pmedpharmФармация и фармакологияPharmacy & Pharmacology2307-92662413-2241Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical Univer10.19163/2307-9266-2022-10-2-154-163pmedpharm-1069Research ArticleОБЗОРЫ, ЛЕКЦИИREVIEWS, LECTURESМИНИМИЗАЦИЯ РИСКОВ ПРИМЕНЕНИЯ ЛЕКАРСТВЕННЫХ ПРЕПАРАТОВ НА ОСНОВЕ ПЫЛЬЦЫ НА СТАДИИ ЗАГОТОВКИ СЫРЬЯMINIMISATION OF RISKS ASSOCIATED WITH THE USE OF POLLEN-BASED MEDICINES, AT THE STAGE OF POLLEN COLLECTIONhttps://orcid.org/0000-0001-5594-4859ТаубэА. А.TaubeA. A.

кандидат фармацевтических наук, ведущий научный сотрудник Центра планирования и координации научно-исследовательских работ ФГБУ НЦЭСМП Минздрава России

127051, Россия, Москва, Петровский б-р, д. 8, стр. 2 

Candidate of Sciences (Pharmacy), Leading Researcher at the Center for Planning and Coordination оf Research Works of the Scientific Centre for Expert Evaluation of Medicinal Products.

Bld. 2, 8, Petrovsky Blvd, Moscow, Russia, 127051

Aleksandra.taube@pharminnotech.comhttps://orcid.org/0000-0001-7033-424XБуяноваТ. А.BuyanovaT. A.

магистрант кафедры экономики и управления ФГБОУ ВО СПХФУ Минздрава России

197376, Россия, Санкт-Петербург, ул. Профессора Попова, д. 14, лит. А

Master’s student of the Department of Economics and Management of St. Petersburg Chemical and Pharmaceutical University.

Bld. A, 14, Prof. Popov Str., St. Petersburg, Russia, 197376

buyanovatanya1@gmail.comhttps://orcid.org/0000-0001-8536-4804СаканянЕ. И.SakanyanE. I.

доктор фармацевтических наук, директор по науке АО «НПО «Микроген»

115088, Россия, Москва, 1-я Дубовская ул., д. 15, стр. 2

Doctor of Sciences (Pharmacy), Director of Research, Joint-Stock Company “Scientific and Production Association “Microgen”

Bld. 2, 15, 1st Dubovskaya Str., Moscow, Russia, 115088

sakanjan@mail.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian FederationФедеральное государственное бюджетное образовательное учреждение высшего образования «Санкт-Петербургский химико-фармацевтический университет» Министерства здравоохранения Российской ФедерацииРоссияSt. Petersburg Chemical and Pharmaceutical UniversityRussian FederationАкционерное общество «Научно-производственное объединение «Микроген»РоссияJoint-Stock Company “Scientific and Production Association “Microgen”Russian Federation202203052022102154163Copyright © Таубэ А.А., Буянова Т.А., Саканян Е.И., 20222022Таубэ А.А., Буянова Т.А., Саканян Е.И.Taube A.A., Buyanova T.A., Sakanyan E.I.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmpharm.ru/jour/article/view/1069Цель

Цель. Подготовка проекта Правил заготовки (сбора) растительной пыльцы для минимизации рисков при применении лекарственных препаратов на основе пыльцы.

Материалы и методы

Материалы и методы. В исследовании использовали следующие электронные ресурсы: PubMed, Medline, ScienceDirect, Web of Science, Scopus, Google Scholar, eLibrary, World Allergy Organization, Cochrane Database, Stallergenesgreer, Allergenscienceandconsulting, Pharmacopoeia, Fda.gov, fs.usda.gov, Ema.europa.eu. Поиск осуществляли за период с 1 января 201 по 31 декабря 2021.

Результаты

Результаты. В настоящее время в России существуют общие требования к качеству пыльцевого материала, однако какой-либо контроль и стандартизация процесса заготовки, сушки и очистки отсутствует. В США и ЕС также отсутствуют установленные программы квалификации организаций по сбору пыльцы и/или индивидуальных сборщиков. Регуляторные органы ограничиваются визуальными требованиями к исходному сырью или возлагают ответственность на усмотрение производителя. В ходе анализа действующих нормативных документов было выявлено отсутствие требований в отношении сбора, хранения и обработки пыльцы, используемой в качестве сырья для производства лекарственных препаратов аллергенов. В связи с этим существует необходимость разработки нормативных документов. Составлены «Правила заготовки (сбора) пыльцы», в которых выделены 6 разделов. Правила предназначены для лиц, непосредственно осуществляющих заготовку (сбор) пыльцы, и содержат требования к заготовителям, к процессу сбора пыльцы, документации, хранению и транспортированию пыльцы.

Заключение

Заключение. Составлены «Правила заготовки (сбора) пыльцы», в которых выделены 6 разделов. Составленные Правила полностью регламентируют процесс сбора пыльцы и все сопутствующие ему процессы. Внедрение документа позволит повысить качество сбора пыльцы, тем самым уменьшить риски применения лекарственных препаратов на ее основе. Планируется изучение влияния качества пыльцевого сырья на безопасность применения лекарственных препаратов.

The aim of the study is the elaboration of Rules for Harvesting/Collecting of Pollen to minimize the risks associated with the use of pollen-based medicinal products.

Materials and methods

Materials and methods. The following electronic resources were used in the study: PubMed, Medline, ScienceDirect, Web of Science, Scopus, Google Scholar, eLibrary, World Allergy Organization, Cochrane Database, Stallergenesgreer, Allergenscienceandconsulting, Pharmacopoeia, Fda.gov, fs.usda.gov, Ema.europa.eu. The analysis covered the period from January 1, 2010 until December 31, 2021.

Results

Results. Currently, there are some general requirements for the quality of pollen in Russia, but there are no controls or standardised procedures for harvesting, drying, and purification of pollen. The USA and EU also lack established qualification programmes for pollen-collecting companies and/or individual pollen collectors. Regulatory authorities establish requirements only for visual control of raw materials or delegate responsibility to the manufacturer. The analysis of the existing regulatory documentation revealed lack of requirements for collection, storage, and processing of pollen used as the raw material for the production of allergen products. This calls for the elaboration of appropriate regulatory documents. The authors have compiled the Rules for Harvesting/Collection of Pollen, which include 6 parts. The Rules are intended for individuals directly involved in harvesting/collection of pollen, and contain requirements for pollen collectors, the process of pollen collection, documentation, storage, and transportation.

Conclusion

Conclusion. The authors have prepared the Rules for Harvesting/Collecting of Pollen, which include 6 parts. The Rules cover the whole process of pollen collection and all related processes. The implementation of this document will improve the process of pollen collection, thus reducing the risks associated with the use of pollen-based medicines. Further studies will assess the impact of the pollen quality on the safety of medicinal products.

аллергенспецифическая иммунотерапиялекарственное растительное сырьебезопасность применения лекарственных препаратовнадлежащая практика сборанежелательные реакциипыльцаэкстракт аллергенаallergen-specific immunotherapyherbal substancessafe use of medicinal productsgood collection practiceadverse drug reactionspollenallergen extractРабота выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00001-22-00 на проведение прикладных научных исследований (номер государственного учета НИР 121021800098-4).The study reported in this publication was carried out as a part of a publicly funded research project No. 056-00001-22-00 and was supported by the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation (R&D public accounting No. 121021800098-4).ReferencesBastl K., Bastl M., Bergmann K.C., Berger M., Berger U. Translating the Burden of Pollen Allergy Into Numbers Using Electronically Generated Symptom Data From the Patient’s Hayfever Diary in Austria and Germany: 10-Year Observational Study // J. Med. Internet. Res. – 2020. – Vol. 22, No.2. – Art. No.16767. DOI: 10.2196/16767.Bastl K, Bastl M, Bergmann K-C, Berger M, Berger U. Translating the Burden of Pollen Allergy Into Numbers Using Electronically Generated Symptom Data From the Patient’s Hayfever Diary in Austria and Germany: 10-Year Observational Study. J Med Internet Res. 2020; 22(2):e16767. DOI: 10.2196/16767.Kiguchi T., Yamamoto-Hanada K., Saito-Abe M., Sato M., Irahara M., Ogita H., Miyagi Y., Inuzuka Y., Toyokuni K., Nishimura K., Ishikawa F., Miyaji Y., Kabashima S., Fukuie T., Narita M., Ohya Y. Pollen-food allergy syndrome and component sensitization in adolescents: A Japanese population-based study // PLoS One. – 2021. – Vol. 16, No.4. – Art. No.0249649. DOI: 10.1371/journal.pone.0249649.Kiguchi T, Yamamoto-Hanada K, Saito-Abe M, Sato M, Irahara M, Ogita H, Miyagi Y, Inuzuka Y, Toyokuni K, Nishimura K, Ishikawa F, Miyaji Y, Kabashima S, Fukuie T, Narita M, Ohya Y. Pollen-food allergy syndrome and component sensitization in adolescents: A Japanese population-based study. PLoS One. 2021 Apr 14;16(4):e0249649. DOI: 10.1371/journal.pone.0249649.Ta V., Scott D.R., Chin W.K., Wineinger N.E., Kelso J.M., White A.A. Differential skin test reactivity to pollens in pollen food allergy syndrome versus allergic rhinitis // Allergy. Asthma. Proc.–2015. – Vol. 36, No.5. – P. 379–385. DOI: 10.2500/aap.2015.36.3862.Ta V, Scott DR, Chin WK, Wineinger NE, Kelso JM, White AA. Differential skin test reactivity to pollens in pollen food allergy syndrome versus allergic rhinitis. Allergy Asthma Proc. 2015;36(5):379–85. DOI: 10.2500/aap.2015.36.3862.Poncet P., Sénéchal H., Charpin D. Expert Update on pollen-food allergy syndrome // Rev. Clin. Immunol. – 2020. – Vol. 16, No.6. – P. 561–578. DOI: 10.1080/1744666X.2020.1774366.Poncet P, Sénéchal H, Charpin D. Expert Update on pollen-food allergy syndrome. Rev Clin Immunol. 2020;16(6):561–78. DOI: 10.1080/1744666X.Yagami A., Ebisawa M New findings, pathophysiology, and antigen analysis in pollen-food allergy syndrome // Curr. Opin. Allergy Clin. Immunol. – 2019. – Vol. 19, No.3. – P. 218–223. DOI: 10.1097/ACI.0000000000000533.1774366.Петрова С.Ю., Бержец В.М., Петрова Н.С., Хрулёва В.А., Емельянов О.Ю., Хлгатян С.В. Коренева Е.А. Перспективы развития лечебных форм аллергенов. От абстрактных проблем к конкретным решениям. // Иммунопатология, аллергология, инфектология. – 2018. – №1. – С. 40–47. DOI: 10.14427/jipai.2018.1.40.Yagami A, Ebisawa M. New findings, pathophysiology, and antigen analysis in pollen-food allergy syndrome. Curr Opin Allergy Clin Immunol. 2019;199(3):218-23. DOI: 10.1097/ACI.0000000000000533.Fortescue R., Kew K. M., Tsun Leung M.S. Sublingual immunotherapy for asthma // Cochrane Database Syst. Rev. – 2020. – Vol. 9, No.9. – CD011293. DOI: 10.1002/14651858.CD011293.pub3.Petrova SYu, Berzhets VM, Petrova NS, Hrulyova VA, Emel’yanov OYu, Hlgatyan SV, Koreneva EA. Perspektivy razvitiya lechebnyh form allergenov. Ot abstraktnyh problem k konkretnym resheniyam. [Immunopatologiya, allergologiya, infektologiya]. Journal of immunopatologiya, allergologiya, infektologiya. 2018;1:40–7. DOI: 10.14427/jipai.2018.1.40. RussianAsero R., Gianni Mistrello G., Amato S. Detection of pan-allergens in commercial pollen extracts for allergen immunotherapy // Ann. Allergy. Asthma. Immunol. – 2016. – Vol. 117, No.2. – P. 180–1855. DOI: 10.1016/j.anai.2016.05.010.Fortescue R, Kew KM, Tsun Leung MS. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020;9(9):CD011293. DOI: 10.1002/14651858.CD011293.pub3.Kleine-Tebbe J., Matricardi P.M., G Hamilton R.G. Allergy Work-Up Including Component-Resolved Diagnosis: How to Make Allergen-Specific Immunotherapy More Specific // Immunol. Allergy. Clin. North. Am. – 2016. – Vol. 36, No.1. – P. 191–203. DOI: 10.1016/j.iac.2015.08.012.Asero R, Gianni Mistrello G, Amato S. Detection of pan-allergens in commercial pollen extracts for allergen immunotherapy. Ann Allergy Asthma Immunol. Aug;117(2):180–5. DOI: 10.1016/j.anai.2016.05.010.El-Qutob D., Letrán A., Matheu V., Fernandez-Caldas E. Cancer: Still a contraindication for allergen immunotherapy? Specific immunotherapy and cancer // World Allergy Organization Journal. – 2021. – Vol. 14, No.10. – Art. ID: 100597. DOI: 10.1016/j.waojou.2021.100597.Kleine-Tebbe J, Matricardi PM, Hamilton R.G. Allergy Work-Up Including Component-Resolved Diagnosis: How to Make Allergen-Specific Immunotherapy More Specific. Immunol Allergy Clin North Am. 2016;36(1):191–203. DOI: 10.1016/j.iac.2015.08.012.Calderón M.A., Bacharier L.B. Controversies in Allergy: A Pro/Con Review of Sublingual Allergen Immunotherapy and Allergic Asthma // J. Allergy. Clin. Immunol. Pract. – 2021. – Vol. 9, No.5. – P. 1818–1825. DOI: 10.1016/j.jaip.2021.02.029.El-Qutob D, Letrán A, Matheu V, Fernandez-Caldas E. Cancer: Still a contraindication for allergen immunotherapy?: Specific immunotherapy and cancer. World Allergy Organization Journal. 2021;14(10): 100597 DOI: 10.1016/j.waojou.2021.100597.Mailhol C., Didier A. Allergen-specific immunotherapy in the treatment of pollen allergy // Rev. Mal. Respir. – 2013. – Vol. 30, No.2. – P. 142–151. DOI: 10.1016/j.rmr.2012.07.005.Calderón MA, Bacharier LB. Controversies in Allergy: A Pro/Con Review of Sublingual Allergen Immunotherapy and Allergic Asthma. J Allergy Clin Immunol Pract. 2021;9(5):1818–25. DOI: 10.1016/j.jaip.2021.02.029.Cox L. Sublingual immunotherapy for aeroallergens: Status in the United States // Allergy Asthma Proc. – 2014. – Vol. 35, No.1. – Р. 34–42. DOI: 10.2500/aap.2014.35.3708.Mailhol C, Didier A. Allergen-specific immunotherapy in the treatment of pollen allergy. Rev Mal Respir. 2013;30(2):142–51. DOI: 10.1016/j.rmr.2012.07.005.Kinaciyan T., Nagl B., Faustmann S., Frommlet F., Kopp S., Wolkersdorfer M., Wöhrl S., Bastl K., Huber H., Berger U., Bohle B. Efficacy and safety of 4 months of sublingual immunotherapy with recombinant Mal d 1 and Bet v 1 in patients with birch pollen – related apple allergy // J. Allergy Clin. Immunol. – 2018. – Vol. 141, No.3. – P. 1002–1008. DOI: 10.1016/j.jaci.2017.07.036.Cox L. Sublingual immunotherapy for aeroallergens: Status in the United States. Allergy Asthma Proc. 2014;35(1):34–42. DOI: 10.2500/aap.2014.35.3708.Asero R., Mistrello G., Amato S. Detection of pan-allergens in commercial pollen extracts for allergen immunotherapy // Ann. Allergy Asthma Immunol. – 2016. – Vol. 117, No.2. – P. 180–185. DOI: 10.1016/j.anai.2016.05.010.Kinaciyan T, Nagl B, Faustmann S, Frommlet F., Kopp S, Wolkersdorfer M, Wöhrl S, Bastl K, Huber H, Berger U, Bohle B. Efficacy and safety of 4 months of sublingual immunotherapy with recombinant Mal d 1 and Bet v 1 in patients with birch pollen – related apple allergy. J Allergy Clin Immunol. 2018; 141(3):1002–08. DOI: 10.1016/j.jaci.2017.07.036.Rodríguez Del Río P., Díaz-Perales A., Sánchez-García S., Escudero C., Ibáñez M.D., Méndez-Brea P., Barber D. Profilin, a Change in the Paradigm // J. Investig. Allergol. Clin. Immunol. – 2018. – Vol. 28, No.1. – P. 1–12. DOI: 10.18176/jiaci.0193.Asero R, Mistrello G, Amato S. Detection of pan-allergens in commercial pollen extracts for allergen immunotherapy. Ann Allergy Asthma Immunol. 2016; 117(2):180–5. DOI: 10.1016/j.anai.2016.05.010.Codina R., Lockey R.F. Pollen used to produce allergen extracts // Ann. Allergy Asthma Immunol. – 2017. – Vol. 118, No.2. – P. 148–153. DOI: 10.1016/j.anai.2016.02.005.Rodríguez Del Río P, Díaz-Perales A, Sánchez-García S, Escudero C, Ibáñez MD, Méndez-Brea P, Barber D. Profilin, a Change in the Paradigm. J Investig Allergol Clin Immunol. 2018;28(1):1-12. DOI: 10.18176/jiaci.0193.Wang L., Zhang X., Hu J. Proteomic analysis and identification of possible allergenic proteins in mature pollen of populus tomentosa // Int. J. Mol. Sci. – 2018. –Vol. 19, No.1. – Art. No. 250. DOI: 10.3390/ijms19010250.Codina R, Lockey RF. Pollen used to produce allergen extracts. Ann Allergy Asthma Immunol. 2017; 118(2):148–53. DOI: 10.1016/j.anai.2016.02.005.Brier S., Le Mignon M., Jain K., Lebrun C., Peurois F. Kellenberger C., Bordas-Le Floch V., Mascarell L., Nony E., Moingeon P. Characterization of epitope specificities of referenceantibodies used for the quantification of the birch pollenallergen Bet v 1. // Allergy. – 2018. – Vol. 73, No.5. – P. 1032–1040. DOI:10.1111/all.13364.Wang L, Zhang X, Hu J. Proteomic analysis and identification of possible allergenic proteins in mature pollen of populus tomentosa. Int. J. Mol. Sci. 2018;19(1):250 DOI: 10.3390/ijms19010250.Costa J., Bavaro S.L., Benedé S., Diaz-Perales A., Bueno-Diaz C., Gelencser E., Klueber J., Larré C., Lozano-Ojalvo D., Lupi R., Mafra I., Mazzucchelli G., Molina E., Monaci L., Martín-Pedraza L., Piras C., Rodrigues P.M., Roncada P., Schrama D., Cirkovic-Velickovic T., Verhoeckx K., Villa C., Kuehn A., Hoffmann-Sommergruber K., Holzhauser T. Are Physicochemical Properties Shaping the Allergenic Potency of Plant Allergens? // Clin. Rev. Allergy Immunol. – 2022. – Vol. 62, No.1. – P. 37–63. DOI: 10.1007/s12016-020-08810-9.Brier S, Le Mignon M, Jain K, Lebrun C, Peurois F, Kellenberger C, Bordas-Le Floch V, Mascarell L, Nony E, Moingeon P. Characterization of epitope specificities of reference antibodies used for the quantification of the birch pollen allergen Bet v 1. Allergy. 2018;73:1032–40. DOI: 10.1111/all.13364.Kailaivasan T., Davies J.M. The molecular allergology of subtropical grass pollen // Mol. Immunol. – 2018. – Vol. 100. – P. 126–135. DOI: 10.1016/j.molimm.2018.03.012.Costa J, Bavaro SL, Benedé S, Diaz-Perales A, Bueno-Diaz C, Gelencser E, Klueber J, Larré C, Lozano-Ojalvo D, Lupi R, Mafra I, Mazzucchelli G, Molina E, Monaci L, Martín-Pedraza L, Piras C, Rodrigues PM, Roncada P, Schrama D, Cirkovic-Velickovic T, Verhoeckx K, Villa C, Kuehn A, Hoffmann-Sommergruber K, Holzhauser T. Are Physicochemical Properties Shaping the Allergenic Potency of Plant Allergens? Clin Rev Allergy Immunol. 2022;62(1):37–63. DOI: 10.1007/s12016-020-08810-9.Klimek L., Brehler R., Hamelmann E., Kopp M., Ring J., Treudler R., Jakob T., Worm M., Pfaar O. Development of subcutaneous allergen immunotherapy (part 2): preventive aspects and innovations // Allergo J. Int. – 2019. – Vol. 28. – P. 107–119. DOI: 10.1007/s40629-019-0097-z.Kailaivasan T, Davies JM. The molecular allergology of subtropical grass pollen. Mol Immunol. 2018;100:126–35. DOI: 10.1016/j.molimm.2018.03.012.Zimmer J., Bridgewater J., Ferreira F., van Ree R., Rabin R.L., Vieths S. The History, Present and Future of Allergen Standardization in the United States and Europe // Front. Immunol. – 2021. – Vol. 12. – Art ID: 725831. DOI: 10.3389/fimmu.2021.725831.Klimek L., Brehler R., Hamelmann E., Kopp M., Ring J., Treudler R., Jakob T., Worm M., Pfaar O. Development of subcutaneous allergen immunotherapy (part 2): preventive aspects and innovations. Allergo J Int. 2019;28:107–19. DOI: 10.1007/s40629-019-0097-z.Nelson H.S. Allergy immunotherapy: Future directions for the 2020s // Allergy Asthma Proc. – 2020. – Vol. 41, No.5. – Р. 314–325. DOI: 10.2500/aap.2020.41.200041.Zimmer J, Bridgewater J, Ferreira F, van Ree R, Rabin RL, Vieths S. The History, Present and Future of Allergen Standardization in the United States and Europe. Front Immunol. 2021;12:725831. DOI: 10.3389/fimmu.2021.725831.Игнатов А.А., Раменская Г.В., Смирнов В.В. Современные тенденции в стандартизации препаратов аллергенов // Фармакокинетика и фармакодинамика. – 2015. – №1. – С.16–20.Nelson HS. Allergy immunotherapy: Future directions for the 2020s. Allergy Asthma Proc. 2020 Sep 1;41(5):314–25 DOI: 10.2500/aap.2020.41.200041Codina R. Crenshaw R. C., Lockey R. F. Considerations About Pollen Used for the Production of Allergen Extracts // J. Allergy Clin. Immunol. Pract. – 2015. – Vol. 3, No.5. – P. 676–682. DOI: 10.1016/j.jaip.2015.04.003.Ignatov AA, Ramenskaya GV, Smirnov VV. Sovremennye tendencii v standartizacii preparatov allergenov. [Farmakokinetika i farmakodinamika]. Pharmacokinetics and pharmacodynamics. 2015; 1:16–20 RussianD’Amato G., Cecchi L., Bonini S., Nunes C., Annesi-Maesano I., Behrendt H., Liccardi G., Popov T., van Cauwenberge P. Allergenic pollen and pollen allergy in Europe // Allergy. – 2007. – Vol. 62, No.9. – P. 976–990. DOI: 10.1111/j.1398-9995.2007.01393.x.Codina R, Crenshaw RC, Lockey RF. Considerations About Pollen Used for the Production of Allergen Extracts. J Allergy Clin Immunol Pract. 2015; 3 (5):676–82. DOI: 10.1016/j.jaip.2015.04.003Larsen J.M., Bang-Berthelsen C.H., Qvortrup K., Sancho A.I., Hansen A.H., Andersen K.I.H., Thacker S.S.N., Eiwegger T., Upton J., Bøgh K.L. Production of allergen-specific immunotherapeutic agents for the treatment of food allergy // Crit. Rev. Biotechnol. – 2020. – Vol. 40, No.6. – P. 881–894. DOI: 10.1080/07388551.2020.1772194.Amato D’Amato G, Cecchi L, Bonini S, Nunes C, Annesi-Maesano I, Behrendt H, Liccardi G, Popov T, van Cauwenberge P. Allergenic pollen and pollen allergy in Europe. Allergy. 2007;62(9):976–90. DOI: 10.1111/j.1398-9995.2007.01393.x.Rossi R.E., Monasterolo G., Coco G., Operti D. Possible relationship between systemic side effects and sensitization to rPar j 2 in allergic patients submitted to an ultra-rush (20 min) sublingual immunotherapy and selected by component resolved diagnosis // Int. Arch. Allergy Immunol. – 2005. – Vol. 138, No.2. – P. 105–110. DOI: 10.1159/000088431.Larsen JM, Bang-Berthelsen CH, Qvortrup K, Sancho AI, Hansen AH, Andersen KIH, Thacker SSN, Eiwegger T, Upton J, Bøgh KL. Production of allergen-specific immunotherapeutic agents for the treatment of food allergy. Crit Rev Biotechnol. 2020;40(6):881–94. DOI: 10.1080/07388551.2020.1772194.Петрова С.Ю., Хлгатян С.В., Бержец В.М., Васильева А.В. Аллергенсодержащие вакцины для специфической иммунотерапии // Журнал микробиологии, эпидемиологии и иммунобиологии. – 2021. – Т.98, №1. – С. 104-112. DOI: 10.36233/0372-9311-11.Rossi RE, Monasterolo G, Coco G, Operti D. Possible relationship between systemic side effects and sensitization to rPar j 2 in allergic patients submitted to an ultra-rush (20 min) sublingual immunotherapy and selected by component resolved diagnosis. Int Arch Allergy Immunol. 2005;138(2):105–10. DOI: 10.1159/000088431Starchenka S., Heath M.D., Lineberry A., Higenbottam T., Skinner M.A. Transcriptome analysis and safety profile of the early-phase clinical response to an adjuvanted grass allergoid immunotherapy // World Allergy Org. J. – 2019. – Vol. 12, No.11. – Art. ID: 100087. DOI: 10.1016/j.waojou.2019.100087.Petrova SYu, Hlgatyan SV, Berzhec VM, Vasil’eva AV. Allergensoderzhashchie vakciny dlya specificheskoj immunoterapii. [ZHurnal mikrobiologii, epidemiologii i immunobiologii]. Journal of Microbiology, Epidemiology and Immunobiology. 2021;98(1):104–12. DOI: 10.36233/0372-9311-11 RussianCudowska B., Kapingidza A.B., Pawłowicz M., Pampuch A., Hyduke N., Pote S., Schlachter C.R., Lebensztejn D.M., Chruszcz M., Kowal K. Production and Use of Recombinant Profilins Amb a 8, Art v 4, Bet v 2, and Phl p 12 for Allergenic Sensitization Studies // Molecules. – 2020. – Vol. 25, No.2. – Art. No.369. DOI: 10.3390/molecules25020369.Starchenka S, Heath MD, Lineberry A, Higenbottam T, Skinner MA.Transcriptome analysis and safety profile of the early-phase clinical response to an adjuvanted grass allergoid immunotherapy. World Allergy Org J. 2019; 12(11):100087. DOI: 10.1016/j.waojou.2019.100087.O’Malley A., Kapingidza A.B., Hyduke N., Dolamore C., Kowal K., Chruszcz M. Crystal structure of timothy grass allergen Phl p 12.0101 reveals an unusual profilin dimer // Acta Biochim. Pol. – 2021. – Vol. 68, No. 1. – Р. 15–22. DOI: 10.18388/abp.2020_5587.Cudowska B, Kapingidza AB, Pawłowicz M, Pampuch A, Hyduke N, Pote S, Schlachter CR, Lebensztejn DM, Chruszcz M, Kowal K. Production and Use of Recombinant Profilins Amb a 8, Art v 4, Bet v 2, and Phl p 12 for Allergenic Sensitization Studies. Molecules. 2020; 25(2):369. DOI: 10.3390/molecules25020369.Taube A.A., Gilyok M.T., Sakanyan E.I. Methodological Approaches to Improving the Quality of Medicinal Plant Raw Materials of the Pollen Morphology Group // Pharm. Chem. J. – 2022. – Vol. 55, No.12. – Р. 1407–1411. DOI: 10.1007/s11094-022-02589-z.O’Malley A, Kapingidza AB, Hyduke N, Dolamore C, Kowal K, Chruszcz M. Crystal structure of timothy grass allergen Phl p 12.0101 reveals an unusual profilin dimer. Acta Biochim Pol. 2021;68(1):15–22. DOI: 10.18388/abp.2020_5587.Park J.W., Jeong K. Y. Allergen standardization // Allergy Asthma Respir. Dis. – 2018. – Vol. 6, No.4. – P. 191–196. DOI: 10.4168/aard.2018.6.4.191.Taube AA, Gilyok MT, Sakanyan EI Methodological Approaches to Improving the Quality of Medicinal Plant Raw Materials of the Pollen Morphology Group. Pharm Chem J. 2022;55(12): 1407–11. DOI: 10.1007/s11094-022-02589-z.Солдатов А.А., Медуницын Н.В., Авдеева Ж.И., Бондарев В.П., Миронов А.Н. Препараты лечебных аллергенов: проблемы и пути повышения качества, безопасности и эффективности // Ведомости НЦЭСМП. – 2013. – № 4. – С. 31–37.Park J-W, Jeong K-Y. Allergen standardization. Allergy Asthma Respir Dis. 2018;6(4):191–6. DOI: 10.4168/aard.2018.6.4.191Федоров А.С., Литвинова Л.С., Бут-Гусаим В.И., Литвиненко С.Н. Аллерген-специфическая иммунотерапия: терапевтические вакцины для аллергических заболеваний // Медицинская иммунология. – 2015. – Т. 17, №5. – С. 407–422.Soldatov AA, Medunicyn NV, Avdeeva ZHI, Bondarev VP, Mironov AN. Preparaty lechebnyh allergenov: problemy i puti povysheniya kachestva, bezopasnosti i effektivnosti. [Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya. Regulyatornye issledovaniya i ekspertiza lekarstvennykh sredstv]. Bull Scie Centre Expert Eval Med Prod. 2013; 4:31–7. RussianYang Y.Sh., Xu Z.Q., Zhu W., Zhu D.X., Jiao Y.X., Zhang L.Sh., Hou Y.B., Wei J.F., Sun J.L. Molecular and immunochemical characterization of profilin as major allergen from Platanus acerifolia pollen // Int. Immunopharmacology. – 2022. – Vol. 106. – Art. No. 108601. DOI: 10.1016/j.intimp.2022.108601.Fedorov AS, Litvinova LS, But-Gusaim VI, Litvinenko SN. Allergen-specificheskaya immunoterapiya: terapevticheskie vakciny dlya allergicheskih zabolevanij. [Medicinskaya immunologiya]. Medic Immunol. 2015;17(5):407–22. RussianCaraballo L., Valenta R., Acevedo N., Zakzuk J. Are the TermsMajor and Minor Allergens Useful for Precision Allergology? // Front. Immunol. – 2021. – Vol.12. – Art. ID: 651500. DOI: 10.3389/fimmu.2021.651500.Yang YSh, Xu ZQ, Zhu W, Zhu DX, Jiao YX, Zhang LSh, Hou YB, Wei JF, Sun JL. Molecular and immunochemical characterization of profilin as major allergen from Platanus acerifolia pollen. Int Immunopharmacology. 2022;106:108601. DOI: 10.1016/j.intimp.2022.108601.Landa-Pineda C.M., Arroyo-Becerra A., Rosas-Alvarado A., Terán L.M., Garcia-Cruz M.L., Marchat L.A., Reyes-López C.A. Major allergen from Amaranthus palmeri pollen is a profilin: Isolation, partial characterisation and IgE recognition // Allergol. Immunopathol (Madr).– 2006. – Vol. 44, No.2. – P. 160–166. DOI: 10.1016/j.aller.2015.05.002.Caraballo L, Valenta R, Acevedo Nand Zakzuk J Are the TermsMajor and Minor Allergens Useful for Precision Allergology? Front Immunol. 2021;12:651500. DOI: 10.3389/fimmu.2021.651500.D’Amato G. The effects of climate change on respiratory allergy and asthma induced by pollen and mold allergens // Allergy. – 2020. – Vol. 75, No.9. – P. 2219–2228. DOI: 10.1111/all.14476.Landa-Pineda CM, Arroyo-Becerra A, Rosas-Alvarado A, Terán LM, Garcia-Cruz ML, Marchat LA, Reyes-López CA. Major allergen from Amaranthus palmeri pollen is a profilin: Isolation, partial characterisation and IgE recognition // Allergol Immunopathol (Madr). 2006;449(2):160–6.Fernández-Caldas E., Carnés J., Iraola V., Casanovas M. Comparison of the allergenicity and Ole e 1 content of 6 varieties of Olea europaea pollen collected during 5 consecutive years // Ann. Allergy Asthma Immunol. – 2007. – Vol. 98, No.5. – P. 464–470. DOI: 10.1016/S1081-1206(10)60761-2.DOI: 10.1016/j.aller.2015.05.002Weber R.W. Cross-reactivity of plant and animal allergens // Clin. Rev. Allergy Immunol. – 2001. – Vol. 21, No.2–3. – P. 153–202. DOI: 10.1385/CRIAI:21:2-3:153.D’Amato G. The effects of climate change on respiratory allergy and asthma induced by pollen and mold allergens. Allergy. 2020;75(9):2219–28. DOI: 10.1111/all.14476.Daigle B.J., Rekkerth D. J Practical recommendations for mixing allergy immunotherapy extracts // Allergy Rhinol. (Providence). – 2015. – Vol. 6, No.1. – P. 1–7. DOI: 10.2500/ar.2015.6.0111.Fernández-Caldas E, Carnés J, Iraola V, Casanovas M. Comparison of the allergenicity and Ole e 1 content of 6 varieties of Olea europaea pollen collected during 5 consecutive years. Ann Allergy Asthma Immunol. 2007 May;98(5):464–70. DOI: 10.1016/S1081-1206(10)60761-2.Sastre J., Rodríguez F., Campo P., Laffond E., Marín A., Alonso M.D. Adverse reactions to immunotherapy are associated with different patterns of sensitization to grass allergens // Allergy. – 2015. – Vol. 70, No.5. – P. 598–600. DOI: 10.1111/all.12575.Weber RW. Cross-reactivity of plant and animal allergens. Clin Rev Allergy Immunol. 2001 Oct;21(2–3):153–202. DOI: 10.1385/CRIAI:21:2-3:153.Mitobe Y., Yokomoto Y., Ohashi-Doi K. Safety evaluation of standardized allergen extract of Japanese cedar pollen for sublingual immunotherapy // Regul. Toxicol. Pharmacol. – 2015. – Vol. 71, No.3. – P. 529–540. DOI: 10.1016/j.yrtph.2015.02.009.Daigle BJ, Rekkerth DJ. Practical recommendations for mixing allergy immunotherapy extracts. Allergy Rhinol (Providence). 2015 Jan;6(1):1–7. DOI: 10.2500/ar.2015.6.0111.Canonica G.W., Cox L., Pawankar R., Baena-Cagnani C.E., Blaiss M., Bonini S., Bousquet J., Calderón M., Compalati E., Durham S.R., van Wijk, R.G.Larenas-Linnemann D., Nelson H., Passalacqua G., Pfaar O., Rosário N., Ryan D., Rosenwasser L., Schmid-Grendelmeier P., Senna G., Valovirta E., Van Bever H., Vichyanond P., Wahn U., Yusuf O. Sublingual Immunotherapy: World Allergy Organization Position Paper 2013 // World Allergy Organ. J. – 2014. – Vol. 7, No.6. – P. 4–52. DOI: 10.1186/1939-4551-7-6.Sastre J, Rodríguez F, Campo P, Laffond E, Marín A, Alonso MD. Adverse reactions to immunotherapy are associated with different patterns of sensitization to grass allergens. Allergy. 2015;70(5):598–600. DOI: 10.1111/all.12575.Боков Д.О., Боков В.В., Смирнов Н.Б., Демина Н.Б. Производство и стандартизация пыльцевых аллергенных экстрактов // Разработка и регистрация лекарственных средств. – 2014. – Т.4, №9. – С. 68–83.Mitobe Y, Yokomoto Y, Ohashi-Doi K. Safety evaluation of standardized allergen extract of Japanese cedar pollen for sublingual immunotherapy. Regul Toxicol Pharmacol. 2015 April;71(3):529–40. DOI: 10.1016/j.yrtph.2015.02.009Kostić A.Z., Milinčić D.D., Petrović T.S., Krnjaja V.S., Stanojević S.P., Barać M.B., Tešić Z.L., Pešić M.B. Mycotoxins and Mycotoxin Producing Fungi in Pollen: Review // Toxins (Basel). – 2019. – Vol. 24, No.11(2). – Art. No.64. DOI: 10.3390 / toxins11020064.Canonica GW, Cox L, Pawankar R, Baena-Cagnani CE, Blaiss M, Bonini S, Bousquet J, Calderón M, Compalati E, Durham S.R, van Wijk R.G, Larenas-Linnemann D, Nelson H, Passalacqua G, Pfaar O, Rosário N, Ryan D, Rosenwasser L, Schmid-Grendelmeier P, Senna G, Valovirta E, Van Bever H, Vichyanond P, Wahn U, Yusuf O. Sublingual Immunotherapy: World Allergy Organization Position Paper. 2013 update. World Allergy Organ J. 2014;7(6):4–52. DOI:10.1186/1939-4551-7-6Bokov DO, Smirnov VV, Demina NB. Proizvodstvo i standartizaciya pyl’cevyh allergennyh ekstraktov // Razrabotka i registraciya lekarstvennyh sredstv=Drug development & registration. 2014;4(9): 68–83.Bokov DO, Smirnov VV, Demina NB. Proizvodstvo i standartizaciya pyl’cevyh allergennyh ekstraktov // Razrabotka i registraciya lekarstvennyh sredstv=Drug development & registration. 2014;4(9): 68–83.Kostić AZ, Milinčić DD,Petrović TS, Krnjaja VS, Stanojević SP, Barać MB, Tešić ZL, Pešić MB. Mycotoxins and Mycotoxin Producing Fungi in Pollen: Review. Toxins (Basel). 2019 Jan 24; 24(11(2)):64. DOI: 10.3390 / toxins11020064.Kostić AZ, Milinčić DD,Petrović TS, Krnjaja VS, Stanojević SP, Barać MB, Tešić ZL, Pešić MB. Mycotoxins and Mycotoxin Producing Fungi in Pollen: Review. Toxins (Basel). 2019 Jan 24; 24(11(2)):64. DOI: 10.3390 / toxins11020064.

The authors declare that there are no conflicts of interest present.