Dissertation
Dissertation > Industrial Technology > Chemical Industry > Other chemical industries > Protein ( PrP ) and the chemical processing industry > Chemical processing > Various proteins

Process Optimization and Engineering Design of Intravenous Immunoglobulin G

Author ZhangFeng
Tutor ZuoHengChang
School Shandong University
Course Pharmaceutical Engineering
Keywords Raw plasma Immunogloblin G Product yield Engineering design
CLC TQ936.2
Type Master's thesis
Year 2013
Downloads 106
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Human immunoglobulin(Immunoglobulin, Ig), also called antibodies, is the main material of human immune response to foreign antigen, such as bacteria, viruses and other toxins or foreign matter. The products of human immunoglobulin come from plasma can be classified into intravenous immunoglobulin G (IVIG) and intramuscular immunoglobulin(IMIG)according to injection route. The main component of the products is immunoglobulin G, which is one of the important components of plasma protein. The molecular weight and the sugar content of immunoglobulin G is150kDaand2~3%, separately. The concentrationof immunoglobulin G is6.6~14.5g/L, which is about75%of the total serum immunoglobulin in the plasma.The price of human immunoglobulin is very expensive for the shortage of human plasma, but the demand of the market is still huge. At the same time, the demand in domestic and international and clinical indicationsof IVIG is increasing, therefore, the price of IVIG will continue to increase in the futureand the market prospect is broad. Therefore, makingfull use of the existing resources of human plasma and improvingthe yield and quality of IVIGwill have great practical and social significance in expanding market supply and alleviating the domestic human immunoglobulin for intravenous injection of the tight supply. What’s more, it also has important significance for promoting the development of human medicine.At present, the blood products manufacturer for IVIG (pH4) in the preparation process adopt the traditional way of cold ethanol. Although the process is the same, but the yield is large difference. Shandong Taibang Biological Products company is dedicated to the study of the whole process, which can improve the product yield and product quality, in order to improve the comprehensive utilization rate of plasma.This study is based on the five variable factors in the preparation ofIVIG(pH4). By analysing the release and aggregation of IgG in the improvements of protein separation equipment and the steps of protein preparation process,wefound and optimized the main factors which could increase the yield of IgG. Then, the product yield of before and after process optimization were analyzed retrospectivelyto provethat the process optimization hasimproved the yield of IVIG. At the same time, product qualities are analyzed to ensure the quality index of the product is not affectedafter process optimization..Finally, designing of preparation plant, production equipment and facilities forIVIG (pH4) according to the experimental results in order to provide basis for the construction ofnew plant in company.

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