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Abstract

Since they were developed, monoclonal antibodies have been studied for potential therapeutic use. The forefront of modern medicine's move towards a new era of individualized therapy is the use of monoclonal antibodies to treat a range of ailments. Monoclonal antibodies can be employed for therapeutic, imaging, and diagnostic applications and have a very high clinical significance. Monoclonal antibodies have a variety of intriguing potential clinical uses. Because the monoclonal antibodies used were either produced in mice or rats, there is currently a risk of disease transfer from mice to people. There is no proof that the antibodies created by this procedure are completely virus-free, despite the refining process. Hybridoma technology is a common method for making monoclonal antibodies. Immunized mice are removed from their antibody-producing B lymphocytes and combined with immortal myeloma cell lines to produce hybrid cells, also referred to as hybridoma cell lines. One of the cutting-edge methods that have assisted in easing some of these limitations is genetic engineering. Modern methods are being developed to make lab-made monoclonal antibodies as similar to human as possible. This overview discusses the creation, therapeutic significance, and possible applications of monoclonal antibodies as well as their benefits and challenges. This review will focus on the historical development of monoclonal antibodies, including how it transitioned from time-consuming animal models to a more effective phage display system, some of the major clinical and financial drawbacks, and potential future innovations that are currently being studied to maximize their efficacy for use in the clinic. This review article has been prepared using various references from Google Scholar and Search Engine

Keywords

Monoclonal antibodies; Hybridomas ; Immunization ; Therapeutic antibodies

Reference

  1. National Research Council (US) Committee on Methods of Producing Monoclonal Antibodies. Monoclonal Antibody Production. Washington (DC): National Academies Press (US); 1999. COMMITTEE ON METHODS OF PRODUCINGMONOCLONAL ANTIBODIES. Available from: https://www.ncbi.nlm.nih.gov/books/NBK100201/
  2. Kumagai Izumi and Tsumoto Kouhei (Published- 19 April 2010) ‘Antigen-Antibody Binding’ Introduction pg-1, Wiley Online Library, Available from: https://doi.org/10.1002/9780470015902.a0001117.pub2
  3. Ratheesh Krishna Kripa, ’Antigen and Antibody Reaction’ June 30, 2019 SlideShare, Definition of Antigen-2. Available from:  https://www.slideshare.net/Ratheeshrikrishnakripa/antigen-antibody-reaction-152721326
  4. Ehrlich Paul 1900 Croonian lecture. On immunity with special reference to cell life Proc. R. Soc. Lond.66:424–448 Available from: http://doi.org/10.1098/rspl.1899.0121
  5. Nelson, A., Dhimolea, E. Reichert, J. Development trends for human monoclonal antibody therapeutics. Nat Rev Drug Discov 9, 767–774 (2010). Available from:  https://doi.org/10.1038/nrd3229
  6. Maggon K. ‘Monoclonal antibody’ "gold rush". Curr Med Chem. 2007;14(18):1978-87. Doi: 10.2174/092986707781368504. PMID: 17691940. Available from: https://pubmed.ncbi.nlm.nih.gov/17691940/
  7. Li, J., Zhu, Z. Research and development of next generation of antibody-based therapeutics. Acta Pharmacol Sin 31, 1198–1207 (2010). Available from: https://doi.org/10.1038/aps.2010.120
  8. KÖHLER, G., MILSTEIN, C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 256, 495–497 (1975). Available from: https://doi.org/10.1038/256495a0
  9. Berger M, Shankar V, Vafai A. Therapeutic applications of monoclonal antibodies. Am J Med Sci. 2002 Jul;324(1):14-30. Doi: 10.1097/00000441-200207000-00004. PMID: 12120821; PMCID: PMC7093874.
  10. Milstein C. With the benefit of hindsight. Immunol Today. 2000 Aug;21(8):359-64. Doi: 10.1016/s0167-5699(00)01660-1. PMID: 10916137.
  11. Little M, Kipriyanov SM, Le Gall F, Moldenhauer G. Of mice and men: hybridoma and recombinant antibodies. Immunol Today. 2000 Aug;21(8):364-70. Doi: 10.1016/s0167-5699(00)01668-6. PMID: 10916138.
  12. Li F, Vijaya Sankaran N, Shen AY, Kiss R, Amanullah A. Cell culture processes for monoclonal antibody production. MAbs. 2010 Sep-Oct;2(5):466-79. Doi: 10.4161/mabs.2.5.12720. Epub 2010 Sep 1. PMID: 20622510; PMCID: PMC2958569.
  13. Mitra S, Tomar PC. Hybridoma technology; advancements, clinical significance, and future aspects. J Genet Eng Biotechnol. 2021 Oct 18;19(1):159. Doi: 10.1186/s43141-021-00264-6. PMID: 34661773; PMCID: PMC8521504.
  14. Clementi N, Mancini N, Solforosi L, Castelli M, Clementi M, Burioni R. Phage display-based strategies for cloning and optimization of monoclonal antibodies directed against human pathogens. Int J Mol Sci. 2012;13(7):8273-8292. Doi: 10.3390/ijms13078273. Epub 2012 Jul 4. PMID: 22942702; PMCID: PMC3430233.
  15. Schofield DJ, Pope AR, Clementel V, Buckell J, Chapple SDj, Clarke KF, et.al. Application of phage display to high throughput antibody generation and characterization. Genome Biol. 2007;8(11): R254. Doi: 10.1186/gb-2007-8-11-r254. PMID: 18047641; PMCID: PMC2258204.
  16. Schirrmann T, Meyer T, Schütte M, Frenzel A, Hust M. Phage display for the generation of antibodies for proteome research, diagnostics and therapy. Molecules. 2011 Jan 10;16(1):412-26. Doi: 10.3390/molecules16010412. PMID: 21221060; PMCID: PMC6259421.
  17. Watkins NA, Ouwehand WH. Introduction to antibody engineering and phage display. Vox Sang. 2000;78(2):72-9. Doi: 10.1159/000031154. PMID: 10765141.
  18. Hoogenboom HR, Chames P. Natural and designer binding sites made by phage display technology. Immunol Today. 2000 Aug;21(8):371-8. Doi: 10.1016/s0167-5699(00)01667-4. PMID: 10916139.
  19. Chistensen D J, Gottlin E B, Benson R E. (2001). “Phage display for target-based antibacterial drug discovery”. Drug Discovery Today 6(14):721-727.  Available from: https://www.creative-biolabs.com/drug-discovery/therapeutics/hts-based-on-phage-display.htm
  20. Sophie LE RAY, ProteoGenix, ‘Hybridoma vs Phage Display Technology’ Industry Insights published- Jan 30,2019. Available from:https://www.technologynetworks.com/drug-discovery/blog/hybridoma-vs-phage-display-for-monoclonal-antibody-production-which-technique-for-which-purpose-314741
  21. Schur PH. IgG subclasses--a review. Annals of Allergy. 1987 Feb;58(2):89-96, 99. PMID: 3544971.
  22. Spiegelberg HL. Biological activities of immunoglobulins of different classes and subclasses. Adv Immunol. 1974;19(0):259-94. Doi: 10.1016/s0065-2776(08)60254-0. PMID: 4611173.
  23. C Molnar.2015 ‘23.3. Antibodies -Concepts of Biology’ BCcampus open publishing. Available from: https://opentextbc.ca/biology/chapter/23-3-antibodies/
  24. US-FDA Guidance Document- Points to consider in manufacture and testing of Monoclonal Antibody Production for human use, February 1997, Docket number- FDA-1994-D-0318, Issued by- Centre for Biologics Evaluation and Research, Centre for Drug Evaluation and Research, USFDA. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/points-consider-manufacture-and-testing-monoclonal-antibody-products-human-use
  25. US-FDA Guidance Document- S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals, November 1997, Docket number- FDA-1997-D-0265, Issued by- Centre for Biologics Evaluation and Research, Centre for Drug Evaluation and Research, USFDA. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/s6-preclinical-safety-evaluation-biotechnology-derived-pharmaceuticals
  26. Omudhome Ogbru and Charles Patrick, ‘Monoclonal Antibodies’, Medicine Net, medically reviewed-10/12/2022. Available from:https://www.medicinenet.com/monoclonal_antibodies/drug-class.htm
  27. Sandhya P., Nicholas D.,Nandan S.,Aminda S.,Jamie N.,Misbah B. et.al, ‘ Monoclonal Antibody drugs for cancer: How they Work’. Available from:  https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/monoclonal-antibody/art-200047808
  28. Foltz IN, Karow M, Wasserman SM. Evolution and emergence of therapeutic     

monoclonal antibodies: what cardiologists need to know. Circulation. 2013 Jun 4;127(22):2222-30. Doi: 10.1161/CIRCULATIONAHA.113.002033. PMID: 23733968.

29. Guimaraes Koch SS, Thorpe R, Kawasaki N, Lefranc MP, Malan S, Martin ACR, et.al. International non-proprietary names for monoclonal antibodies: an evolving nomenclature system. MAbs. 2022 Jan-Dec;14(1):2075078. Doi: 10.1080/19420862.2022.2075078. PMID: 35584276; PMCID: PMC9122354.

30. Cancer available from – https://www.cancer.gov/about- cancer/understanding/what-is-cancer

31. Bethesda (MD)- LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Antineoplastic Agents. [Updated 2023 Feb 13]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK548022/

  1. Cerny T, Borisch B, Introna M, Johnson P, Rose AL. Mechanism of action of rituximab. Anticancer Drugs. 2002 Nov;13 Suppl 2: S3-10. Doi: 10.1097/00001813-200211002-00002. PMID: 12710585.
  2. Faith S., Yuette Brazier and Tom Rush, ‘What are the different types of tumours?’, by- Medical News Today, Updated on- February 10, 2023. Available from: https://www.medicalnewstoday.com/articles/249141
  3.  Available From– https://medlineplus.gov/ency/article/000816.htm
  4. Puthenpurail A, Rathi H, Nauli SM, Ally A. A BRIEF SYNOPSIS OF MONOCLONAL ANTIBODY FOR THE TREATMENT OF VARIOUS GROUPS OF DISEASES. World J Pharm Sci. 2021 Nov;10(11):14-22. PMID: 35071113; PMCID: PMC8775886.
  5. Rituximab- 20 September 2020. Available from: https://nras.org.uk/resource/b-cell-inhibitor-rituximab/?print-pdf=3455
  6. Asthma: Types, Causes, Symptoms, Diagnosis and Treatment – 19 Jan 2022. Available from: https://my.clevelandclinic.org/health/diseases/6424-asthma
  7. Kumar C, Zito PM. Omalizumab. [Updated 2023 Aug 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK545183/
  8. Omalizumab Mechanism of Action Available From – https://www.uptodate.com/contents/image?imageKey=ALLRG/59320
  9. Darragh O’ Carroll and S.Srakocic, ‘Monoclonal Antibody Treatment for COVID-19’- Healthline Media September 21,2022. Available from: https://www.healthline.com/health/what-is-monoclonal-antibody-treatment
  10. Kauvery hospital- July 16,2021,”Monoclonal antibody treatment used for COVID-19”. Available from: https://kauveryhospital.com/blog/vaccination/monoclonal-antibodies-and-covid-19-treatment/
  11. Nandkishhor Jha, “Applications of monoclonal antibodies : 4 applications”. Available from – https://www.biologydiscussion.com/biotechnology/applications-of- monoclonal-antibodies-4-applications/10045
  12. Himal Barakoti,‘Monoclonal Antibodies: Preparation, Evaluation and Application’, SlideShare-9,10 – February 06,2019. Available from: https://www.slideshare.net/HimalBarakoti/monoclonal-antibodies-130716465
  13. Sepmag, ‘Protein Purification: the step-by-step process’ – April 28,2022. Available from: https://www.sepmag.eu/blog/bid/371789/the-step-by-step-process-of-protein-purification

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TIWARI POOJA
Corresponding author

ROFEL SHRI G.M. BILAKHIA COLLEGE OF PHARMACY, NAMDHA ROAD VAPI, VALSAD, GUJARAT-396191

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PATEL PRATIXA
Co-author

ROFEL SHRI G.M. BILAKHIA COLLEGE OF PHARMACY, NAMDHA ROAD VAPI, VALSAD, GUJARAT-396191

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MISHRA SATYAM
Co-author

ROFEL SHRI G.M. BILAKHIA COLLEGE OF PHARMACY, NAMDHA ROAD VAPI, VALSAD, GUJARAT-396191

Photo
YADAV RUBI
Co-author

ROFEL SHRI G.M. BILAKHIA COLLEGE OF PHARMACY, NAMDHA ROAD VAPI, VALSAD, GUJARAT-396191

Pooja Tiwari, Patel Pratixa, Mishra Satyam, Yadav Rubi, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 12, 21-34. https://doi.org/10.5281/zenodo.10251264

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