Humulin, Human Insulin

Humulin is synthetic human insulin prepared by using Recombinant DNA Technology. It is one of the best example of Genetically Modified Microorganisms.

1. 1 GMO: Humulin History, Methods And Risks MS. GAURAVI RAUT M.SC. BIOTECHNOLOGY PATKAR-VARDE COLLEGE

2. Introduction Humulin History Structure of human insulin How do they make insulin from recombinant DNA Types of H umulin Risks Advantages of Humulin Over Insulin Reference INDEX 2

3. Genetically modified microorganisms: Alteration of an organism’s gene for practical purpose Performed by modifying an organism’s own DNA or introducing new DNA to perform desired functions GMOs have emerged as one of the mainstays of biomedical research Recombinant DNA technology: uses genetic engineering to introduce genes into microorganisms and other cells and help to produce metabolites of commercial or medical importants such as insulin, vitamin, amino acids or enzymes Most reason to prefer microorganisms: Grow rapidly Easy to cultivate Environmentally friendly than conventional chemical synthetic method Pharmaceutical products: Recombinant hepatitis B vaccine (GM Baker’s Yeast) Injectable insulin (GM Escherichia coli ) 3 INTRODUCTION

4. Synthetic human insulin used for treating diabetes Recombinant DNA technology Prior to its development, diabetics used insulin isolated from pig and cow pancreases Recombinant pharmaceuticals 4 HUMULIN

5. In 1982, Lilly's Humulin: first genetically engineered drug approved by the US FDA FDA approval: five months after application was made by Eli Lilly and Company of Indianapolis, Ind . Normally, such approval takes 20 to 30 months First drug produced by genetic engineering techniques to gain the FDA approval for human use Efforts : four years ago, after scientists at the City of Hope National Medical Center in Duarte, Calif., and Genentech Inc. in South San Francisco first succeeded in producing it in the laboratory Inserting human genes responsible for insulin production into E. Coli bacteria, thus stimulating the bacteria to synthesize insulin Humulin had proved to be safe and effective in FDA clinical trials involving more than 400 patients Today, available in both a vial and a disposable prefilled pen: helps in choosing a convenient way of taking humulin HISTORY 5

6. Hormone produced by β-cells of islets of Langerhans of pancreas Peptide hormone produced by pancreas and is a central regulator of carbohydrates and fat metabolism in the body It controls blood sugar lever and when there is less secretion of insulin, it results in diabetes (high blood sugar level ) Insulin consists of a 21-amino acid A chain and a 30-amino acid B chain , linked by two disulfide bonds. It can be produced either by generating the chains separately and chemically combining them or by creating a single-chain precursor, human proinsulin and cleaving out a 35-amino acid connecting peptide For manufacturing the drug, the proinsulin route is favored because it requires a single fermentation and isolation step 6 STRUCTURE OF HUMAN INSULIN

7. 7 HOW DO THEY MAKE INSULIN FROM RECOMBINANT DNA?

8. Basic Steps Involved In Humulin Production

9. 9 Hakura et al(1977) chemically synthesize DNA sequence of insulin for two chains A and B and separately inserted into two PBR322 plasmid vector

10. 11 WHAT TYPES OF HUMULINS ARE AVAILABLE ? For the treatment of high blood sugar (glucose) levels, 3 types of Humulin can help to manage diabetes Each type varies in onset, peak time and duration Short-acting insulin It can cover insulin needs for meals eaten within 30 minutes NPH (Neutral Protamine Hagedorn) insulin Intermediate acting insulin Slower to act and lasts longer than regular human insulin Short-and intermediate-acting insulins combined to cover insulin needs after meals, throughout the day, and at night Available in a number of different ratios of mixing For example, Humulin M3: mix of 30% short acting & 70 % intermediate acting Humulin M5: 50 % of both short & intermediate acting Humulin R Humulin N Premixed Humulin

11. 12 Hypoglycemia Hypokalemia Edema Lipodystrophy Weight gain Immunogenicity Hypoglycemia Sweating Dizziness Hunger Anxiety RISKS

12. Earlier insulin required for diabetes was extracted from pancreas of slaughtered cattle, pigs or salmon. The process was quite tedious and difficult and yields of insulin would be low. This extracted insulin in some patients, developed allergy or other side effects due to foreign protein. Due to disadvantages of animal insulin and advantages of humulin, humulin is regarded superior to animal insulin. Humulin is considered better than animal insulin because: Absorbed more rapidly and show its effectiveness in short duration Causes fewer allergic and autoimmune reactions as compared to animal insulin Less expensive than animal insulin 13 ADVANTAGES OF HUMULIN OVER INSULIN

13. www.onlinebiologynotes.com www.biospectrumindia.com www.humulin.com 14 REFERENCE

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