BIO-PHARMACEUTICALS and m RNA VACCINE: WHITE PAPER. PRODUCTION -QUALITY CONTROL: REGULATORY AND TOXICOLOGICAL ASPECT

      Аннотация: Observing the fact that every year various registerd and authorized drugs are recalled by the public regulatory agency (in example last Ranitidin cases due by the possibility of impurity presence of a cancerogenic sustantia) it is interesting to observe the innovative production strategy of some m RNA vaccine.Also for the bio-technological drugs product the regulatory agency ask quality stantard for impurity for the obiously safety implications.The biotechnological drugs, as the classic chemical drugs, due by the complex manifacturing process use raw material and industrial procedure that require Great quality monitoring according the GMP normative rules.So it is no to strange to discuss of impurities in this new kind of products.And also for the covid-19 vaccine.

Ключевые слова: graphene, Quality control, Toxicology, Regulatory Aspects, pathology