With something as important as our health, it is difficult to stress how crucial the process of developing and testing biopharmaceutical drugs is. Since they’re used by people across the nation and potentially across the world, it requires a thorough process to make sure that distribution is safe and efficient.
Biopharmaceuticals use various treatments for people with diabetes, cancer, cardiovascular disease, and many other health problems. As science and technology continue to improve, you’ll find that biopharmaceuticals will be part of that growth. Before long, people from all over the world will reap the benefits of these drugs.
This is how biopharmaceutical drugs are developed and tested.
What Are Biopharmaceutical Drugs?
Biopharmaceuticals are medical drugs get made using biotechnology. They’re made of proteins and nucleic acids used to prevent, treat, or relieve disease. Most biopharmaceuticals come from proteins found in nature but some consist of recombinant proteins which are genes manipulated by scientists.
The history of biopharmaceuticals begins with using plants and then progressed, creating the Salvarsan treatment kit for syphilis in 1909. Nowadays, there is an impressive amount of work done in the biopharmaceutical sector.
How Are Biopharmaceuticals Developed and Tested?
Every drug has to go through the process of development and testing. These are often long and detailed since they’re for public consumption. Being informed about the steps can give you a better sense of what you or a loved one will be putting into their body.
Discovery and Development
When there’s a new disease or new insight into an existing disease, researchers will begin to design a product to stop or reverse the effects of the disease. Pharma companies spend a lot of money on research and development.
Many companies, like Roivant Sciences, are at the forefront of drug development.
During the discovery and development phase, researchers create many molecular compound tests and new technologies. These help target specific areas within the body. They can also manipulate genetic material.
In this process, thousands of compounds might become candidates for development but only a few make it to the next round. Once they find a favorable compound, the experiments begin. The purpose of the experiments is to gather information on the compound.
Some of the things researchers are looking for are:
- The compounds potential benefits
- How it affects different groups of people
- It’s effectiveness compared to other drugs
- If injection or mouth is the best way to give the drug
- The way it’s absorbed and metabolized
Once all the information is gathered, it can move to the next step.
Before the drug gets tested on people, researchers have to test its toxicity. That’s the potential of how much harm it can cause once inside the body. There are two types of preclinical research: In vitro and Vito.
There are laws that require researchers to practice exemplary lab practices for preclinical studies. These tests analyze the bioactivity, safety, and how efficient a formulated drug product is. It’s an important step to the success of the drug. Usually, the drug is animal tested.
The tests that done during preclinical research should support the clinical research that comes next.
While preclinical trials may help gather information and answer important questions regarding a drug’s safety, the most efficient way to test is by doing human trials. Clinical research is the study, or trials, done in people.
As researchers go into the clinical period, there are different clinical research phases and specific regulations from the FDA which includes professionals visiting the testing site and what the selection criteria are for who is part of the human trial.
Phase 0 consists of a small group of people. Researchers use a tiny dose of medication to ensure it isn’t harmful to humans whatsoever before upping the dosage. If the medication acts unexpectedly, additional research is done.
For phase 1, around 20-80 healthy people are put on medication and researchers spend several months looking at the effects. The goal for phase 1 is to see what the highest dose of the medication is that humans can take without problematic side effects.
It’s difficult to predict exactly how medication will affect a variety of people so phase 1 can answer more questions about safety and best dosage in detail.
Phase 2 uses around 100 participants who are living with the condition that the medication is meant to treat. Then, similar to Phase 1, the participants are studied throughout several months to see if any side effects arise. While this is a larger study than the other phases, it still doesn’t give a complete answer about the overall safety of the medication.
Phase 3 usually takes several years to complete. It involves around 3,000 participants and they all have the condition meant to be treated. The goal of this phase is to prove that the medication is at least as safe and effective as other similar medications.
Phase 4 is the final phase. After the FDA approves the medication, thousands of participants are studied for several years. This is where researchers get the most information about the drug’s overall safety and effectiveness.
FDA Drug Review
Once a drug developer has evidence from the early tests and all of the trials that the drug is safe and effective, the company can start the application to market the drug. Since this is going out to so many people, the FDA review team does a detailed review of the application then decides to approve or deny it.
Drug development can take up to 15 years with just the first three phases, there are very high standards for submitting to the FDA.
Post Market Drug Safety Monitoring
Once the medicine is on the market, there is plenty of monitoring that follows. The FDA checks for any complaints and if there are any side effects or problems with the drug. There are also routine manufacturing inspections.
If there are any issues with the medication, it can quickly be pulled from the shelves.
The Importance of Biopharmaceuticals
The impressive change in medicine and technology is evident in biopharmaceuticals. Although a large aspect of everyone’s health, many people still don’t understand the process of development and testing.
Understanding how the medical field works is an important step to knowing what’s going in your body.
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