Issue #7: September 22, 2024
Come along with Our Bioanalyst
on the Front Lines of Medicine: Discover the Power of Bioanalysis
What’s Inside This Issue?
- Concepts and Terminology: Discover concepts and terminology introduced in the featured article.
- Featured Article: Join Ruby Cheung as she introduces us to the fascinating world of bioanalysis.
- About the Author: Read about Ruby Cheung’s journey as she pursued a career in bioanalysis.
- Hands-On Activities: Have fun exploring basic tools and techniques used in bioanalysis.
- Bioanalysis for Environmental Equity and Sustainability: Discover how bioanalysis can help build a healthier, more equitable, and sustainable world.
- Setting the Stage for Your Future: Explore a bioanalysis pathway.
- Glossary: Recap key concepts and terminology from the featured article.
1. Concepts and Terminology
- Bioanalysis: Scientists who do this work are responsible for tracking everything a drug does in the body: the amount of drug in a body, the fate of the drug, and the drug’s effect on the body. A person doing this work may be called a bioanalyst, clinical laboratory scientist, clinical pharmacologist, or medical laboratory scientist.
- FDA: Food and Drug Administration. A regulatory agency in the US responsible for protecting and advancing public health by ensuring that the medicines are safe and efficacious (effective).
- EMA: European Medicines Agency. The European Union’s version of the FDA.
2. Featured Article
Bioanalysis: The Science Behind Your Medicine
Ruby Cheung
Imagine this: You’re feeling under the weather, so you take some medicine. How do you know the medicine you’re taking is safe and effective for your particular ailment? The answer lies in a cool field of science called bioanalysis.
Bioanalytical scientists are the detectives of the drug development world, meticulously tracking a drug’s journey through the body. They employ precise analytical techniques to measure drug concentrations in blood, urine, and other biological samples. By analyzing this data, they can determine the drug’s absorption rate, distribution throughout the body, how it is metabolized by the liver and other organs, and how it is eventually eliminated from the system. This crucial information helps clinical pharmacologists, medical scientists who study how drugs work in the human body, determine the appropriate dosage, identify potential side effects, and ensure the drug’s safety and efficacy before it reaches patients.
Image Credit: National Cancer Institute
Why is this important? Bioanalysts develop the methods to figure out how much of a drug is needed to do its job without causing harm. By studying how the body reacts to different doses, bioanalysts help determine the safest and most effective way to use a medicine. Whether it’s treating the common cold or fighting a serious disease like cancer, bioanalysts are at the heart of the process.
The drug development process involves an exhaustive, multi-stage journey to bring new drugs to the market. First scientists must discover a potential new drug targeting a specific disease. The drug is tested in the lab and animals during preclinical research to ensure safety. Next, it enters clinical trials, where it is tested on human patients. After gathering all the safety and efficacy data, it is submitted to regulatory agencies like the FDA for approval. After the drug is approved and in the markets, there is strict monitoring to ensure safety. Bioanalysis plays a key role, particularly in the preclinical and clinical phases.
Image Credit: Ruby Cheung, created in Biorender.com
Making a new drug is no easy walk in the park. In fact, it’s full of twists and turns, starting in the lab. There, scientists hunt for molecules that might have the power to treat a disease. From thousands of potential molecules, they narrow these down to a few potential candidates. After being put through the wringer with rigorous testing in test tubes and petri dishes, the lead candidate moves forward.
Petri Dishes and Test Tubes in a Stand.
Once a molecule shows promise, it moves to the next stage: preclinical research which involves testing in animals. This phase is crucial for understanding how the drug behaves in a living organism. This is where bioanalysts really step up their game, tracking the drug’s journey through the body. They measure how it moves, where it moves to, how it’s processed, and how the body reacts to it. By analyzing the animal data, bioanalysts try to find the safest and most effective dose — hopefully one that can be translated to humans.
If that drug indeed proves to be safe and effective in animal studies, it moves onto the next phase of human clinical trials. This is where things get even more exciting! Bioanalysts use advanced techniques (see the “How do they do it” section below) to monitor how the drug is absorbed, distributed, metabolized, and eliminated in humans (often referred to as ADME). Additionally, they measure the drug’s effects on the body and how it interacts with other medications.
Safety First, Then Efficacy—with the help of experts
The number one goal in drug development is safety — bioanalysts, along with pharmacologists and toxicologists, work tirelessly to ensure that the drug doesn’t harm the patients. Pharmacologists focus on how the drug interacts with the body and how they produce their effects, while toxicologists study the potential harmful effects of drugs to ensure they are safe.
Bioanalysts play a key role by measuring the drug levels in the body, tracking the body’s immune response to the drug — which it may identify as a foreign substance or intruder — and looking for clues in other organs of the body that indicate the drug is working. Meanwhile, toxicologists check for dangerous side effects, and pharmacologists figure out how the drug can work best. Together, this team of experts helps create a balance between safety and efficacy.
Once safety is confirmed, the next goal is to figure out how well the drug works—what’s the best dose? Are the cells, proteins, or other molecules (disease markers) returning to healthier levels? Bioanalysts look for these clues to confirm that the drug is doing its job.
Throughout the entire drug development process, bioanalysts and their teams must follow strict regulations and guidelines, such as those set by the regulatory agencies like the Food and Drug Administration (FDA) and European Medicines Agency (EMA).
How do they do it?
Bioanalysts have a toolbox of super-cool techniques to investigate drugs. Here are two of the most common ones:
Immunoassays:
Imagine having millions of tiny, Y-shaped proteins that can specifically recognize and bind to particular molecular structures, much like a lock and key. These are antibodies, the immune system’s defense mechanisms. Bioanalysts can engineer custom antibodies that bind exclusively to the analyte (substance of interest), which in this case is the drug molecule. To detect this binding, a detectable label is attached to either the antibody or the analyte. This label, often an enzyme, radioactive isotope, or fluorescent dye, emits a signal that can be measured. By quantifying the signal, scientists can precisely determine the analyte concentration in the target substance.
Image Credit: Technology Networks
For example, in an enzyme-linked immunosorbent assay (ELISA), an enzyme is attached to the antibody. When the antibody binds to the analyte, the enzyme catalyzes a reaction (makes the reaction happen more quickly) so that it produces a color change. By measuring the intensity of this color change, researchers can determine the concentration of the analyte in the sample.
Chromatographic Magic:
Imagine a bag of colorful candies. If you wanted to sort them by color, you’d have to carefully separate each one. Chromatography is a similar process, but instead of candies, it’s used to separate a mixture of different substances.
A mixture is a combination of two or more substances that are not chemically combined. In one type of chromatography, a long, thin tube is filled with a special packing material, such as silica gel or alumina. This material acts as a filter, interacting with the substances in the mixture. Think of it as a maze that each substance must navigate. Different substances will move through the maze at different speeds based on their size, shape, and polarity. Polarity is the quality of a molecule, which can be measured, that tells us how much the electric charge is separated and distributed over the molecule. A highly-polar molecule will move faster in a liquid solvent than a low- or non-polar molecule. By collecting the separated substances at the end of the tube, scientists can identify and measure the drug molecule and any byproducts formed in the body.
Image Credit: Andra Mihali
Bioanalysis may seem complex, but it’s a crucial step in the development of safe and effective medicines. It’s like putting together a giant jigsaw puzzle, with each piece of information from bioanalysis contributing to the bigger picture. The next time you take a medication, remember the fascinating science behind it, from the initial discovery to the meticulous analysis that ensures its safety for you.
3. About the Author
Hi there! My name is Ruby Cheung, and I work in the Bioanalytical Sciences department in a biotechnology company in the Bay Area, CA. I’ve known Paul Jr. since he was a little baby — we are family friends from way back. Our families have been close for years, and I have so many fond memories of us gathering for holidays like Thanksgiving, where we’d share stories, play games, and enjoy each others’ company. I have cherished memories of watching Paul Jr. grow up, and his legacy as a fellow Cal Golden Bear continues to make me proud.
After high school, I pursued a double major at University of California, Berkeley – Cal – and double majored in Molecular and Cell Biology and Music. After college I entered the workforce in the Pharmacology department, which sparked my interest in exploring other areas of biotech. This led me to pursue a Master’s in Biotechnology Enterprise at Johns Hopkins University, where I learned about the many departments involved in building a biotech company.
Through this experience, I realized my passion for working in the later stages of drug development. I was fortunate and had the opportunity to pivot my career into Bioanalytical Science, where I’ve been ever since—and loving every minute!
4. Hands-on Activities
In immunoassays, pH indicators are essential as a tool because they help maintain optimal conditions for enzyme activity and allow researchers to monitor reaction progress and identify potential issues. The pH scale ranges from 0 to 14, where the pH measure of neutral 7 in the middle of the range equates to that of pure water. Lower numbers mean the substance is acid-like (‘acidic’), and higher numbers signify it’s base-like (‘basic’ or ‘alkaline’). Physical contact with liquids found at the extreme low and high ends of the scale can burn our bodies.
Creating a Homemade pH Indicator: This experiment works in the safe middle-range of the pH scale, exploring a little above and below pH = 7. For this, you’ll need things from your kitchen: part of a red cabbage, a saucepan big enough to cook it, a strainer, two smaller containers like drinking glasses to hold the cooled cabbage cooking water, vinegar, and some powdered baking soda.
Image Credit: Sik Lee Dennig,
created in ideogram
- Make the pH indicator:
- Shred the red cabbage and place it in a saucepan.
- Add a small amount of water and bring to a boil.
- Let it simmer for a few minutes until the water turns purple.
- Strain the liquid into a container and let it cool down.
- Test the pH indicator:
- Divide the purple liquid into two containers.
- Add a small amount of vinegar to one container.
- Add a small amount of baking soda to the other container.
- Observe the color changes.
- Expected Results:
- Vinegar (acidic) will turn the purple liquid pink or red.
- Baking soda (basic) will turn the purple liquid green or blue.
- Explanation:
- Red cabbage contains a natural pigment called anthocyanin, which changes color depending on the pH of the solution.
- Acids cause anthocyanin to turn red, while bases cause it to turn blue or green.
Chromatography is a scientific technique used to separate mixtures into their individual components.
You can try a simple version of chromatography at home. All you need is a coffee filter, water-based markers, and water. If you don’t have water-based markers, you can try using washable markers, highlighters, food coloring, or watercolor paint as substitutes.- Prepare your coffee filter: Draw a thick line with a water-based marker near the bottom of the coffee filter, about an inch from the edge. You can use one color or multiple colors.
Image Credit: Buggy and Buddy: Chromatography Flowers
- Set up your experiment: Fill a clear glass with about an inch of water.
Image Credit: Buggy and Buddy: Chromatography Flowers
- Watch the magic happen: Overlap and fold the filter into a cone shape to fit the cup, as shown. Carefully place the bottom of the coffee filter into the water, making sure the marker line doesn’t touch the water. As the water rises up the coffee filter, it will carry the ink with it. You’ll notice that the colors in the marker start to separate!
(order of increasing time: top left → right → lower left → lower right)
Image Credit: Buggy and Buddy: Chromatography Flowers
Why does this happen? The marker’s ink is a mixture. The different colors in the marker travel at different speeds through the coffee filter paper. This causes them to separate, revealing the individual colors that make up the original color.
This simple experiment is a fun way to learn about chromatography and how scientists separate complex mixtures.
5. Setting the Stage for Your Future: A Bioanalysis Pathway
Setting the Stage for Your Future: A Bioanalysis Pathway
If you’re intrigued by the idea of being a real-life problem solver, investigating the unseen world, and making a difference, bioanalysis might be your calling.
Focus on These High School Courses
To build a strong foundation for a career in bioanalysis, make sure to focus on these core subjects:
- Biology: Learn about living organisms and their processes.
- Chemistry: Understand the building blocks of matter and how substances interact.
- Math: Develop strong analytical and problem-solving skills essential for data analysis.
- Physics: This is a bit optional in your early education, but it will help you gain insights into the physical world. Those insights are relevant to many bioanalytical techniques. For example, learning about how light interacts with lenses (refraction, magnification) helps students understand how microscopes work. More sophisticated analytical machines are designed based on principles of physics. All of these tools are essential helpers in bioanalysis for observing cells and tissues.
Hands-On Learning
While classroom learning is important, practical experience can be even more enlightening.
- Science fairs and competitions: Showcase your scientific curiosity and problem-solving skills.
- Volunteer at local hospitals or research labs: Gain exposure to real-world scientific environments.
Building Your Network
Connecting with professionals in the field can provide invaluable guidance:
- Shadowing opportunities: Spend time with bioanalysts to understand their daily work.
- Mentorship programs: Seek guidance from experienced professionals.
- Science clubs and organizations: Join groups that share your interests.
Remember, a career in bioanalysis is a journey. Start building your foundation now by exploring your interests, taking challenging courses, and seeking out opportunities to learn and grow.
College Majors to Consider for a career in bioanalysis:
- Biochemistry: Provides a strong foundation in the chemistry of biological processes.
- Molecular Biology: While biology offers a broad understanding of living organisms and their systems, molecular biology zooms into the activities inside of cells and between cells, concentrating on the molecules responsible for those activities.
- Chemistry: Essential for understanding chemical principles and laboratory techniques.
- Pharmacology: Focuses on the study of drugs and their effects on the body.
Potential Career Paths:
- Bioanalytical Chemist: These scientists develop and validate methods to analyze biological samples, often working in pharmaceutical or biotechnology companies.
- Clinical Research Associate: Involved in clinical trials, collecting and analyzing biological samples to assess drug safety and efficacy.
- Environmental Scientist: Applies bioanalytical techniques to assess environmental pollution and its impact on human health.
- Quality Assurance Specialist: Ensures that the scientific experiments are conducted in accordance to the standards set by the regulatory agencies such as the FDA or EMA.
6. Bioanalysis: A Catalyst for Equity and Sustainability
Bioanalysis is a powerful tool at the forefront of building a healthier, more equitable, and sustainable world. By meticulously examining biological samples and the environment, scientists can uncover hidden threats to human health and planetary well-being. This knowledge is essential for addressing pressing challenges, from ensuring access to clean water to mitigating climate change.
For instance, bioanalysis played a pivotal role in exposing the Flint water crisis, where elevated lead levels were found in the blood of residents, particularly children. This data, obtained through blood lead testing, galvanized efforts to replace the contaminated water infrastructure, highlighting the tool’s capacity to drive environmental justice and public health improvements.
Source & Image Credit: Physics.org
Beyond human health, bioanalysis is vital for environmental sustainability. By analyzing soil, water, and air samples, scientists can assess the impact of human activities on ecosystems. This includes monitoring pollution levels in aquatic environments, detecting harmful algal blooms, and tracking the spread of invasive species.
A particularly concerning issue is the prevalence of microplastics, tiny plastic particles that have infiltrated our environment. Microplastics are super small pieces of plastic, even smaller than a grain of rice! They come from bigger plastic things that break down over time, like water bottles or shopping bags. You might also find them in products like face wash or toothpaste. These tiny pieces are a big problem because they don’t disappear. They can stay in our oceans, rivers, and soil for hundreds of years. Animals can eat them by mistake, and these plastics can even find their way into our food!
Through its ability to provide detailed information about our environment and its impact on human health, bioanalysis is a cornerstone of modern problem-solving.
Image Credit: PLASTIC ATLAS | Appenzeller/Hecher/Sack, CC BY 4.0
7. Glossary
- Algal: Relating to algae, a group of simple aquatic organisms that use photosynthesis but are not exactly plants. They can range in size from the microscopic to much larger.
- Antibodies: Proteins produced by the immune system to fight off infections. They are exceptionally small, typically 10 nanometers (10 billionths of a meter).
- Bioanalysis: Scientists who do this work are responsible for tracking everything a drug does in the body: the amount of drug in a body, the fate of the drug, and the drug’s effect on the body. A person doing this work may be called a bioanalyst, clinical laboratory scientist, clinical pharmacologist, or medical laboratory scientist.
- Clinical: The stage of drug development that involves testing in humans.
- Efficacy: The ability of a drug or treatment to produce the desired effect.
- EMA: European Medicines Agency. The European Union’s version of the FDA.
- FDA: Food and Drug Administration. A regulatory agency in the US responsible for protecting and advancing public health by ensuring that the medicines are safe and efficacious.
- Metabolized: The process by which the body breaks down substances, such as drugs or food, so that they can be used by the body.
- Pre-clinical: The stage of drug development that occurs before testing in humans. It typically involves testing in animals.
- Proteins: Large, complex molecules made up of amino acids that perform various functions in the body.
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