Monoclonal antibodies are antibodies that are directed against a specific antigen. They are produced by a single clone of cells and can be obtained from immortalized B-lymphocytes or recombinant cell lines. The production of monoclonal antibodies involves immunizing an animal, fusing its spleen cells with myeloma cells to form hybridomas, selecting hybridomas that secrete the desired antibody, and propagating these cells to produce large amounts of monoclonal antibodies. Monoclonal antibodies have various applications in cancer therapy, organ transplantation, disease diagnosis, and protein purification. Recent developments include FDA approvals of monoclonal antibodies for treating cancer and blood disorders.

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MONOCLONAL ANTIBODIES
PRESENTED BY: SRIJA BOSE, SRIDEBESH GHORUI
ROLL NO.:18601916033,18601916034
REGISTRATION NO.: 161860210106,161860210105
B.PHARM, 3RD YEAR,6TH SEMESTER,SECTION-A
GURU NANAK INSTITUTE OF PHARMACEUTICAL SCIENCE AND TECHNOLOGY

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 Introduction
 Principle for the creation of hybridoma cells
 Production of monoclonal antibody
 Principles of HAT selection
 Applications of monoclonal antibodies
 Latest news on monoclonal antibodies
 Conclusions
 References

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INTRODUCTION
Monoclonal antibody (MAb) is a single type of
antibody that is directed against a specific
antigenic determinant(epitope).
MAbs are immunoglobulins or a fragment of an
immunoglobin produced by a single clone of cells.
They can be obtained from immortalized B-
lymphocytes that are cloned and expanded as
continuous cell lines(murine and human
monoclonal antibodies) or from rDNA engineered
mammalian or bacterial cell lines(engineered
monoclonal antibodies).
When a foreign body or antigen molecule enters
into the body, the immune response begins.

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PRODUCTION OF MONOCLONALANTIBODY
• The establishment of hybridomas and production of MAbs involves the following steps:
1. Immunization
2. Cell fusion
3. Selection of hybridomas
4. Screening the products
5. Cloning and propagation
6. Characterization and storage

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PRODUCTION OF MONOCLONALANTIBODY

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PRINCIPLE FOR THE CREATION OF HYBRIDOMA CELLS
• Hybridoma cells can be produced by the fusion of an
antibody producing cell and a myeloma cell.
• The mammalian cells can synthesize nucleotides by two
pathways:-
A)De novo synthesis
B)Salvage pathway

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PRINCIPLES OF HAT SELECTION
1. When the major synthetic pathways are blocked by the folic acid analogue aminopterin, the cell should
employ the salvage pathway. This pathway essentially contains the enzyme HGPRT.
2. HGPRT- cells die in the presence of HAT because both the major synthetic pathway and the salvage
pathway are blocked virtually.
3. Fusion of the HGPRT- myeloma cells with the HGPRT+ spleen cells allows growth in HAT by
incorporating the missing enzyme for the salvage pathway.

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HAT SELECTION

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APPLICATIONS OF MONOCLONALANTIBODIES
• Cancer therapy or immunotoxicology
• Bone marrow transplantation
• Organ transplantation
• Protein purification
• Disease diagnosis
• Gene cloning and expression

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LATEST NEWS ON MONOCLONALANTIBODIES
• MAb pembrolizumab prolongs the survival in patients with squamous cell
carcinoma.(Review on JAN 18,2019)
• Tychan has successfully conducted the Phase 1 trial of TY014, a first-in-class monoclonal
antibody candidate treatment for yellow fever. (13th DEC 2018)
• The meta-analysis of 10 randomized controlled trials has confirmed that human MAb
denosumab can more effectively increase the bone mass in patients with low bone mineral
density or osteoporosis. Any other biphosphate therapy can not do. (13th DEC 2018)
• Sarlumab developed in collaboration with Sanofi and Regeneron Pharmaceuticals, is a MAb
targeting interleukin 6 receptors approved by the FDA. (May 2017)
• Roche’s Emicizumab, the last approved MAb drug in 2017, targets the coagulation factors IXa
and X, thereby promoting the clotting process.

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CONCLUSIONS
• Pathogens can be detected in a small number of hours sparing few days of
culturing of cells.
• Since for the human health care, the subject of production and use of antibodies
has become a very important area of research, not only for the academic purpose
but also for its relevance to industrial growth for diagnosis and therapeutics, MAb
can be utilized for it.
• MAb technology in conjunction with recombinant DNA technology has
successfully led to the reconstruction of chimeric, humanized and fully human
antibodies.

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REFERENCES
• ‘Sambamurthy K., Kar Ashutosh’, “Pharmaceutical Biotechnology” Reprint of First Edition:
2008, New Age International (P) Ltd. Publishers, ISBN:81-224-1911-9, Chapter 1: Immunology
and Immunological Preparations, Subunit 5: Antigen Antibodies Reactions and Their
Applications (5.1.5 Monoclonal Antibodies), Page 53-58.
• Dr. U Satyanarayana, “Biotechnology” Reprint Of First Edition:2010, Books And Allied (P)
Ltd., ISBN:81-87134-909, Chapter17 Monoclonal Antibody (Hybridoma Technology) Page-
213-214.

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