Comparison of the diphtheria toxin separation methods on standard vaccine strain using separator and filter presses to improve the quality & quantity of the final product

Document Type : Original Article


1 Department of Human Vaccines Research & Production, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj, Iran

2 Department of Human Vaccines Research & Production, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj, Iran

3 Microbiology Dept, Science faculty, Zanjan Azad University

4 Microbiology Dept, Pasteur Institute of Iran, Tehran


The aim of this research was based on increasing of the quantity, quality and effectiveness of this vaccine, protection of personnel and cost-benefit of production. In this regard two diphtheria toxin separation methods (Separator and Filter press) compared.
Corynebacterium diphtheria (PW-8/CN-2000) was cultivated in 350L fermentor and half of the cultivation toxin clarified by Seitz filter press method and diatomea earth as filter aid and the rest was clarified by separator. Three sterile samples (50 mL) of each three produced batches were assessed by minimum lethal dose (MLD), specific toxicity test (STT), toxin flocculation titer (Lf, Kf – Ramon flocculation test) and SDS–PAGE. Other parameters like time consumption for toxin clarification with specific volume, quantity, product clarification, volume and clarification of product in two methods compared.
The results confirmed that the separator clarification method was more advantageous to filter press. Also, volume and transparency of the final product after clarification by separator were better than Filterpress method. In addition, the separation time and costs used in the separator method were much less than Filterpress's method.
In conclusion, use of separator clarification method was suitable alternative to current filter press method in terms of quantity and quality of diphtheria vaccine production.


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