The document discusses the production of recombinant insulin, which addresses issues with traditional animal-derived insulin by offering a pure and consistent alternative. It details the historical context, production processes including gene isolation and purification, and highlights the advantages such as reduced allergy risk and scalability. Additionally, it notes the challenges in production, ethical concerns, and the significant impact of recombinant insulin on diabetes management.

1. XBT702 Recombinant DNA Technology
Production of recombinant- insulin
Submitted by
M.Baghyalakshmi (121011101411)
JS.Bala Bharathi(121011101412)

2. Introduction:
What is Insulin?
 Insulin is a hormone produced by the pancreas.
 It helps regulate blood glucose levels by promoting glucose
uptake into cells.
Why is Insulin Important?
 Lack or inefficiency of insulin leads to diabetes.

3. Need for recombinant insulin:
Earlier insulin was derived from pigs and cows.
Challenges included limited supply, impurities, and allergic reactions.
Recombinant insulin solved these issues.

4. Historical Background
Before Recombinant insulin:
 In 1922, animal insulin (from pancreas of pigs or cows) was first
used.
 However, there were problems like immune reactions and limited
supply.
Introduction of Recombinant Insulin:
 1978: First recombinant insulin developed by Genentech using E.
coli.
 1982: Approved for commercial use as "Humulin."

5. Key Steps in Production:
Gene Identification:
Insulin gene is isolated from human DNA.
Insertion into Vector:
Human insulin gene is inserted into a plasmid (vector).
Transformation into Host Cell:
The plasmid is introduced into a host cell, such as E. coli or yeast.
Expression and Purification:
Host cells produce proinsulin, which is later converted to active insulin.
Purification removes impurities, ensuring safety and efficacy.

6. Techniques Used
Recombinant DNA Technology:
 Combines human insulin gene with plasmid DNA for replication and
expression.
Fermentation Process:
 Large-scale culturing of genetically modified E. coli or yeast in
bioreactors.
Purification Steps:
 Methods like chromatography are used to extract and purify insulin.
Enzymatic Processing:
 Cleaves proinsulin into active insulin.

7. Advantages of Recombinant Insulin
High Purity and Consistency:
 Free from impurities seen in animal insulin.
Low Allergy Risk:
 Matches human insulin, reducing immune responses.
Large-scale Production:
 Efficient and scalable to meet global demand.
Cost-effective in the Long Run:
 Production costs decrease with advanced technologies

8. Challenges in Production
High Initial Costs:
 Setting up rDNA technology and bioreactors is expensive.
Complex Technology:
 Requires skilled personnel and advanced facilities.
Stringent Regulations:
 Requires approval from health authorities (e.g., FDA) to ensure safety.
Ethical Concerns:
 Use of genetically modified organisms (GMOs) raises debates

9. Applications in Medicine
Diabetes Management:
 Used for Type 1 diabetes (insulin-dependent) and advanced Type 2
diabetes.
Customized Formulations:
 Includes rapid-acting, long-acting, and combination insulins.
Improved Quality of Life:
 Enables better glucose control with fewer complications

10. Conclusion and References:
 Recombinant insulin has transformed diabetes care by providing a
safe and effective treatment.
 It is a landmark achievement of biotechnology.
References:
1.Kumar, A., et al. (2020). "Biotechnological Advances in Insulin
Production."
2.Smith, J. (2019). "The Role of Recombinant DNA in Modern Medicine."
3.FDA Website on Insulin Approvals.