0 Author: Site Editor Publish Time: 2025-11-21 Origin: Site
As a cutting-edge direction in the biomedical field, cell therapy focuses on manipulating human-derived cells in vitro and reinfusing them into the human body for disease treatment. Compared with traditional methods such as chemotherapy and radiotherapy, cell therapy enables precise intervention targeting diseased cells (e.g., CAR-T cells specifically recognizing tumor antigens) while avoiding systemic toxicity. Thus, it has demonstrated clinical advantages of "precise targeting and low side effects" in overcoming intractable diseases such as tumors and tissue damage repair. By 2025, dozens of cell therapy drugs have been approved for marketing worldwide, covering hematological tumors, solid tumors, neurodegenerative diseases and other fields.
Global Approved Product Landscape: Immune Cell and Stem Cell Therapy Advancing Hand in Hand
Approved immune cell therapy drugs: 18 products, mainly CAR-T products, dominating the treatment of hematological tumors.
Approved hematopoietic stem cell and mesenchymal stem cell drugs: 24 products, widely used in tissue repair, immune regulation and other fields. Among them, 11 are hematopoietic stem cell drugs and 13 are mesenchymal stem cell drugs.
Technically, cell therapy is mainly divided into two categories: immune cell therapy and stem cell therapy. Immune cell therapy (e.g., CAR-T) focuses on "modifying" immune cells to enable them to accurately kill diseased cells; while stem cell therapy utilizes the "regenerative" and "repair" properties of stem cells to reconstruct damaged tissues. Despite different approaches, both face a common core challenge in industrialization: how to achieve large-scale, standardized expansion of high-quality cells.
What are the Industry Bottlenecks? Large-scale Preparation of High-quality Cells
Currently, traditional manual culture methods have become a bottleneck restricting industry development due to low efficiency, high contamination risk, and significant batch-to-batch variation. Therefore, upgrading to a fully closed and automated culture system has become an inevitable trend. In this transformation, the core innovation of the process foundation lies in replacing traditional open culture flasks with fully gas-permeable closed culture bags.
Cell culture bags are made of polymer materials, equipped with multiple sterile ports to support medium perfusion, sampling and cell harvesting. They have good oxygen permeability and are easy to integrate into closed automated production lines. Their structure is usually a flexible "top + bottom" gas-permeable design, which can effectively reduce water evaporation while maintaining good gas exchange, keeping the culture environment stable. In contrast, traditional polystyrene culture flasks are open systems that rely on vented caps for gas exchange, which easily leads to medium evaporation and increased contamination risk. In suspension cell culture, cell culture bags show significant advantages: they can achieve high-density cell expansion with more harvested cells; fully closed operation greatly reduces the probability of contamination; flexible and customizable specifications support linear scaling from process development to large-scale production, providing a standardized and scalable solution for the cell therapy industry.
Material Evolution: Why is FEP a Better Choice?
Among numerous commercially available culture bags, traditional EVA (ethylene-vinyl acetate copolymer) materials are widely used, but they have limitations such as relatively insufficient water retention and gas permeability, easy breakage, and potential trace leachables. In contrast, FEP (hexafluoropropylene-tetrafluoroethylene copolymer) is increasingly becoming the ideal choice for high-standard cell culture due to its excellent material properties, especially suitable for the production of key therapeutic products such as CAR-T and NK cells.
The advantages of FEP stem from its unique materials science:
Excellent chemical stability: Rich in high-energy C-F bonds, resistant to strong acids, strong bases and organic solvents, maintaining transparency without discoloration or degradation during long-term use.
Low surface energy: Symmetrical molecular structure, weak polarity, low surface energy (18 dyn/cm), and not easy to adsorb impurities.
High transparency: Amorphous structure, low light scattering, refractive index close to water (about 1.34), and clear imaging.
Biological inertness: Stable properties, no adsorption of biomolecules such as proteins and growth factors, and no release of harmful substances.
Water retention and bacteriostasis: Low water vapor transmission rate, reducing medium evaporation; low surface energy inhibits bacterial adhesion and reduces contamination risk.
Wide temperature tolerance range: Maintains flexibility between -196°C (liquid nitrogen) and +137°C (autoclaving).
Biocompatibility certification: Passed FDA and USP Class VI certifications, suitable for long-term culture of sensitive cells such as stem cells and primary cells.
These properties make FEP culture bags a key upstream material that complies with GMP standards and supports closed workflows.
Solution: Innovation and Practice of Yocon's FEP Culture Bags
As an enterprise focusing on the upstream of cell therapy, Yukang Bio has successfully overcome the technical challenges of laser welding for FEP materials, developed a new type of FEP cell culture bag, and obtained US FDA DMF filing (Filing No.: 041754), providing a safer, more efficient and standardized production solution for the global cell therapy industry.
Product forms include manual culture bags and automated culture bags based on FEP closed pipeline systems (to be used with Yocon's fully automated cell culture workstation).
Product Advantages
The closed cell culture system can provide a suitable environment for cell expansion while minimizing the risk of cross-contamination.
Large gas exchange area, enabling more cells to be obtained within the same culture time.
Material light transmittance of over 95%, facilitating better evaluation of cell growth status and ensuring cell safety.
FEP is a 100% inert material that maintains flexibility between -196°C (liquid nitrogen) and +137°C (autoclaving). It is a single-layer high-purity material with no cell or tissue toxicity and excellent biocompatibility.
The sophisticated laser welding technology solves the potential leakage problem of cell culture bags, ensuring maximum sealing integrity.
