rongsheng biotechnology made in china

The Center of Industrial Biotechnology (CIBT) was established in Huzhou for fine chemicals in 2006 and CIBT Shanghai was founded for bulk chemicals in 2008. CIBT is a non-profit organization under auspices of the Shanghai Institutes for Biological Sciences, Shanghai Branch of the Chinese Academy of Sciences (CAS) and Huzhou Municipal Government. CIBT is affiliated with the CAS, which enables it to take advantage of the rich R&D resources and support from CAS; yet CIBT operates as an independent legal entity. The goal of CIBT is to incubate industrial biotechnologies and accelerate the commercialization of these technologies with corporate partners in China.

Any equipment related to the production of medicine,ranging from major machines to a screw,has a decisive influence upon thequality of medicine.Rongsheng selected the first-grade production equipments and made strict operation and maintenance plans.

In order to guarantee the product quality from the origin,Rongsheng implements montoring to the material choosing,analysis thesample according to the standard and guarantee the safety and stability of production quality.Rongsheng has long-term and stablequality control capacity

characteristics of the products and its own managerial experience,Rongsheng made a set of quality management regulation with itsown features,the regulation was specified into standard operational procedures for each department and worker to abide by foreach step.At the same time.Rongsheng conducts"Products Quality Trend Analysis"through a series of methods such as qualitytest data and quality review.

Rongsheng is equipped with the most advanced test equipments,which can significantly enhance the rationality and accuracy oftest.Meanwhile,employees of test department must also abide by the standard operational procedures made for them,thus toexamine,monitor and verify the production environment,raw materials and products in different phases,and to conduct data

As for the requirements for employees,Rongsheng asks all of them to be technically skilled and pass GMP training.By doing so,the employees understand the importance of standard operational procedures and put them into daily work and form normativehabit.Rongsheng strengthens the training and guidance for employees to intensify the consciousness that"quality is life".

Keyword: Abstract: Objective To evaluate the feasibility of homemade reagents on Roche MODULAR P-800 automatic biochemical analyzer (P-800). Methods The homemade reagents [made in China,the regents of alanine aminotransferase (ALT),aspartate aminotransferase (AST),γ-glutamyltransferase(GGT),alkaline phosphatase(ALP),triglyeride(TG)and total cholesterol(TG) form Shanghai Rongsheng Biotechnology Co.Ltd;the reagents of total protein(TP),albumin(Alb)and urea from Shanghai Fuson Long March Medical Science Co.Ltd] and Roche original reagents were applied on P-800. Technology principle,analysis type,component and dosage form of regent of two regents was identical.The fresh mixed serum was determined by Roche reagent, and used as temporary calibrator. The homemade reagent was calibrated by the temporary calibrator. The value of cafs calibrator was available from the calibrated homemade reagent and the cafs calibrator composed determination system with calibrated homemade reagent. The precision, linearity and bias of homemade reagent were determined. The correlation analysis of two reagents was evaluated. The interference tests of two reagents were done. Results No matter how to test the low or high level samples, the intra-assay and inter-assay coefficient of variation(CV)of homemade reagent were<5%. 40 clinical samples were detemined by two reagents. The results were similar (P>0.05) and the correlation coefficient (r) was>0.975. The bias at medical decision level was lower than permissible error range. Two regents′ antiinterference abilities had no significant difference(r>0.975, P>0.05). Conclusions Compared with Roche original reagent, homemade reagent has good correlation, little bias, high precision and wide linearity. Homemade reagents have good antiinterference ability for lipemia and icterus samples. The results can be compared and are traceable. Homemade reagent can be alternative to Roche original reagent.