North South University

“A Pharmaceutical Product That Is Made With The Help

Of Biotechnology”
PHR325 : Pharmaceutical Biotechnology
Section - 4

Submitted by –
MD Istiaq Ul Alam Submitted to –
(2012433649) Dr. MD Reatul Karim
(Assistant Professor)

30th October, 2023

 Insulin – A Pharmaceutical Product That Is Made With The Help Of
Biotechnology

Introduction –

The pancreas, a vital organ nestled behind the stomach, plays a crucial role in maintaining our
body's metabolic equilibrium. It accomplishes this through the secretion of a vital hormone
known as insulin. This remarkable substance stands as the linchpin in the intricate mechanism
that regulates blood glucose levels, ensuring they remain within a narrow, life-sustaining range.

The annus mirabilis of 1921 heralded a monumental leap forward in the annals of medical
science. It was during this pivotal year that two pioneering scientists, Frederick Banting and
Charles Best, unraveled the secrets of insulin production. This landmark discovery not only
illuminated the path to a deeper understanding of metabolic disorders but also ignited a
revolution in the treatment of diabetes.

In its nascent stages, insulin was procured from the pancreases of animals, a method laden with
inherent challenges. The quest for a reliable supply, coupled with the pursuit of purity and
consistency, formed a formidable trifecta of obstacles. This early approach, while
groundbreaking in its own right, eventually gave way to more refined methods of insulin
production, allowing for greater precision and reliability in its therapeutic application.

Today, insulin remains a beacon of hope for millions around the world, offering a lifeline to those
whose bodies grapple with the intricate dance of glucose regulation. The legacy of Banting and
Best endures in every vial, reminding us of the indomitable spirit of inquiry and innovation that
continues to illuminate the path towards better health and well-being for all.

Recombinant DNA Technology and Insulin –

In the history of medical science, the study of human insulin represents a significant turning
point. Its introduction opened the door to a radical change in the way diabetes—a chronic illness
that affects millions of people globally—was managed. The release of ground-breaking research
on the use of recombinant DNA technology for the biocatalytic synthesis of human insulin in
[Govender,T., Naicker,T. (2023)]
1979 marked a significant turning point . This groundbreaking research not
only advanced the area but also established the framework for its regular incorporation into
industrial operations.
The pancreas contains specialized beta cells that produce insulin, which is essential to the
human body's delicately balanced control of blood glucose levels. The story of the development
and discovery of therapeutic insulin reads like an epic tale of industry and biomedical innovation
working together. Numerous people who struggle with diabetes have seen a significant
improvement in their quality of life as a result of this fruitful collaboration. This accomplishment
leaves a legacy that continues to demonstrate the limitless possibilities of science and
reinforces our ability as a society to develop solutions that have a beneficial effect on the lives of
people who suffer from chronic illnesses.

The Significance of Human Insulin –

The discovery of human insulin is considered a turning point in medical history since it changed
the way that diabetes is treated. Its introduction, made possible by recombinant DNA
technology, transformed patient care by providing an alternative to insulin obtained from animals
that is safer, purer, and more consistently dependable. This significant discovery has improved
the lives of millions of people with diabetes worldwide and serves as an example of how
[Burks D.J., White M.F.
biotechnological innovation has the power to completely transform healthcare.
(2001)]

Genetically Modified Organisms (GMOs) in Insulin Production –

The use of genetically modified organisms (GMOs), specifically modified strains of bacteria, is at
the center of this biotechnological revolution. These bacteria are carefully engineered by
scientists to effectively manufacture insulin. These bacteria that have undergone genetic
engineering function as living factories, producing insulin with remarkable accuracy. Strict safety
protocols and legal structures are in place to guarantee the proper and safe use of genetically
modified organisms (GMOs) in the manufacturing of pharmaceuticals, addressing issues with
public health and environmental effect. [Brogard, J. M., Blickle, J. F., & Paris-Bockel, D. (1985)]
Advantages of Biotechnological Insulin Production –

 Enhanced Purity and Potency: The biotechnology method produces extremely pure
insulin, guaranteeing constant potency and quality in every batch. This purity is
necessary for trustworthy and efficient diabetic care.
 Cost-Effectiveness: Biotechnology-based mass production drastically lowers
production costs. This ultimately results in cheaper insulin, increasing accessibility for
those who require it.
 Customization and Innovation: Thanks to biotechnology, researchers are able to
create insulins that are specifically suited to the demands of each patient. Ultra-rapid-
acting insulins are one example of this for accurate blood sugar regulation.
 Diminished Environmental Impact: The environmental impact of biotechnological
procedures is far lower than that of conventional methods that produce insulin through
animal rearing. This is in line with current initiatives to use sustainable manufacturing
methods for pharmaceuticals.

Challenges and Ethical Considerations –

The extensive use of biotechnological insulin manufacturing is not without difficulties, despite its
enormous potential. The use of genetically modified organisms (GMOs) in medications is one
major source of worry. Critics raise concerns about unanticipated outcomes and possible long-
term impacts. Regulatory bodies are vital in mitigating these apprehensions as they enforce
stringent protocols and supervision.

There are ethical problems as well, especially with regard to fair access to cutting-edge insulin
technologies. Ensuring that all patients with diabetes may benefit from biotechnological
developments is crucial, irrespective of their geographic or economic circumstances.

Recent Innovations in Insulin Biotechnology –

Recent advances in insulin therapy include ultra-rapid-acting insulin and ultra-long-acting basal
insulin therapies. The focus of basal insulin development is toward longer and flatter profiles of
action to reduce hypoglycemia and provide more flexibility with timing of dosing. The focus of
rapid-acting insulin (RAI) development is toward faster onset and offset of glucose-lowering
action. [Wilson, L. M., & Castle, J. R. (2020)]
Conclusion –

The combination of biotechnology and insulin synthesis has changed not only how people with
diabetes live their lives but also how modern medicine is practiced. The transition from insulin
derived from animals to human insulin manufactured by biotechnology marks a significant
breakthrough in medical science. Diabetic care has a bright future if continuous innovation and
fair access are prioritized.

References –

1) Govender, T., Naicker, T. Insulin as a catalyst to recombinant DNA technology. Nat

Catal 6, 454–455 (2023).
2) Burks D.J., White M.F. IRS proteins and beta-cell function. Diabetes. 2001;50(Suppl.
1):S140–S145. doi: 10.2337/diabetes.50.2007.S140.
3) Brogard, J. M., Blickle, J. F., & Paris-Bockel, D. (1985). Genetically engineered insulin:
five years of experience. Drugs under experimental and clinical research, 11(6), 397–
406.
4) Wilson, L. M., & Castle, J. R. (2020). Recent Advances in Insulin Therapy. Diabetes
technology & therapeutics, 22(12), 929–936.