Fractional Factorial Analysis Of Immunoglobulin G Anti-Diphtheria Serum Fragmentation By Pepsin

The number of diphtheria outbreaks was observed to be quite high in the last 5 years. One way to treat diphtheria at the time of an outbreak is to use an anti-diphtheria serum. The availability of anti-diphtheria serum products worldwide has been reduced for years because manufacturers in several countries have stopped producing. The cessation of production is partly due to a decrease in demand, production failures and regulatory requirements in the manufacture of increasingly stringent biological products from the blood. In addition, the use of certain types of pepsin as a component of production becomes problematic with the issuance of Law No. 34 of 2014 concerning Guarantees of Halal Products. This study aims to analyze the use of pepsin A as a substitute for pepsin B, get parameters that have a significant effect on IgG fragmentation using fractional factorial design, get the optimum parameter value of IgG fragmentation (highest titer value, shortest Kf time and absence of IgG bands in SDS PAGE ) and increase anti-diphtheria serum product antibody titers. Risk analysis was carried out to find out several factors that influence the process of pepsin A fragmentation against IgG anti-diphtheria serum products using fishbone and FMEA methods. Factors belonging to the unacceptable and intolerable classification are purification methods (RPN 60 value), pH termination of the fragmentation process (RPN 100 value), fragmentation temperature (RPN 60 value), number of pepsin (RPN 12