Sino Biological has the capability to produce GMP-grade cytokines which can play huge roles into cell therapy and clinical applications research.
Sino Biological has managed to successfully create a portfolio of GMP-grade cytokines with the help of a GMP-grade quality management system. This system uses excellent quality management and liberating testing criteria.Cytokines - low molecular weight proteins or minor polypeptides - play significant roles in transmitting data between cells and controlling immune responses and effector functions, such as the promotion of cell proliferation and growth and tissue repair.
In basic research in life sciences, they are widely utilized, as well as in cancer immunotherapy, regenerative medicine, stem cell therapy, and chimeric antigen receptor-T cell /natural killer cell preparation, and culture. Thus, stricter standards and regulations have been set to guarantee the safety of cytokines.
GMP-grade cytokines have been manufactured in accordance with GMP standards, which involve a strict quality management system, standardized quality assurance management, and quality control system. Such systems have been developed to reduce uncertainty and variability in the manufacturing process, thereby ensuring high quality of cytokine products.Unlike recombinant drugs, GMP-grade cytokines cannot be directly used for disease treatment but can serve as excipients for cell therapy. Although GMP-grade cytokines do not need approval from the United States Food and Drug Administration, during production, strict compliance with GMP is mandatory.
For cell therapy research and clinical applications, Sino Biological is devoted to manufacturing high-quality reagents. By applying a quality management system that sticks to GMP standards, and implementing rigorous quality management and liberate testing criteria, Sino Biological has successfully made a range of high-quality GMP-grade cytokines.
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