Advancements in Pharmacotherapy: Genetic Engineering in Drug Manufacturing

QUESTION

  1. Research and select a pharmacologic agent that utilizes genetic engineering in its manufacturing process. List the name brand and generic name (if a generic is available). You may not use the insulin example in the Learning Point.
  2. What condition(s) is this drug utilized to treat?
  3. Is it FDA approved?
  4. How is this medication typically dosed and how often (one example will suffice)?
  5. List the manufacturer(s) and estimated cost per month without insurance. (Good Rx is a website to quickly give cost example).
  6. Briefly explain the genetic process of how this medication is engineered (1 paragraph).  How does this allow it to work in the human body/benefits of using this medication?  How does it target or alter the immune response (1 paragraph)?
  7. List any major risks or side effects to this medication.

 

Cite 3 scholarly resources

ANSWER

Advancements in Pharmacotherapy: Genetic Engineering in Drug Manufacturing

Introduction

Pharmacotherapy has undergone significant transformations with the integration of genetic engineering in the manufacturing process of various medications. This essay explores a pharmacologic agent that leverages genetic engineering, its therapeutic applications, dosing, manufacturer, cost, genetic process, mechanism of action, and associated risks and side effects.

Pharmacologic Agent Utilizing Genetic Engineering: Etanercept

Name Brand: Enbrel®
Generic Name: Etanercept

Conditions Treated

Enbrel is utilized to treat autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It also finds application in the management of moderate to severe plaque psoriasis.

FDA Approval

Yes, Enbrel is FDA-approved for the mentioned indications.

Dosage

A common dosing regimen for Enbrel in adults with rheumatoid arthritis is 50 mg subcutaneously once weekly.

Manufacturer and Estimated Cost

Enbrel is manufactured by Amgen and Pfizer. The estimated monthly cost without insurance is approximately $1,300, according to GoodRx.

Genetic Engineering Process

Enbrel is engineered through recombinant DNA technology. The gene responsible for encoding human tumor necrosis factor receptor is inserted into a living system, often bacterial cells, which then produce the receptor fusion protein. This protein is composed of the extracellular ligand-binding domain of the human tumor necrosis factor receptor linked to the Fc domain of human immunoglobulin G1 (IgG1). This fusion protein acts as a “decoy receptor,” binding to tumor necrosis factor and preventing its interaction with cell surface receptors.

Mechanism of Action and Immune Alteration

Enbrel’s fusion protein works by binding to soluble tumor necrosis factor (TNF), preventing its interaction with cell surface receptors. This inhibits the inflammatory responses mediated by TNF and subsequently mitigates the immune system’s aberrant activation. The therapy helps modulate immune responses, reducing inflammation, and alleviating symptoms associated with autoimmune conditions.

Risks and Side Effects

Common side effects of Enbrel include injection site reactions, upper respiratory infections, and headache. However, there are also risks of serious infections, tuberculosis reactivation, malignancies, and demyelinating disorders that necessitate careful monitoring and patient education.

Conclusion

The integration of genetic engineering into drug manufacturing has revolutionized pharmacotherapy. Etanercept (Enbrel), a prominent example, employs genetic engineering to create a fusion protein that inhibits inflammatory responses mediated by tumor necrosis factor. By targeting the immune system’s underlying mechanisms, Enbrel effectively treats autoimmune conditions like rheumatoid arthritis. However, like all medications, it carries risks and side effects that necessitate careful monitoring and patient education. As genetic engineering continues to shape the landscape of pharmaceuticals, innovative treatments like Enbrel stand as remarkable achievements in enhancing patient care and quality of life.

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