Cell preparation isolation
2026-1-9
TELING Cell and Gene Therapy Isolator
Simplified isolator solution specifically designed for cell and gene therapy R&D, providing GMP-compliant aseptic operation environment
Product Overview
TELING provides a simplified isolator solution for cell and gene therapy R&D, specifically designed for laboratory professionals who need to handle sterile products under aseptic conditions. The system is carefully designed to allow safe manipulation of cell cultures in pharmaceutical environments compliant with GMP guidelines, with market authorization where applicable.
The isolator integrates typical laboratory instruments for analyzing and processing cell cultures, forming a complete workstation. The system operates under positive pressure relative to the laboratory, effectively maintaining the sterility of the internal environment, thereby ensuring product integrity and safety.
The isolator adopts a modular design concept, allowing flexible configuration according to different experimental needs and spatial conditions. The integrated intelligent control system features real-time environmental monitoring, data recording, and audit trail functions, complying with domestic and international cell therapy product quality management regulations.
Core Features
Aseptic Assurance
Provides a continuously stable aseptic operating environment through positive pressure and efficient filtration system, effectively preventing microbial contamination and ensuring the purity of cell cultures.
Integrated Design
Built-in typical laboratory instruments form a complete workstation, supporting analysis and processing of cell cultures, improving experimental efficiency.
GMP Compliance
Specifically designed for GMP-compliant pharmaceutical environments, supporting cell operations under market authorization conditions, meeting regulatory requirements.
Positive Pressure Environment
Operates under positive pressure relative to the laboratory, effectively preventing external contaminants from entering, maintaining internal environment sterility, and ensuring product safety.
Professional Design
Specifically designed for laboratory professionals, simplifying operational processes, lowering technical barriers, and improving accessibility of cell and gene therapy R&D.
Cell Specialization
Optimized design for the special needs of cell and gene therapies, supporting aseptic operation and processing of various cell cultures.
Technical Specifications
| Cleanliness Level | ISO Grade 5 (GMP Grade A) |
|---|---|
| Operating Pressure | Positive pressure design, maintaining positive pressure relative to laboratory environment |
| Airflow Pattern | Vertical laminar flow, wind speed 0.45±0.1m/s |
| Filter Configuration | H14 grade HEPA filters |
| Integrated Equipment | Typical cell culture laboratory instruments (microscope, incubator, etc.) |
| Control Method | Touchscreen control panel with data recording function |
| Compliance Standards | Meets GMP guideline requirements, supports market authorization environment |
| Application Fields | Cell therapy, gene therapy R&D and production |
Application Fields
Gene Therapy R&D
Provides aseptic operating environment for gene therapy product R&D, ensuring safe handling of gene vectors
Cell Therapy Production
Supports aseptic preparation and operation of cell therapy products such as CAR-T cells and stem cells
Regenerative Medicine Research
Provides GMP-compliant aseptic operation platform for tissue engineering and regenerative medicine research
Drug Screening
Supports cell-based high-throughput drug screening, ensuring aseptic conditions throughout the experimental process
R&D Phase Applications
In the R&D phase of cell and gene therapy drugs, TELING isolators provide a GMP-compliant aseptic operating environment for laboratory research. The system supports the entire process from basic research to preclinical studies, ensuring the professionalism and reproducibility of R&D data.
The integrated design reduces material transfer between equipment, lowering the risk of cross-contamination and improving R&D efficiency. The positive pressure environment ensures that sensitive cell cultures are not contaminated by the external environment during operation.
Production and Preparation Applications
In the production and preparation process of cell and gene therapy products, TELING isolators provide a GMP-compliant production environment. The system supports seamless transition from small-batch clinical sample processing to scaled production.
The positive pressure design and efficient filtration system of the isolator ensure that the production environment always meets Grade A cleanliness standards, providing assurance for the safety and efficacy of cell products.
Quality Control Applications
In the product quality control process, TELING isolators provide a safe environment for sterility testing and microbiological examination. The built-in data recording function supports audit trails, meeting regulatory requirements.
The simplified design of the isolator reduces operational complexity, making quality control processes more standardized and reproducible, improving the professionalism of test results.
Deployment Solutions
Research Institutions
Provides GMP-compliant aseptic operation platforms for universities and research institutes engaged in cell and gene therapy research, supporting basic research and translational research.
Medical Institutions
Deployed in hospitals and clinical research institutions, supporting the preparation of personalized cell therapy products, meeting the needs of clinical research and new drug trials.
Pharmaceutical Enterprises
Applied in the R&D centers and production lines of pharmaceutical enterprises, supporting the development and commercial production of cell and gene therapy drugs.
Compliance and Certifications
TELING Cell and Gene Therapy Isolator complies with domestic and international pharmaceutical production quality management regulations and related technical standards:
TELING isolator is specifically designed for GMP-compliant pharmaceutical environments, supporting cell operations under market authorization conditions. The system meets the special requirements of cell and gene therapy products, providing the necessary environment for the R&D and production of innovative drugs.
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