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  1. 1. BIOPHARMACEUTICALS<br />Presented by : Sheetal Narkar <br />
  2. 2. CONTENTS<br /><ul><li>What are biopharmaceuticals?
  3. 3. Classification of Biopharmaceuticals
  4. 4. INTERFERONS :</li></ul>Introduction <br />Mode of Action<br />Commercial Production<br /><ul><li>Advantages of Biopharmaceuticals
  5. 5. Applications of Biopharmaceuticals
  6. 6. Conclusion </li></li></ul><li>BIOPHARMACEUTICALS<br /><ul><li>Biopharmaceuticals are medical drugs produced using Biotechnology.
  7. 7. These are :
  8. 8. Proteins (Antibodies)
  9. 9. Nucleic Acids (DNA, RNA)
  10. 10. Insulin – First biopharmaceutical product</li></li></ul><li>CLASSIFICATION OF BIOPHARMACEUTICALS<br />
  11. 11.
  13. 13. Group of proteins that </li></ul> causes blood cells to<br /> grow and mature. <br /><ul><li>e.g. Erythropoietin
  14. 14. Glycoprotein hormone that controls Erythropoiesis
  15. 15. Produced by the endothelial cells of kidney
  16. 16. Absence  Anemia</li></li></ul><li>CLASSIFICATION OF BIOPHARMACEUTICALS :<br /><ul><li>MONOCLONAL ANTIBODIES :
  17. 17. Produced by using Hybridoma Technology
  18. 18. Popularly known as “Magic bullets”
  19. 19. Used for the treatment of </li></ul> Rheumatoid Arthritis , cancers <br /><ul><li>Antibody produced by a single clone of cells</li></li></ul><li>CLASSIFICATION OF BIOPHARMACEUTICALS :<br /><ul><li>VACCINE :
  20. 20. Biological preparation that</li></ul> improves immunity to<br /> a particular disease <br /><ul><li>They can be prophylactic or</li></ul> therapeutic<br /><ul><li>e.g. HBV vaccine
  21. 21. It is a Subunit Vaccine composed of only surface proteins, produced in the yeast</li></li></ul><li>CLASSIFICATION OF BIOPHARMACEUTICALS :<br /><ul><li>THROMBOLYTIC AGENTS :
  22. 22. Protein involved in breakdown of blood clots
  23. 23. Anti- coagulants
  24. 24. e.g. Tissue Plasminogen Activator
  25. 25. Serine protease
  26. 26. Found on endothelial cells
  27. 27. Absence – Acute Myocardial Infarction</li></li></ul><li>CLASSIFICATION OF BIOPHARMACEUTICALS :<br /><ul><li>INTERFERON :
  28. 28. Cell signalling proteins produced by the cells</li></ul> of the immune system <br /> in response to the challenges such as viruses<br /> & cancer cells<br /><ul><li>e.g. IFN –a , IFN -b , IFN -g </li></li></ul><li>CLASSIFICATION OF BIOPHARMACEUTICALS :<br /><ul><li>BLOOD FACTORS :
  29. 29. Components of blood
  30. 30. e.g. Factor VIII
  31. 31. It is also known as Anti-hemophilic factor
  32. 32. Synthesized and released in the blood stream
  33. 33. Absence - Hemophilia </li></li></ul><li>CLASSIFICATION OF BIOPHARMACEUTICALS :<br /><ul><li>HORMONES :
  34. 34. Chemical substance that controls and regulates the activity of certain cells or organs.
  35. 35. E.g. Insulin
  36. 36. Produced in islets of </li></ul>langerhans in pancreas.<br /><ul><li>Lack of insulin - Diabetes mellitus</li></li></ul><li>INTERFERON<br />
  37. 37. INTERFERON<br /><ul><li>Interferons are proteins which are produced by the cells of the immune system - in response to challenges viruses and tumors.
  38. 38. They assist immune response by :</li></ul>Inhibiting viral replication<br />Activating the natural killer cells and macrophages<br />Increasing antigen presentation to lymphocytes<br />
  40. 40. Tissue infected by virus<br />Interferon molecules produced<br />It is released and diffused to the <br />surrounding cells<br />It binds to the receptor<br /> of the adjacent cells<br />Production of anti – viral protein <br />This protein blocks the<br /> viral replication<br />
  41. 41. COMMERCIAL PRODUCTION OF INTERFERON<br />WHY ???<br /><ul><li>Physiochemical characterization
  42. 42. Purification
  43. 43. Clinical Application </li></li></ul><li>COMMERCIAL PRODUCTION OF INTERFERON type II<br />Blood collected in acid citrate-dextrose solution <br />by venipuncture<br />Peripheral blood lymphocytes – isolated by FHGM <br /> Lymphocytes also obtained by Plasmapheresis<br /> Lymphocytes suspended to 106 cells per ml in RPMI medium<br />
  44. 44. SEA (Staphylococcal Enterotoxin A) interferon inducer added (0.1 μl per ml)<br />Mercaptoethanol added.<br />Fetal calf serum added (10 %)<br />Roller bottles were seeded with 300 ml cell suspension<br />Roller bottles – gassed (7 % O2, 10% CO2, 83 % N – 1 min)<br />
  45. 45. Suspension was rotated (8 rpm – 37 ⁰C , 4 days) <br />Centrifuged (2000 rpm , 4 ⁰C) and supernatant collected<br />Controlled core-glass beads were added to interferon supernatant.<br />Glass beads containing INF was collected and centrifuged .<br />Beads were washed with phosphate buffered saline.<br />
  46. 46. Ethylene glycol added to elute interferon<br />Removal of SEA inducer by Immunoabsorption<br />Gel filtration was done on ultrogel to isolate the specific interferon. Fractions (5 ml) collected <br />pH and temp. studies done to monitor heat stability and any residual antiviral activity.<br />
  48. 48. ADVANTAGES OF BIOPHARMACEUTICALS<br /><ul><li>Highly effective
  49. 49. Highly specific
  50. 50. Fewer side effects
  51. 51. They are not carcinogenic
  52. 52. Safe
  53. 53. Easy commercial production</li></li></ul><li>COMMERCIAL APPLICATIONS OF BIOPHARMACEUTICALS<br /><ul><li>Production of different biopharmaceutical products :
  54. 54. Epogen and EpoREL - Commercially produced erythropoietin hormone </li></ul> which is used against Anemia<br /><ul><li>Monoclonal Antibodies - Rituximab , Ceutximab - used against various lymphomas
  55. 55. Biopharmaceuticals produced by rDNA technology - Recombinant Vaccines e.g. Recombivax HB (hepatitis B viruses)</li></li></ul><li> CONCLUSION<br /><ul><li>Biopharmaceutical drugs account for 8% of total pharmaceutical market sales, and are the fastest growing part of the market.
  56. 56. Biopharma exports account for over 74 % of overall export from India in health industry.
  57. 57. Thus they may turn out to have the most profound influence on the future practice of molecular medicine.</li></li></ul><li>REFERENCES<br />Book of India Brand Equity Foundation<br />Medical Pharmacology – K. D. Tripathy<br />Immunology – Kuby (5th edition)<br />Biopharmaceutical - Wikipedia, the free encyclopedia.mht<br />Large-scale production and physicochemical characterization of human immune interferon.htm<br />biopharmaceuticals - Google Images.mht<br />Bioscience 2015 Vision.mht<br />Wiley InterScienceOnlineBook Summary.mht<br />interferon - drug class, medical uses, medication side effects, and drug interactions by MedicineNet_com.mht<br />
  58. 58. THANK YOU<br />