Turn-Key Service
A one-stop solution that covers the design, construction, operation, maintenance, and technical services for cell production in a miniature intelligent cell preparation plant meets customer needs for immune cells, stem cells, and exosomes.
The highly integrated modular design and exclusive efficient processes allow for economically beneficial cell production in small spaces, even within conventional hospital structures.
YJ Biotech is actively collaborating with medical institutions domestically and internationally to create a decentralized clinical cell manufacturing model. This approach aims to address end-to-end logistics challenges in cell product delivery, providing medical institutions' clients with an enhanced cellular therapy experience.
Building Your Cell Production Base from Scratch
High-standard quality testing and safety assurance
An experienced and highly skilled team, advanced instruments, and data analysis ensure high-quality and accurate testing services, providing you with the best quality control for your products.
| Item | Method |
|---|---|
| Endotoxin Test (Kinetic Chromogenic TAL) | TWP (3085) Endotoxin Test、USP<85>Bacterial Endotoxins Test |
| Mycoplasma test (qPCR) | TWP (5063) Mycoplasma test |
| MSC surface marker detection | Flow Cytometry CD44+/CD73+/CD90+/CD105+ CD34+/CD45+/CD11b+/CD19+/HLA-DR+ |
Development and manufacturing services are entrusted to YJ Biotech
Manufacturing services for stem cells and immune cells, delivering the highest quality cellular products.
Develop hardware and software processes, as well as quality inspection methods, according to specific requirements.
Provide mass production of exosomes, sterile filling, and pharmaceutical-grade lyophilization services.
Our design focuses on user experience and production efficiency. It integrates all essential elements of the cell processing into an A-grade cleanroom, including an RTP quick-connect incubator, hydrogen peroxide sterilizer, vaporizable optical microscope, and high-capacity centrifuge.
The interior of our isolator is constructed with 316L medical-grade stainless steel, and an ISO 5 clean environment is created using an H14 HEPA filter. The digitalized environmental monitoring data and real-time recording ensure traceability throughout the entire cell production process, complying with FDA 21 CFR Part 11 regulations.
We have made the first MIT pharmaceutical isolator, which is tailor-made for cell manufacturing in compliance with PIC/S GMP standards.
We also provide sterile process equipment for cell formulations: cell culture incubator, aseptic filling equipment, pharmaceutical-grade freeze-dryer, and vaporized hydrogen peroxide sterilization equipment (VHP).
BEST MANUFACTURING PARTNER
The TFDA has issued the "Regulations Governing the Application or Use of Specific Medical Techniques or Examinations, or Medical Devices” (hereinafter referred to as the "Regulations of Special Medical Techniques”). It has amended the articles to include six cell therapy technologies. These technologies, including autologous immune cell therapy, are applicable to individuals with cancer who have not responded to standard treatment and those in the late stages of solid tumors.
Autologous Immune Cell Therapy (CIK)
Stage IV Solid tumors: Breast cancer, Lung cancer, Colorectal cancer, Liver cancer, Gastric cancer, Ovarian cancer
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