What is repatha made from?

Are you tired of hearing about high cholesterol and not knowing what to do about it? Well, look no further than Repatha! This medication has revolutionized the way we treat high cholesterol. But what exactly is it made from? Let’s dive in!

Introduction

Repatha is a medication used to lower LDL (bad) cholesterol levels in the blood. It belongs to a class of drugs called PCSK9 inhibitors, which work by blocking a protein that prevents the liver from removing LDL from the bloodstream.

Plant-Based Origins

You might be surprised to learn that even though Repatha is available as an injectable medicine, its origins are actually plant-based! The active ingredient in Repatha, evolocumab, was first isolated from tobacco plants.

Biotechnology Production

But wait, how does one get medicine out of a plant that’s typically associated with smoking? Through biotechnology production methods such as recombinant DNA technology and genetic engineering. These techniques can take specific pieces of genes from different organisms and then create new combinations in order to produce proteins like evolocumab.

Development and Clinical Trials

Repatha was developed by Amgen Inc., a biotechnology company based in California. Since its inception, it has undergone extensive clinical trials involving thousands of patients worldwide before ultimately receiving approval for use by the U.S Food and Drug Administration (FDA) in 2015.

Phase I: Safety Testing

During this phase,scientists tested extremely low doses on human subjects and monitored their health closely for any negative side-effects or dangers arising

Phase II: Efficacy Testing

This stage saw considerably larger groups subjecting themselves higher dosages.The focus here was on efficacy; assessing whether there were signs of lowered cholestrol levels among participants at all / observing how long-term usage could prove beneficial or detrimental.

Phase III: Large-Scale Efficacy and Side-Effects Testing

This phase consisted of large-scale testing on various groups, such as those diagnosed with hypercholesterolemia, to establish the long-term effectiveness of Repatha.Useful data pertaining to rare side-effects also com out.

Manufacturing Processes

Now that we understand how evolocumab is produced through biotechnology methods let’s discuss how Repatha is actually made in a pharmaceutical manufacturing facility.

Fermentation

Production process starts from expunging products from bacteria using specially manufactured equipment by inducing fermentation

Purification ,Concentrating & Finishing Methods

The harvested fluids are sent through advanced purifying protocol and concentration before producing into the injectable forms:

  • Avails 140mg/ml and 420 mg/mL after solution formation.
  • During this final stage it gets arranged suitably for each injection or administering method.

Final Products

Repatha consists of many individual components working together towards one common goal – an effective treatment for high cholesterol levels:

  • The active ingredient, evolocumab, makes up 1% of each dose.
  • The water used to dissolve evolocumab comprises most (~80%)of the residual volume .It has undergone purification processes that meets required standards (for human consumption)and other tests performed including pH level check.

Conclusion:

While you might not think about where your medicine comes from when you pick it up at the pharmacy—you should be delighted now knowing just what goes into making Repatha! From plant-based origins to biotechnology production methods followed by extensive clinical trials.Its no wonder why this product is so costly but remember your health is priceless(LITERALLY). Each stage requires a comprehensive team effort made possible only with intense collaboration between researchers.Together, they have created an innovative medication available today thanks to their dogged work ethic.They are heroes behind the veil who deserve our gratitude, applause and recognition!

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