Changes And Validation Of The Analytical Method Of The Host Cell Protein In Recombinant Human Growth Hormone

With the development of modern biotechnology, more and more recombinant bioproducts are being sold in the market. Host Cell Protein is one of the important factors that affect the safety of the products, using repeatedly recombinant products with a certain amount of host protein might bring hypersusceptibility to the organisms. For the safety of using recombinant product, the amount of host cell protein must be strictly controlled.The measuring method of the host cell protein is ELISA. Through experimental validation, the limit of detection is 15ng/ml and 1.5ng. The limit of quantitation is 22ng/ml . This method has a good linearity. The value of r2 is bigger than 0.990. The range is 242-22ng/ml . The method has a good accuracy and the recovery is between 80% and 120%. This method has a good precision.