Characterization of production processes for tetanus and diphtheria anatoxins |
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| Affiliation: | 1. Divisão de Desenvolvimento Tecnológico e Produção, Instituto Butantan, Av. Dr. Vital Brasil, 1500 São Paulo, Brazil;2. Laboratório de Bacteriologia, Instituto Butantan, Av. Dr. Vital Brasil, 1500 São Paulo, Brazil;1. Shimadzu Scientific Instrument Company, Beijing, 100010, China;2. National Institutes for Food and Drug Control, Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Beijing, 102629, China;3. Shimadzu (Asia Pacific) Pte Ltd, 118264, Singapore;4. Key Lab of Separation Science for Analytical Chemistry, Dalian Institute of Chemical Physics, Chinese Academy of Sciences, Dalian, 116023, China;1. Vaccine Bioprocess Research and Development, Merck Research Laboratories, Merck & Co., Inc., West Point, Pennsylvania 19486;2. Merck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey 07033;3. Infectious Diseases and Vaccines Discovery, Merck Research Laboratories, Merck & Co., Inc., West Point, Pennsylvania 19486;1. Laboratório de Bioprocessos, Centro de Biotecnologia, Instituto Butantan, Brazil;2. Laboratório Especial Piloto de Produtos Biológicos Recombinantes, Instituto Butantan, Brazil;3. Divisão de Desenvolvimento Tecnológico e Produção, Instituto Butantan, Brazil;1. The Advanced Centre for Biochemical Engineering, Department of Biochemical Engineering, University College London, Torrington Place, London, WC1E 7JE, UK;2. Purification Process Development, Pfizer, 1 Burtt Road, Andover, MA 01810, USA |
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| Abstract: | Tetanus and diphtheria are diseases that still cause significant morbidity and mortality. Clostridium tetani produces the tetanus toxin, a 150-kDa protein. The diphtheria toxin is synthesized by Corynebacterium diphtheriae as a protein of 58 kDa. The objective of this study was to carry out a chemical characterization of the tetanus and diphtheria toxin forms in the several production process stages, and thus to establish an affordable alternative in vitro quality control to aggregate to the classical tests. The 150 kDa band of the tetanus toxin and approximately 58 kDa band of the diphtheria toxin were observed by electrophoresis similar as that described in the literature. The same band of 58 KDa was detected in Western blotting reactions. The results obtained for diphtheria toxin showed very similar protein profiles between distinct lots. For the tetanus toxin, the profiles of the initial stage showed some variability, but the ones of the following stages were similar. The similarity of the electrophoresis results indicated reproduction and consistency of the production processes in Butantan Institute and correlated with the yield and antigenic purity classical data. The establishment of alternative in vitro quality control tests can significantly contribute to achieve the consistency approach supported by WHO. |
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| Keywords: | Tetanus toxin Diphtheria toxin Vaccine production |
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