On May 16, 2024, under the support and guidance of the Chinese Society of Biomaterials, two anti-coagulant coating-related group standards led by Besaifei, T/CSBM 0046-2024 'In vitro test method for anti-coagulant performance of coatings' and T/CSBM 0047-2024 'Test method for anti-Xa/1a factor activity and content of heparin on the surface of medical devices' were officially released. Both standards were drafted by Dr. Li Dan, general manager of Baisaifei, and were drafted jointly by Jiangsu Baisaifei Biotechnology Co., Ltd., Baiinterface Interface Inspection and Testing Technology (Suzhou) Co., Ltd., Sichuan Medical Device Biomaterials and Products Inspection Center Co., Ltd., Shenzhen Institute of Drug Inspection (Shenzhen Medical Device Testing Center), Shandong Medical Device and Drug Packaging Inspection Institute and other professional research institutions and enterprises.
Blood contact medical devices are widely used in clinical practice, including vascular stents, artificial blood vessels, valves, vascular access products, blood purification products, ECMO, etc. Medical devices are allogeneic materials. When their surfaces come into contact with blood, they will activate the coagulation reaction by adsorbing proteins and platelets in the blood, thereby producing thrombi. Anticoagulant coating is an effective way to solve the problem of blood clots on the surface of medical devices. It has been developed abroad for decades. However, the application of anticoagulant coatings on domestic medical devices is still in its infancy. The evaluation of anticoagulant 4 coatings lacks scientific and unified method standards. As a result, there is no sufficient basis for in vitro evaluation during the design, development and registration review process of related medical devices, which greatly increases the cost of testing and zoological research.
As a leading company in the domestic medical coating industry, Baisaifei has been committed to developing internationally competitive medical coating products. The core R&D team has been deeply involved in the basic research and industrial applications of medical coatings for more than 20 years. It has established a comprehensive know-how system for functional coating principles and technologies, as well as various coating safety and effectiveness evaluation methods, and has obtained hundreds of downstream product application verification and recognition. Especially for anti-coagulant coatings, we were the first to launch the commercialization of domestic heparin coatings and phosphorylcholine coatings in China, and established a full set of in vitro evaluation methods for the performance of anti-coagulant coatings based on the application cooperation of various blood-contacting devices. After verification by multiple medical device inspection and testing institutions and companies, the two standards released this time were formed.
The 'In vitro test method for the anticoagulant performance of coatings' is based on the formation mechanism of thrombus on the product surface and the working principle of a typical anticoagulant coating. It recommends effectiveness evaluation methods at different levels from protein adsorption, platelet adhesion, coagulation activation to thrombus formation; the 'Test method for anti-Xa/1a factor activity and content of heparin on the surface of medical devices' for heparin anticoagulant coatings recommends a method suitable for quantitative testing of the content and activity of heparin fixed on the surface of the material. The above recommended methods have important guiding significance for the effectiveness evaluation of anticoagulant-coated devices.
The official release of two standards related to anticoagulant coatings not only fills the gap in domestic in vitro evaluation methods of anticoagulant coatings, but will also promote the development and marketing of devices with anticoagulant coatings. In the future, Besaifei will continue to leverage its professional advantages in the field of medical coating technology, continue to promote the standardization of coated device evaluation, and assist the high-quality development of domestic devices.
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About Baisaifei
Jiangsu Baisaifei Biotechnology Co., Ltd. is the leading domestic technical service platform for the entire industry chain of medical functional coatings, and is a leading enterprise and leader in the field of medical coatings. Based on the founder's more than 20 years of professional accumulation in the field of biomaterial surface interfaces and academic influence at home and abroad, it focuses on innovative research and development of biomaterial surface modification technology, and develops high-end functional coatings and related products with independent intellectual property rights and international competitiveness. Since its establishment, the company has gone through several expansions and four rounds of financing, and now has more than 30,000m of R&D and production space. It has cooperated with hundreds of medical device companies, including domestic and foreign listed companies and group companies, and assisted companies to obtain a large number of Class II and Class III medical device registration certificates, covering neurological intervention, cardiovascular intervention, non-vascular intervention, drainage, vascular spoon implantation, extracorporeal life support and other fields. Coating equipment and high-capacity coating production lines are sold at home and abroad. Jiangsu Baisaifei Biotechnology Co., Ltd. is the leading domestic technical service platform for the entire industry chain of medical functional coatings, and is a leading enterprise and leader in the field of medical coatings. Based on the founder's more than 20 years of professional accumulation in the field of biomaterial surface interfaces and academic influence at home and abroad, it focuses on innovative research and development of biomaterial surface modification technology, and develops high-end functional coatings and related products with independent intellectual property rights and international competitiveness. Since its establishment, the company has gone through several expansions and four rounds of financing, and now has more than 30,000m of R&D and production space. It has cooperated with hundreds of medical device companies, including domestic and foreign listed companies and group companies, and assisted companies to obtain a large number of Class II and Class III medical device registration certificates, covering neurological intervention, cardiovascular intervention, non-vascular intervention, drainage, intravascular implantation, extracorporeal life support and other fields. Coating equipment and high-capacity coating production lines are sold at home and abroad.
Coating categories include hydrophilic lubricating coatings, anticoagulant coatings, hydrophilic lubricating antibacterial coatings, hydrophobic coatings, anti-crystallization coatings, anti-fouling coatings, drug-releasing coatings, etc. The cooperation model includes coating liquid sales, coating equipment and coating testing instrument sales, coating ODM, coating inspection and testing, and coating customized R&D services.
According to public data from the State Intellectual Property Office, Baisaifei has become the company with the most applications and authorized patents in China in the global medical coating industry. It has also participated in a number of regulatory scientific research and the establishment of inspection and testing standards related to coated medical devices. It has formed a biomaterial surface modification technology as the core, integrating the research and development and production of coating materials, A comprehensive technical service and innovative product platform integrating advanced manufacturing of coating equipment, coating process development and customization, coating quality analysis instrument development and inspection and testing services, and research and development of new coated products, to create an internationally leading brand of independent and controllable biological functional coatings and related products, and promote the high-quality development of the health industry.
