اخبار و اعلانات

 آمار

تعداد نشریات287
تعداد نشریات سازمان85
تعداد شماره‌ها3,159
تعداد مقالات35,108
تعداد مشاهده مقاله50,530,156
تعداد دریافت فایل اصل مقاله90,478,670
Soleimani, S. (1401). A Review of the Establishment of the Seed Lot System in the Production of Biological Products and Its Importance. سامانه مدیریت نشریات علمی, 77(6), 2023-2035. doi: 10.22092/ari.2022.358890.2327
S Soleimani. "A Review of the Establishment of the Seed Lot System in the Production of Biological Products and Its Importance". سامانه مدیریت نشریات علمی, 77, 6, 1401, 2023-2035. doi: 10.22092/ari.2022.358890.2327
Soleimani, S. (1401). 'A Review of the Establishment of the Seed Lot System in the Production of Biological Products and Its Importance', سامانه مدیریت نشریات علمی, 77(6), pp. 2023-2035. doi: 10.22092/ari.2022.358890.2327
Soleimani, S. A Review of the Establishment of the Seed Lot System in the Production of Biological Products and Its Importance. سامانه مدیریت نشریات علمی, 1401; 77(6): 2023-2035. doi: 10.22092/ari.2022.358890.2327

A Review of the Establishment of the Seed Lot System in the Production of Biological Products and Its Importance

Archives of Razi Institute
مقاله 3، دوره 77، شماره 6، بهمن و اسفند 2022، صفحه 2023-2035    اصل مقاله (408.66 K)
نوع مقاله: Review Article
شناسه دیجیتال (DOI): 10.22092/ari.2022.358890.2327
نویسنده
S Soleimani*
Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), P.O. Box 31975-148, Karaj, Iran
چکیده
Today, due to the importance of diseases controlled by vaccination, the production of biological products is of great importance in ensuring public health, so producing high-quality biological products plays an important role in maintaining public health. One of the most important principles of manufacturing high-quality and efficient biological products is using suitable seeds based on standard principles. To produce a suitable seed for continuous use for mass production of biological products, the seed must be defined according to certain principles and foundations. These principles are formed in the form of a seed lot system. In this review article, all the requirements for the establishment of a seed to produce a biological product include general seed information, including basic and seed information and microorganisms, seed-specific information including seed passage levels, propagation method, seed storage conditions, coding and labeling, identification information and design of suitable laboratories for passage, seed propagation, and storage, determination of seed characteristics including all necessary tests to determine seed identity, purity, potency, efficacy, stability, safety and also all the necessary information for documenting and storing seeds has been studied. Also, this study discusses the method of preparing all the necessary information for establishing a seed lot system, especially determining the characteristics of seeds. Based on the study's results, a complete and comprehensive seed lot system has been formed that can be used to prepare, propagate, passage, and store seeds used in the production of biological products.
کلیدواژه‌ها
Vaccine؛ Seed؛ Lot؛ System؛ Characterization
عنوان مقاله [English]
مروری بر نحوه استقرار سامانه بذر در تولید فراورده های بیولوژیک و مطالعه اهمیت آن
چکیده [English]
امروزه با توجه به اهمیت بیماری های قابل کنترل با واکسیناسیون، صنعت تولید فراورده های بیولوژیک از اهمیت به سزایی در تامین سلامت جامعه دارد، به طوریکه تولید فراورده های بیولوژیک با کیفیت بالا در حفظ سلامت جامعه نقش به سزایی دارد. از مهمترین مبانی تولید فراورده های بیولوژیک با کیفیت بالا و مناسب، استفاده از بذر مناسب و بر اساس اصول استاندارد می باشد. برای ایجاد یک بذر مناسب جهت استفاده مداوم برای تولید انبوه فراورده های بیولوژیک، باید بذر بر اساس اصول و مبانی خاصی تعریف شده باشد. این اصول در قالب سیستمی به نام سامانه بذر شکل می گیرد.
در این مقاله مروری، کلیه موارد مورد نیاز برای قرار گرفتن یک بذر برای تولید یک فراورده بیولوژیک شامل، اطلاعات عمومی بذر شامل اطلاعات اولیه و اطلاعات بذرشناسی و میکروارگانیسمی، اطلاعات اختصاصی بذر شامل سطوح پاساژ بذر، نحوه تکثیر، شرایط ذخیره سازی بذر، کدگذاری و لیبل گذاری، اطلاعات شناخت و طراحی آزمایشگاه های مناسب برای پاساژ، تکثیر و نگهداری بذر، تعیین خصوصیات بذر شامل کلیه آزمایش های لازم برای تعیین هویت بذر، خلوص بذر، توانمندی بذر، اثر گذاری بذر، پایداری بذر، بی ضرری بذر و همچنین کلیه اطلاعات لازم برای مستندسازی و ذخیره سازی بذر، مورد مطالعه و بررسی قرار گرفته است.
همچنین در این مطالعه، روش تهیه کلیه اطلاعات لازم برای استقرار سامانه بذر به ویژه تعیین خصوصیات بذر، بحث شده است. بر اساس نتایج مطالعه انجام گرفته، یک سامانه بذر کامل و جامع شکل گرفته است که می تواند برای تهیه، تکثیر، پاساژ و نگهداری بذرهای مورد استفاده در تولید فراورده های بیولوژیک، مورد استفاده قرار گیرد.
کلیدواژه‌ها [English]
واکسن, بذر, سامانه, تعیین خصوصیات, آزمایش
سایر فایل های مرتبط با مقاله
مراجع
  1. Sheets R, Petricciani J. Vaccine Cell Substrates 2004. Expert Rev Vaccines. 2004;3(6):633-8.
  2. Horimoto T, Takada A, Fujii K, Goto H, Hatta M, Watanabe S, et al. The development and characterization of H5 influenza virus vaccines derived from a 2003 human isolate. Vaccine. 2006;24(17):3669-76.
  3. A. Trovero C, Arguelles, A, Cataldi. Preparation of a working seed lot of BCG and quality control by PCR genotyping. Rev Argent Microbiol. 2010;42:4-10.
  4. Shahkarami MK, Mokhtari Azad T, Aghaiypour K, Shafyi A, Taqavian M, Mohammadi A. Establishment of a standard seed lot system of an Iranian Mumps virus strain; RS-12, for mass production of mumps and MMR vaccines. Iran Red Crescent Med J. 2012;14(9):508-14.
  5. Alamian S, Dadar M, Behroozikhah am, soleimani s, Aetemady A. A case of identity confirmation of Brucella abortus S99 by phage typing and PCR methods. Arch Razi Inst. 2019;74(2):127-33.
  6. Chang J-Y, Chang C-P, Tsai HH-P, Lee C-D, Lian W-C, Ih Jen S, et al. Selection and characterization of vaccine strain for Enterovirus 71 vaccine development. Vaccine. 2012;30(4):703-11.
  7. Pfeiffer J, Pantin-Jackwood M, To TL, Nguyen T, Suarez DL. Phylogenetic and biological characterization of highly pathogenic H5N1 avian influenza viruses (Vietnam 2005) in chickens and ducks. Virus Res. 2009;142(1):108-20.
  8. Ebrahimi M, Shahsavandi S, Masoudi S, Ghodsian N. Isolation, Characterization and Standardization of New Infectious Bursal Disease Virus for Development of a Live Vaccine. Iran J Virol. 2013;7(4):29-36.
  9. Fatima AT NT, Ballal A, Elhussein AM and Abdelmahmoud Atta AE. Production of Camel Pox Vaccine in the Sudan. J Vet Sci Med Diagn 2017;6(4).
  10. del Puerto-Sardiñas CA H-FM, González-Rodríguez H, Leyva-Rodríguez AL, Baños-Paiffer N, Fernández-Esperón IM, Cruz-Ferrer A, Martínez-Rivera R. Seed Lot System from Neisseria meningitidis strains cultured in non-animal origin media. VacciMonitor. 2016;25(1):1-4.
  11. Paulo Roberto Post RdC, Marcos da Silva Freire, Ricardo Galler. The Early Use of Yellow Fever Virus Strain 17D for Vaccine Production in Brazil – A Review. Mem Inst Oswaldo Cruz, Rio de Janeiro. 2001;96(6):849-57.
  12. Nicola M T, Sheldon L, Spector, Ruth L, Kirschstein, Edward B, Seligmann, JR, and Jane Farber. Yellow Fever Vaccine, Antigenicity and Neurovirulence of a Vaccine Seed Free from Avian Leukosis Virus. Appl Microbiol. 1969;17(6):866-70.
  13. Bordaşiu R, Drăghici D, Olinescu E, Piţur I, Bâca L, Balazs D, et al. Preparation of the B.C.G. vaccine in seed-lot system avoiding inoculation on Sauton-potato. Archives roumaines de pathologie experimentales et de microbiologie. 1976;35(1-2):102-9.
  14. Xue J, Chambers BS, Hensley SE, López CB. Propagation and Characterization of Influenza Virus Stocks That Lack High Levels of Defective Viral Genomes and Hemagglutinin Mutations. Front Microbiol. 2016;7.
  15. Le LT, Nguyen TV, Nguyen PM, Huong NT, Huong NT, Huong NTM, et al. Development and characterization of candidate rotavirus vaccine strains derived from children with diarrhoea in Vietnam. Vaccine. 2009;27:F130-F8.
  16. Tangy F. Yellow Fever Vaccine Attenuation Revealed: Loss of Diversity. J Infect Dis. 2014;209(13):318-20.
  17. Kim T, Huynh LT, Hirose S, Igarashi M, Hiono T, Isoda N, et al. Characteristics of Classical Swine Fever Virus Variants Derived from Live Attenuated GPE− Vaccine Seed. Viruses. 2021;13(8):1672.
  18. Eggert D, Thomas C, Spackman E, Pritchard N, Rojo F, Bublot M, et al. Characterization and efficacy determination of commercially available Central American H5N2 avian influenza vaccines for poultry. Vaccine. 2010;28(29):4609-15.
  19. Sanders BP, Edo-Matas D, Papic N, Schuitemaker H, Custers JHHV. Synthetic virus seeds for improved vaccine safety: Genetic reconstruction of poliovirus seeds for a PER.C6® cell based inactivated poliovirus vaccine. Vaccine. 2015;33(42):5498-502.
  20. Shcherbik S, Pearce N, Balish A, Jones J, Thor S, Davis CT, et al. Generation and Characterization of Live Attenuated Influenza A(H7N9) Candidate Vaccine Virus Based on Russian Donor of Attenuation. Plos One. 2015;10(9):e0138951.
  21. Abbas AM, Abd El-Moaty DAM, Zaki ESA, El-Sergany EF, El-Sebay NA, Fadl HA, et al. Use of molecular biology tools for rapid identification and characterization of Pasteurella spp. Vet World. 2018;11(7):1006-14.
  22. Weeks-levy C, Tatem JM, Dimichele SJ, Waterfield W, Georgiu AF, Mento SJ. Identification and characterization of a new base substitution in the vaccine strain of sabin 3 poliovirus. Virology. 1991;185(2):934-7.
  23. White KM, Ayllon J, Mena I, Potenski A, Krammer F, García-Sastre A. Influenza B virus reverse genetic backbones with improved growth properties in the EB66® cell line as basis for vaccine seed virus generation. Vaccine. 2018;36(9):1146-53.
  24. Marchevsky RS, da Luz Leal M, Homma A, Coutinho ESF, Camacho LAB, Jabor AV, et al. Molecular and phenotypic analysis of a working seed lot of yellow fever virus 17DD vaccine strain produced from the secondary seed lot 102/84 with an additional passage in chicken embryos. Biologicals. 2006;34(3):191-7.
  25. Patel EH, Lubembe DM, Gachanja J, Mwaura S, Spooner P, Toye P. Molecular characterization of live Theileria parva sporozoite vaccine stabilates reveals extensive genotypic diversity. Vet Parasitol. 2011;179(1):62-8.
  26. Wang L, Wang L, Zhuang H. Profiling and characterization of SARS-CoV-2 mutants’ infectivity and antigenicity. Signal Transduct Target Ther. 2020;5(1):185.
  27. Feshchenko E, Rhodes DG, Felberbaum R, McPherson C, Rininger JA, Post P, et al. Pandemic influenza vaccine: characterization of A/California/07/2009 (H1N1) recombinant hemagglutinin protein and insights into H1N1 antigen stability. BMC Biotechnol. 2012;12(1):77.
  28. Stefan Panaiotov YH,  VT,  BT,  AM, Stefanova aT. Complete Genome Sequence, Genome Stability and Phylogeny of the Vaccine Strain Mycobacterium bovis BCG SL222 Sofia. Vaccines. 2021;9(237):1-10.
  29. Wada T, Maruyama F, Iwamoto T, Maeda S, Yamamoto T, Nakagawa I, et al. Deep sequencing analysis of the heterogeneity of seed and commercial lots of the bacillus Calmette-Guérin (BCG) tuberculosis vaccine substrain Tokyo-172. Sci Rep. 2015;5(1):17827.
  30. Narvskaya O, Starkova D, Levi D, Alexandrova N, Molchanov V, Chernyaeva E, et al. First insight into the whole-genome sequence variations in Mycobacterium bovis BCG-1 (Russia) vaccine seed lots and their progeny clinical isolates from children with BCG-induced adverse events. BMC Genom. 2020;21(1):567.
  31. Huang CY-H KR, Livengood JA, Bolling B, Arguello JJ, Luy BE, et al. Genetic and Phenotypic Characterization of Manufacturing Seeds for a Tetravalent Dengue Vaccine (DENVax). PLoS Negl Trop Dis 2013;7(5):e2243.
  32. Soleimani S. Stability Study of Measles AIK-C Strain, Mumps RS-12 Strain and Rubella Takahashi Strain in MMR Vaccine. Arch Razi Inst. 2016;71(1):21-8.
  33. Soleimani S, Bordbar N. Stability Study of Razi Trivalent and Monovalent Oral Poliomyelitis Vaccine %J Arch Razi Inst. 2012;67(1):27-34.
  34. Soleimani S, Kamalzadeh M, Lotfi M. Preparation and Characterization of a Neutralizing Monoclonal Antibody against Poliovirus Type 1 (Mahoney Strain). Med Lab J. 2019;13(1):6-11.
  35. Ziyaeifar F, Soleimani S, Lotfi M. Identification of Iranian BHK-21-C5 Cell Line by Two Steps Polymerase Chain Reaction. Arch Razi Inst. 2021;76(2):193-201.
  36. Soleimani S, Lotfi M, Taghavian M, shahkarami mk. Evaluation of adventitious agents in mmr & oral poliomyelitis vaccines. Iran J Virol. 2011;5(1).
  37. Nagarajan T, Rupprecht CE. History of Rabies and Rabies Vaccines. In: Ertl HCJ, editor. Rabies and Rabies Vaccines. Cham: Springer International Publishing; 2020. p. 11-43.
  38. Murphy FA, Osburn BI. Adventitious agents and smallpox vaccine in strategic national stockpile. Emerg Infect Dis. 2005;11(7):1086-9.
  39. Singh P, Kim T-J, Tripathy DN. Identification and Characterization of Fowlpox Virus Strains Using Monoclonal Antibodies. J Vet Diagn Invest. 2003;15(1):50-4.
  40. Fouchier RAM, Smith DJ. Use of Antigenic Cartography in Vaccine Seed Strain Selection. Avian Dis. 2010;54(s1):220-3.
  41. Shulman LM, Martin J, Sofer D, Burns CC, Manor Y, Hindiyeh M, et al. Genetic Analysis and Characterization of Wild Poliovirus Type 1 During Sustained Transmission in a Population With >95% Vaccine Coverage, Israel 2013. Clin Infect Dis. 2014;60(7):1057-64.
  42. Yehia N, Hassan WMM, Sedeek A, Elhusseiny MH. Genetic variability of avian influenza virus subtype H5N8 in Egypt in 2017 and 2018. Arch Virol. 2020;165(6):1357-66.
  43. Mikhael C, Ibrahim M, Awad M, Soliman S, Michael A. Comparative study on the efficiency of some Capripox vaccines in protection of cattle against Lumpy skin disease. Suez Canal Vet Med J. 2014;19(2):177-92.
  44. Frierson JG. The yellow fever vaccine: a history. The Yale journal of biology and medicine. Yale J Biol Med. 2010;83(2):77-85.
  45. Galler R, Pugachev KV, Santos CLS, Ocran SW, Jabor AV, Rodrigues SG, et al. Phenotypic and Molecular Analyses of Yellow Fever 17DD Vaccine Viruses Associated with Serious Adverse Events in Brazil. Virology. 2001;290(2):309-19.
  46. Pruchová J, Sír Z. Comparative assay of immunization potencies of the Czechoslovak, Danish and Japanese vaccines as a preliminary step to the seed lot system in the production of BCG vaccine in Czechoslovakia. Prog Immunobiol Stand. 1971;5:442-6.
  47. Germanier R, Fürer E. Characteristics of the attenuated oral vaccine strain "S. typhi" Ty 21a. Dev Biol Stand. 1983;53:3-7.
  48. Shibayama K, Mochida K, Yagi T, Mori S, Arakawa Y, Yamamoto S. Quantification of two variant strains contained in freeze-dried Japanese BCG vaccine preparation by real-time PCR. Biologicals. 2007;35(2):139-43.
  49. Serrão de Andrade AA, Soares AER, Paula de Almeida LG, Ciapina LP, Pestana CP, Aquino CL, et al. Testing the genomic stability of the Brazilian yellow fever vaccine strain using next-generation sequencing data. Interface Focus. 2021;11(4).
  50. Beale AJ. Production of Vaccines with Special Reference to Rubella Vaccine RA 27/3 Strain in WI 38 Cells. In: Kohn A, Klingberg MA, editors. Immunity in Viral and Rickettsial Diseases: Proceedings of the Seventeenth Annual “OHOLO” Biological Conference on New Concepts in Immunity in Viral and Rickettsial Diseases Held March 13–16, 1972, at Zichron Yaakov, Israel. Boston, MA: Springer US; 1972. p. 179-86.
آمار
تعداد مشاهده مقاله: 68,211
تعداد دریافت فایل اصل مقاله: 68,226


counter
سامانه مدیریت نشریات علمی. طراحی و پیاده سازی از سیناوب