What Are Biologics and How Are They Used in the Pharmaceutical Industry?

Biologics are drugs produced using a living system, like microorganisms, plant cells, or animal cells. The particles used in biologics are made through complex processes and are at the center of a variety of products like vaccines, monoclonal antibodies, recombinant proteins, gene therapies, and beyond.

Biologics are reinventing the way we view the pharmaceutical landscape because they are innovative solutions that provide therapeutic benefits to patients with a wide range of diseases and conditions. Learn more about this fascinating technology and discover how it is being used to help provide relief to a variety of patients in our post.

The Origin of Biologics in Pharmaceuticals

The first use of biologics in medicine traces back to the late 19^th and early 20^th centuries. Emil von Behring was the first to make the discovery while working on a serum therapy for diphtheria. However, it was Paul Ehrlich’s work on the “magic bullet” that started the movement for the use of biologics in targeted drug delivery. Together, the work of von Behring and Ehrlich led to the development of vaccines that worked against infectious diseases, marking the earliest successes of biologics in medicine.

It is safe to say that a lot has evolved since the discovery of biologics in medicine, and regulation has played a key role. The use of biologics in medicine started to be regulated by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) in the early 2000s. These organizations set specific guidelines in place to ensure any produced drugs are safe and transparency is maintained for patients.

Regulating Biological Medicine

The FDA and EMA oversee the approval for regulation of biological products. The approval process is rigorous to help ensure the safety, efficacy, and quality of each product released to the public. For this to happen, each biological medicine goes through both clinical and preclinical testing. The clinical trials include three phases of testing.

Once a biological drug is approved for use on the market, agencies continue to monitor the safety of it through surveillance programs. Adverse and other side effects are reported and evaluated. Products will be taken off the market if serious safety concerns arise. Additionally, there are thorough investigations conducted specifically for the use of biologics in the pediatric and geriatric populations.

Lastly, there are strict quality control measures in place to ensure consistency throughout the manufacturing process. Biologicals must be manufactured in a GMP facility. Additionally, there must be a label on the drug that describes product information like dosing, administration, potential side effects, and contraindications. Together, these factors work together to keep patients safe while encouraging the evolution of treatment for appropriate populations.

Using Biologicals in Pharmaceuticals to Provide Therapeutic Benefits to Patients

Following their discoveries, von Behring and Ehrlich truly started a movement when they began using biologicals in pharmaceuticals. Since these two found success back in the early 19^th and 20^th centuries, a variety of other discoveries have been made.

Here are some other astonishing biologic discoveries that have shifted the way that patients are treated:

Recombinant DNA technology used the genetic engineering of bacteria to produce human proteins like the insulin growth hormone and revolutionized diabetes treatment
Monoclonal antibodies were discovered, opening up new opportunities to prevent organ transplant rejection
Growth hormones were developed to help children who had growth disorders
Cytokines were understood on a deeper level which resulted in therapeutic treatment for immune disorders like asthma, rheumatoid arthritis, Lupus, Cohn’s Disease, and more
Gene therapies like Kynriah can be used to treat certain types of cancer
mRNA can be used in vaccine technology, such as with the COVID-19 vaccine

Combining Biological Medicine with Sustained Release Technology

Since Oakwood Labs uses sustained-release technology, it would be amiss to not look at biologics for this form of therapy. Biologics can be modified to achieve specific release patterns that enable controlled and sustained drug delivery in patients. This leads to reduced dosing and better therapeutic benefits for patients who need it.

Here are the main methods that incorporate the use of biologicals with sustained-release technology:

Microspheres/nanoparticles – Biologics can be encapsulated within microspheres and nanoparticles that are made out of biocompatible materials. Then, these particles can be engineered to release the biologic over an extended period of time. The encapsulation is helpful for protecting the biologic from degradation and can be used to enhance stability.
Implants – Biologic medicine can be encapsulated within implantable devices like biodegradable scaffolds. As the scaffold breaks down, it will slowly release the biologic which is useful for localized and long-lasting treatments.
Hydrogels – Hydrogels are water-absorbing polymers that hold water and biologics. Gels can be designed to have sustained release qualities to maintain a consistent concentration of the therapeutic agent for extended periods of time.
Fusion proteins – Engineering fusion proteins is done by combining a biologic with a carrier protein. The carrier protein helps extend the half-life of the biologic which creates a sustained release effect.

Benefits of Incorporating Biologics into Medicine

Using biologics in medicine has proven its success in countless ways across the industry. Biologics can benefit each patient in different ways, and this depends on what they are being treated for.

Here are just a few of the properties that biologics possess and why they are trusted to form new treatments:

Targetable – Biologics can be targeted to reach specific molecules, cells, or even pathways, which encourages precise treatment while simultaneously reducing the risk of attacking healthy cells or tissues.
Diverse – Effective therapeutic outcomes can be achieved for a wider audience since biologics can be personalized with a patient’s unique genetic makeup in mind.
Innovative – Thanks to advancements in technology, biologics are used to treat diseases that were previously difficult to target with small-molecule drugs. Examples include autoimmune disorders, certain types of cancer, and rare genetic diseases.

Biologics in Pharmaceuticals vs. Small Molecule Drugs

From their composition to their manufacturing processes, there are a variety of ways that biologics differ from traditional small-molecule drugs.

Composition – Biologics are large, complex molecules that are derived from living organisms. They are produced using biotechnical processes. Small-molecule drugs are chemically synthesized with a smaller-sized molecule. They have a defined number of atoms.
Action course – Biologicals have highly specific mechanisms of action that allow them to target specific cells, proteins, and receptors. This makes them especially useful in precision medicine and targeted therapy treatments. However, small-molecule drugs have a tendency to interact with a wide range of molecules due to their small size and structure.
Stability – Since biologics are sensitive to environmental factors like temperature and pH, their stability and shelf life are often shorter than those of small-molecule drugs.

Contact Us Today for More Information

Biologicals are at the forefront of biomedical research. With time, we can expect them to offer effective treatments for a variety of medical illnesses and conditions that have formerly been difficult to treat.

If you have any questions about biological medicines or the future of their impact in the world of pharmaceuticals, be sure to reach out to our team.

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Mark Ilhan

Mark Ilhan joined Oakwood Labs in 2013. Over the last 7 years he has worked to establish and maintain relationships with a variety of global pharmaceutical clients. Primary activities include representing Oakwood at global conferences with the scientific team, creating drug development proposals, and strategic marketing. His expertise is in Business Development and Project Management. He received a Bachelor’s degree in Management and Finance from Case Western University, and an MBA from Cleveland State University.