The Application and Critical Control Point of Formaldehyde During the Manufacturing of Vaccine Products

SAI Wen-bo, GUO Sheng-nan, GUO Shu-yang

Anhui Journal of Preventive Medicine ›› 2021, Vol. 27 ›› Issue (6) : 483-486.

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Anhui Journal of Preventive Medicine ›› 2021, Vol. 27 ›› Issue (6) : 483-486. DOI: 10.19837/j.cnki.ahyf.2021.06.016

The Application and Critical Control Point of Formaldehyde During the Manufacturing of Vaccine Products

  • SAI Wen-bo, GUO Sheng-nan, GUO Shu-yang
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Abstract

As a commonly used detoxifying agent or inactivating agent,formaldehyde can form a stable and irreversible connection with the amino or sulfhydryl group of protein,and then lead to protein inactivation,so it is widely used in the manufacturing process of various vaccine products,such as toxoid vaccine and virus inactivated vaccine.On the other hand,the tragedies caused by incomplete virus inactivation in history also remind researchers to pay full attention to the safety and effectiveness of formaldehyde in the manufacturing process.This paper summarizes the current use of formaldehyde in the manufacturing process of vaccine products from three aspects: formaldehyde application examples,manufacturing process and safety control points,and the limitations of the use of formaldehyde,in order to provide some reference for the development of this kind of products.

Key words

Formaldehyde / Vaccine Product / Manufacturing Process / Safety Control / Limitations

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SAI Wen-bo, GUO Sheng-nan, GUO Shu-yang. The Application and Critical Control Point of Formaldehyde During the Manufacturing of Vaccine Products[J]. Anhui Journal of Preventive Medicine. 2021, 27(6): 483-486 https://doi.org/10.19837/j.cnki.ahyf.2021.06.016

References

[1] OFFIT P A.The Cutter incident,50 years later[J].N Engl J Med,2005,352(14): 1411-1412.
[2] DELRUE I,VERZELE D,MADDER A,et al.Inactivated virus vaccines from chemistry to prophylaxis: merits,risks and challenges[J].Expert Rev.Vaccines,2012,11(6): 695-719.
[3] SUTHERLAND B W,TOEWS J,KAST J.Utility of formaldehyde cross-linking and mass spectrometry in the study of protein-protein interactions[J].J.Mass Spectrom.,2008,43(6): 699-715.
[4] METZ B,KERSTEN G F,HOOGERHOUT P,et al.Identification of formaldehyde-induced modifications in proteins: reactions with model peptides[J].J.Biol.Chem,2004,279(8): 6235-6243.
[5] YUEN C T,ASOKANATHAN C,COOK S,et al.Effect of different detoxification procedures on the residual pertussis toxin activities in vaccines[J].Vaccine,2016,34(18): 2129-2134.
[6] MARKEY K,ASOKANATHAN C,FEAVERS I.Assays for Determining Pertussis Toxin Activity in Acellular Pertussis Vaccines[J].Toxins (Basel),2019,11(7).
[7] 郭舒杨,姚昕,罗建辉.百日咳毒素脱毒的研究进展[J].中华微生物学和免疫学杂志,2018,038(010): 796-800.
[8] GHADERI S,BOZORGMEHR M R,AHMADI M,et al.Identification of Conformational B-cell Epitopes in Diphtheria Toxin at Varying Temperatures Using Molecular Dynamics Simulations[J].Arch Razi Inst,2021,75(4): 427-437.
[9] ALSARRAF H,DEDIC E,BJERRUM M J,et al.Biophysical comparison of diphtheria and tetanus toxins with the formaldehyde-detoxified toxoids,the main components of diphtheria and tetanus vaccines[J].Virulence,2017,8(8): 1880-1889.
[10] METZ B,MICHIELS T,UITTENBOGAARD J,et al.Identification of Formaldehyde-Induced Modifications in Diphtheria Toxin[J].J Pharm Sci,2020,109(1): 543-557.
[11] EMSLEY P,FOTINOU C,BLACK I,et al.The structures of the H(C) fragment of tetanus toxin with carbohydrate subunit complexes provide insight into ganglioside binding[J].J.Biol.Chem.,2000,275(12): 8889-8894.
[12] GUO J,PAN X,ZHAO Y,et al.Engineering Clostridia Neurotoxins with elevated catalytic activity[J].Toxicon,2013,74: 158-166.
[13] BAYART C,PERONIN S,JEAN E,et al.The combined use of analytical tools for exploring tetanus toxin and tetanus toxoid structures[J].J Chromatogr B Analyt Technol Biomed Life Sci,2017,1054: 80-92.
[14] XU X,CHEN P,WANG J,et al.Evolution of the novel coronavirus from the ongoing Wuhan outbreak and modeling of its spike protein for risk of human transmission[J].Sci.China Life Sci.,2020,63(3): 457-460.
[15] CHEN H,XIE Z,LONG R,et al.Immunological evaluation of an inactivated SARS-CoV-2 vaccine in rhesus macaques[J].Mol Ther Methods Clin Dev,2021.
[16] KIM E H,HAN G Y,NGUYEN H.An Adenovirus-Vectored Influenza Vaccine Induces Durable Cross-Protective Hemagglutinin Stalk Antibody Responses in Mice[J].Viruses,2017,9(8).
[17] BUDIMIR N,HUCKRIEDE A,MEIJERHOF T,et al.Induction of heterosubtypic cross-protection against influenza by a whole inactivated virus vaccine: the role of viral membrane fusion activity[J].PLoS One,2012,7(1): e30898.
[18] PERMANA P A,SNAPKA R M.Aldehyde-induced protein-DNA crosslinks disrupt specific stages of SV40 DNA replication[J].Carcinogenesis,1994,15(5): 1031-1036.
[19] NOLL D M,MASON T M,MILLER P S.Formation and repair of interstrand cross-links in DNA[J].Chem.Rev.,2006,106(2): 277-301.
[20] FELDMAN M Y.Reactions of nucleic acids and nucleoproteins with formaldehyde[J].Prog Nucleic Acid Res Mol Biol,1973,13: 1-49.
[21] HOWAT W J,WILSON B A.Tissue fixation and the effect of molecular fixatives on downstream staining procedures[J].Methods,2014,70(1): 12-19.
[22] 国家药典委员会.中华人民共和国药典[M].中国医药科技出版社,2020.
[23] CROPLEY I,DOUCE G,ROBERTS M,et al.Mucosal and systemic immunogenicity of a recombinant,non-ADP-ribosylating pertussis toxin: effects of formaldehyde treatment[J].Vaccine,1995,13(17): 1643-1648.
[24] 姜立民,林晓波,高磊,等.β-丙内酯对狂犬病病毒的灭活效果[J].国际流行病学传染病学杂志,2014,41(2): 137-139.
[25] 李华,岳磊,张也,等.不同灭活剂对柯萨奇病毒A组16型免疫原性的影响[J].中国生物制品学杂志,2020,33(11): 1217-1222.
[26] 张标,佟琳,易山,等 甲醛和β-丙内酯灭活轮状病毒的效果[J].四川医学,2013,34(7): 896-897.
[27] ZHAO F,LIU L,XU M,et al.Assessments of different inactivating reagents in formulating transmissible gastroenteritis virus vaccine[J].Virol.J.,2020,17(1): 163.
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