Set Up And Validation Of The Determining Method Of The Host Cell Protein In Recombinant Human Growth Hormone

With the development of modern biotechnology, more and morerecombinant bioproducts are being sold in the market, Host Cell Protein isone of the important factors that affect the safety of the products, andrepeated using of recombinant products of host protein of a certain amountmay cause hypersusceptibility to the organisms. High sensitivity and goodrepetition measuring methods to the host cell protein should be set up.During the experiment, fist we prepared a patch of endo-control products asthe standard, and the semi-quantitive-measuring method of blot measuringhost cell protein method is got rid. Through comparison and selection of theexperiments in direct Elisa and double antibody Sandwich Elisa, doubleantibody Sandwich method that is more suitable is determined as the methodto measure Host cell proten in the recombinant Human Growth Hormone,also the methodology validation has been done to this measuring method,and it accords with the standard of Chinese Codex.Through experiments validation, this method has a good linearity.Whenlinearity regression of Y=ax+b is done, the value of r2 , which is bigger than0.994, is high. The measuring limitation is low which is only 1 ng, andquantitive measuring can be processec in the range of 10ng-320ng. Duringthe experiment of precision, it has a high accuracy, and the result is close to...