Pharmaceutical Companies A Manufacturer Of Synthetic Insulin

Table of Contents

Question:

Prepare a detailed report on a specific product currently being marketed by a major pharmaceutical or biopharmaceutical company.

Answer:

Histories of the Product

To meet the growing demand for healthcare, pharmaceutical companies began large-scale production of synthetic insulin.

Types of insulin are also determined by how quickly it becomes functional (Klubo–Gwiezdzinska and co., 2015).

There are three types of insulin: short-acting, intermediate-acting, and long acting.

The history of type 1 diabetes is that before scientists discovered insulin, people with the disease had to die.

In 1921, Friendrick Banting, a Canadian scientist, was able purify insulin.

Further experiments revealed a form of insulin that could be released in lower amounts in the blood.

The addition of protamine, a fish protein that the human body slowly breaks down, was what led to this discovery.

Although insulin production methods have undergone many modifications, they are still the same.

Initial insulin was extracted from the pancreass of calves or pigs, followed by purification.

These insulins, which are identical in function to humans and animals, work well together.

Some people might complain about allergies, which led to the 1980 development of biotechnological industrial production.

The chemical structure of insulin was determined, which allowed it to be located in the chromosome.

Initial experiments involved the splicing the insulin gene from mice into a bacteria that enabled insulin synthesis.

The scientists were able use genetic engineering techniques to synthesize human insulin protein in the 1980s.

In 1982, Eli Lily Corporation produced the first human insulin, which was later accepted as a drug product.

The insulin was free from animal contaminants, it was produced on a large scale, and there were no concerns about the possibility of human-animal transmission.

Most pharmaceutical companies use recombinant DNA technology for insulin production (Wang and al., 2014).

Biology underpinning the condition being treated

Insulin is an important hormone that regulates blood sugar levels.

Insulin is responsible for transporting sugar from the blood to cells for metabolism (Higgs & Fernandez 2014).

The beta cells of your pancreas produce this hormone.

Sometimes, these cells release insulin in very small quantities while other times they release an insulin surge.

After food is digested in the stomach, it is converted to molecules that can easily be absorbed by the cells.

These carbohydrates are those that are converted to sugars by the cells for use in various body processes, such as glycolysis.

After eating, if blood glucose levels are high, pancreatic cells produce insulin in proportion.

The glucose in the blood starts to enter the cells through the plasma membrane by binding the insulin transporter to the cell membrane.

The cells become starved if there is not enough insulin production from the pancreatic cells (Lipska & Montori, 2015).

The liver forms ketones from continued starvation, which can cause coma and other complications.

Diabetes can also be caused by a lack of insulin production. Type 1 and type 2 are two possible types.

Type 1 diabetes patients receive insulin injections three times per day.

Diabetes type 2 patients may produce some insulin from their pancreas, but they might need to inject more often (e.g. once or twice daily).

Production Process

Method 1

E. coli bacteria is the main raw material for insulin production, though yeast can be used in some cases.

The protein or gene that produces insulin is a major concern for manufacturers.

This can be obtained using a machine that sequences amino acids to create DNA fragments (Heinemann & Hompesch 2014).

Large tanks are required for bacteria growth as well as carbon and nutrients that are food sources.

After isolating the insulin gene, production of insulin requires several steps using recombinant DNA technology.

The insulin gene codes the insulin protein. As the cell is carrying its metabolism, the insulin gene can be translated to make proteins.

The manufacturers alter the biological processes of bacteria in this instance (Kumar & Partha, 2017).

The insulin gene is then transmitted to the bacteria, and metabolism continues.

In its structure, the insulin gene contains two subunits: the A and B chains.

The A chain contains 21 amino acids, while the B chain contains 30 amino acids.

The proinsulin must be co-joined with A and B subunits before it can become active. However, it does not have the signal sequence.

The A and B subunits of proinsulin are grown separately in pharmaceutical companies to prevent each enzyme from being manufactured.

These minigenes can be used in two ways.

The minigene A forms chain A, and the minigeneB gives chain B.

The resulting chains can be inserted into the vector (cloning vectors), which is then used by competent bacteria.

The plasmid can be inserted into the and cultured, followed by transfection.

To aid in the stickiness of the recombinants to the bacteria, DNA ligase can be added.

The bacteria that makes insulin is then fermented at high temperatures in large tanks.

By mitotic processes, the bacteria reproduces and forms millions of copies with insulin genes in each one (Mimi et. al. 2015).

The cells are then opened to allow DNA to be extracted.

By treating DNA with cyanogens bromide, the methionine can be broken down so that the insulin chains can be separated.

In the oxidation-reduction step, the insulin chains A andB are joined using disulfide bonding.

Method 2

This method uses a precursor called proinsulin to make insulin.

The process is identical to method 1, except that the machine is used for the amino acid sequences.

The proinsulin is fermented in large tanks, where the A and the B insulin chains are spliced with an enzyme. After purification (Sandow et. al. 2015).

The ingredients are then mixed with insulin to prevent bacteria from entering and maintain a neutral pH.

This is a crucial step in the manufacturing of long-acting insulin.

Purification

Manufacturers then purify the insulin chains using chromatography, reverse HPLC or other size separation methods.

Each batch of insulin is then tested to ensure that no E.coli proteins are mixed with insulin (Moein and al., 2014).

The marker protein is used to determine the presence of E.coli. After the bacteria has been removed, the insulin remains.

Quality control is crucial when insulin protein manufacturing takes place.

If there are any impurities in insulin, you can use other purification methods such as gel filtering, X-ray crystallography and amino acid sequencing.

To ensure proper sealing, insulin vials are tested for their integrity (Thomas and al., 2014).

The National Institute of Health recommends that insulin manufacturing be done using safety measures.

Commercial production of insulin requires large-scale equipment that will face many challenges as it scales up.

Based on the manufacturing process parameters, the cost and dependence are determined.

It is crucial to reduce unnecessary costs and minimize the environmental impact.

An investment in a pharmaceutical manufacturing plant could be as high as $150 million.

During purification of insulin particles, the unit production cost could reach $70/g.

This manufacturing plant could yield satisfactory returns of around 70% if we assume that insulin is $100 per gram.

A 40mg vial of insulin may cost $25, which indicates that it is financially feasible to sell at $100/g.

Pharmaceutical manufacturing companies have negative environmental effects, especially in the way they dispose of wastes (Heldin and al., 2014).

These wastes raise concerns about the impact of pharmaceutical waste on the health of communities.

There needs to be sustainable ways to manage the wastes as more people with diabetes are being diagnosed and others are still living with the condition (Ortigosa, et al. 2015).

Both insulin infusion pumps as well as tubing-free infusion sets can have an impact on the environment.

Also, it is important to consider the impact of the manufacturing process on the environment, especially those containing biological chemicals.

These wastewaters can be extremely toxic, so manufacturing companies need to ensure they have proper detoxification before releasing them to the environment.

Also, they should have proper disposal systems for plastic and paper. This is especially important after the diabetic patient has used the vials.

Refer to

Biosimilar Insulins Basic Considerations.

Journal of diabetes science & technology, 8(1), pages 6-13.

Heldin, E.; Gronlund S.; Shanagar J.; Hallgren E.; Eriksson K. Eriksson K., Xavier M., Tunes H. and Vilela L. (2014)

A step in intermediate chromatography for insulin purification.

A High Throughput Process Development approach that is based on selectivity parameters.

Journal of Chromatography B 973, pp.126–132.

Higgs M. and Fernandez R. (2014).

PW367 A systematic review of the effect of insulin therapy algorithms upon blood glucose levels post-operatively following cardiac surgery.

Global Heart, 9(1), P.e334.

Klubo-Gwiezdzinska (J.), Cochran E., Semple R.K. Brown R.J., and Gorden P.

Continued effectiveness of combination therapy for type B insulin resistance due to autoantibodies to Insulin Receptor.

Clinical Issues in Type 1 & Type 2 Diabetes (pp.

Endocrine Society.

Partha, M.A.N.P.

Kinetic and structural Differentiation of Trypsin From Different Origins.

BioPharm International, 31(1).

Lipska, K.J.

ACP Journal Club.

In type 1 diabetes, intensive insulin treatment for 6.5 years reduced the risk of death at 27 years when compared to usual care.

Annals, 162(10) p.JC12.

Mimi, N. Belkacemi H. Sadoun T., Sapin A., and Maincent P. (2015).

How composition and manufacturing parameters influence insulin release from polymeric microparticles.

Journal of Drug Delivery Science and Technology 30, pp. 458-466.

Moein, M.M.M., Javanbakht M., and Akbari-adergani B., 2014.

For rapid and easy analysis of insulin in plasma or pharmaceutical formulations, molecule-imprinted polymer cartridges are used.

Merck Sharp & Dohme Corp. (2015).

Purifying insulin by cation exchange and reverse-phase chromatography in the presence a organic modifier and at elevated temperatures

Sandow, J. Landgraf, W. Becker, R. and Seipke G. (2015).

Recombinant human insulin equivalents and their role in therapy.

Eur Endocrinol 11(1): pp.10-6.

Thomas, A., Schanzer W. and Thevis M., 2014.

The determination of insulin in humans and their analogues using liquid chromatography coupled with ion mobility mass spectrumrometry (LC?IM??MS).

Drug testing and analysis 6 (12), pp.1125-1132.

Remedi, M.S.

Thermogenesis of insulin therafter pancreatic b cells dedifferentiation in diabetes

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