In the sophisticated world of cell therapy and exosome drugs, the stability of every link is related to the hope of life. With the rapid development of advanced therapeutic drugs (ATMPs) such as CAR-T, stem cell therapy and exosome drugs, the scientific selection of packaging materials and the compliance of production processes have become the core challenges of industrialization. With its unique material properties, COP vials are reshaping the filling, storage and declaration standards of cell therapy drugs and exosomes, providing solutions that are both safe and efficient for the ATMP field.
Polymer Vial 2ml 5ml 10ml for cell and gene therapies
1. COP material: the "golden container" of cells and exosomes
The core advantages of COP vials come from its material properties:
Chemical inertness and low adsorption
Highly tolerant to acids, alkalis and organic solvents, avoiding reactions with active substances such as viral vectors and cytokines; protein adsorption rate <0.05 μg/cm² (much lower than >0.3 μg/cm² of freezing bags), significantly reducing the loss of therapeutic proteins (such as IL-2).
Extreme temperature adaptability
Withstands temperatures from -196°C (liquid nitrogen) to 121°C (autoclaving), ensuring stability throughout the entire process from cryopreservation to aseptic filling.
Regulatory safety
Meets USP Class VI and EP 3.1.5 standards, with extremely low levels of extractables (TOC < 500 ppb), preventing impurities from interfering with cell activity. Data comparison: The survival rate of T cells stored in COP vials after thawing is > 90%, while that of traditional glass vials is only 85%.
2. Filling process: closed system and aseptic control
The filling of cell therapy drugs and exosomes must meet the triple standards of closure, precision and asepticity:
Closed filling: Aseptic filling is achieved by irradiation sterilization gamma ray pre-sterilization COP vials. The case shows that no mycoplasma/endotoxin was detected in 10 mL of AAV gene therapy products;
Automation compatibility: The rigid bottle body is adapted to the robot arm grasping (positioning accuracy ±0.1mm), and the filling efficiency can reach 500 bottles/hour;
Real-time sterilization technology: integrated ultraviolet light irradiation filling head to avoid contamination of exosome oral liquid during filling (reference to the design of exosome filling device of traditional Chinese medicine).
3. Low temperature storage: cross-temperature stability solution
The low temperature resistance of COP vials makes it an ideal carrier for cross-temperature storage:
Freezing protection: long-term storage of CAR-T cells in liquid nitrogen, the proportion of CD3+ cells remains >95%;
Cold chain transportation design: COP vials are embedded in customized cold chain boxes containing phase change materials, supporting transportation from -150℃ to 25℃, and temperature fluctuations <±2℃. Compared with traditional freezing bags, the compressive strength is >50 MPa, can be stacked for transportation and is not easy to break, reducing the risk of cell loss during liquid nitrogen transportation.
4. Policy declaration: Compliance path under the ATMP regulatory framework
In 2025, the National Medical Products Administration's "Scope, Classification and Interpretation of Advanced Therapeutic Drugs" clearly included exosomes in the ATMP regulatory system, requiring:
Classification supervision
Non-genetically modified cell drugs (such as mesenchymal stem cells): declared as CTMPs;
Exosome drugs: need to prove "active ingredients + therapeutic function" and complete GMP standardized production system verification.
Process compliance
Exosome separation requires the use of GMP-grade processes such as tangential flow filtration (TFF) or molecular exclusion chromatography, and the impurity removal rate must reach more than 97%; the filling process must comply with the aseptic requirements of the Good Manufacturing Practice for Pharmaceuticals (GMP).
Clinical positioning
Indications must be precise (such as exosomes for skin repair and ovarian activation) to avoid confusion with nutritional health products.
COP vials are not only containers, but also key media connecting technological innovation and clinical implementation. Its low adsorption ensures drug activity, its temperature resistance supports full-link stability, and its closed design fits the regulatory soul of ATMP. With the launch of two CAR-T drugs in my country and the inclusion of exosomes in the ATMP system, COP technology will accelerate cell therapy from "individualized exploration" to "standardized production", paving a new path for more patients on the dual tracks of regulation and science.
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