Research progress and prospects of standardized testing and assessment for nanobiomaterials
Nanobiomaterials,as nanotechnology-derived biomaterials,are referred to those biomaterials whose structures or components exhibit novel and significantly changed properties when their dimensions are at the nanoscale(1-100 nm).Hence,due to the unique features,nanobiomaterials have been extensively applied to targeted drug delivery,medical imaging,tissue engineering,biosensing as well as cosmetics over the past few decades.Meanwhile,the new characteristics of nanobiomaterials can also bring potential risks in biological safety together with performance.Currently,China has played a large role in the development of nanoscience and nanotechnology in the world in quite a lot of benefits related fields since there are the most abundant nano-related publications.Additionally,since National Technical Committee 279 on Nanotechnology of Standardization Administration of China was founded in 2005,China has released more than 100 national standards in the field of nanobiomaterials and over 30 related national standard plans are under development.Moreover,the industry standards for medical devices containing nanomaterials in China have been vigorously pushed forward.In the past China tended to publish scientific papers for original research,but now analytic data have shown an exponential growth in the nanobiomaterials related patents,about more than 1700 cases.However,nanotechnology translation is far behind in our country.There are very few real nano-products in the biomedical field.As for the translation from nanobiomaterials to biomedical applications,there are still so many critical issues which need to be addressed urgently,mainly including quality control and biosafety evaluation.The major challenges consist in the accurate measurement of physicochemical properties for nanobiomaterials and the setup of nano-biosafety knowledge system.Although some advanced techniques can give a valuable understanding of nanobiomaterials,especially for some special scenarios involving the presence of nanobiomaterials in complex matrices to confirm nano-content labeling as well as nanobiomaterial release from medical devices and so on.The repeatability and applicability of these measurements based on advanced techniques are still limited so far,which can be improved by standardized testing.In addition,there is still a lack of standardized biological assays as well as experimental animal models for biosafety evaluation.Standardization is the bridge of innovation-driven development as an indispensable way to achieving the repeatability and reproducibility of new technologies and large-scale production.It can also push the marketization and internationalization of these new advanced technologies and be very helpful to promote China transformation from"Made in China"to"Chinese Standards".Therefore,the standardized testing will definitely provide much more accurate and reliable information regarding the characterization of physicochemical properties and risk-benefit evaluation of nanobiomaterials.In order to offer a strong support and reference for nanobiomaterial development and nanotechnology translation in our country,this review summarizes the current situation of standardized testing,existing issues and development trend of physicochemical characterization and biosafety evaluation for nanobiomaterials as well as the related products.As new strategic and cutting-edge materials around the world,the development and application of nanobiomaterials will be bound to further improve the overall medical efficiency and support the national strategy of healthy in China in the future.
NETL
NSTL
万方数据
维普
