What Is Pharmaceutical Engineering?

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A pharmaceutical engineer tests a compound.

The use of pharmaceuticals can be traced to the 1500s, when the first list of drugs and their preparations was created in Germany. Since then, pharmaceuticals have become a keystone of medical care. They are a staple of today’s health care system, used to prevent and treat diseases and to restore and modify organic functions.

Pharmaceuticals come in a wide range of categories. Analgesics, for instance, relieve pain, from common headaches to more severe conditions like third-degree burns. Antivirals treat viral infections, such as the flu. Antibacterial drugs treat infections like tetanus.

For every medical condition, a pharmaceutical likely has been engineered to treat the condition itself or its symptoms. However, creating effective pharmaceuticals isn’t a simple or short process. Developing new clinical drugs to treat specific ailments is the work of pharmaceutical engineering, which has helped shape modern medicine and move patient care forward.

Through the advanced education and hard work of pharmaceutical engineers, efficient, effective, and safe over-the-counter and prescription medications are available to those who need them.

An Overview of Pharmaceutical Engineering

Pharmaceutical engineering involves the research, development, creation, and manufacturing of medicinal drugs. The engineering process starts by identifying a specific condition or ailment and researching the effects of past and current drugs used to treat it. Engineers often seek the expertise of physicians during this process. This research reveals critical information regarding the chemical stability, side effects, and overall safety of a medication.

After the research phase, new pharmaceuticals are developed by synthesizing chemical compounds in a laboratory. Pharmaceutical engineers who work in laboratory environments adhere to strict safety and quality protocols to ensure the end product is of the highest quality.

After development comes testing. During this phase of pharmaceutical engineering, new drugs are thoroughly tested for their effectiveness, safety, side effects, and chemical reactions. The end goal of the testing process is to confirm that the new drug works as intended and to prepare it for review by the Food and Drug Administration (FDA).

Once the new drug is reviewed and approved by the FDA, it can be manufactured and distributed to the public. The pharmaceutical engineering team will create a final version of the new drug, clearly identifying its unique qualities and what distinguishes it from other drugs on the market. The engineering team will also collaborate with physicians and medical researchers to establish a network of accountability and expertise for the drug.

What Does a Pharmaceutical Engineer Do?

Pharmaceutical engineers are directly involved in the research, development, creation, and manufacturing of new pharmaceuticals. Most pharmaceutical engineers work in state-of-the-art facilities and often perform the following specific job duties:

  • Conceptualizing and designing products
  • Synthesizing and testing compounds
  • Setting safety and quality protocols
  • Measuring potential side effects and stability issues
  • Manufacturing products
  • Labeling products and ensuring they comply with regulations
  • Packaging products to optimize their distribution

Good Manufacturing Practice (GMP) sets the standard for how pharmaceutical engineers should perform their jobs to help minimize the risks involved with pharmaceutical production. Originally adopted by the World Health Organization in the 1960s and now enforced by the FDA, GMP ensures that products meet quality standards and are consistently produced. It covers every aspect of production, including materials, facilities, equipment, training, and even engineers’ personal hygiene while working.

The detailed procedures of GMP are strictly adhered to by every pharmaceutical engineer working in the field, which is why the pharmaceutical industry in general is so highly regarded for its competence and consistency.

The Future of Pharmaceutical Engineering

Although the future of pharmaceutical engineering looks promising, the field is not without challenges. Labor shortages and supply chain issues pose the most serious threats to the industry. The biggest problems with the supply chain system for the pharmaceutical industry are related to obtaining active pharmaceutical ingredients (APIs). APIs are the primary components of drugs, and roughly 80% of them come from India, China, the European Union, and a few other countries.

U.S. dependence on foreign APIs was made evident when India imposed an export ban on active ingredients during the COVID-19 pandemic, the Harvard Business Review reports. Fires, earthquakes, and other natural disasters at key factories also sometimes occur, cutting off API supplies.

In response to supply chain issues, the Biden administration is pushing to create a domestic stockpile of pharmaceuticals to decrease reliance on foreign supplies. Manufacturing drugs domestically and improving the supply chain by leveraging private sector relationships are also being considered by the administration’s Supply Chain Disruption Task Force.

A number of key innovations in pharmaceutical engineering show promise, such as 3D-printed drugs. Hospitals and pharmacies could have the technology to produce 3D-printed tablets within the next decade or so, The Medical Futurist reports. Digital pills with embedded electronic circuits are another novel development. Rather than using a smartphone app to log when a medication was taken, a digital pill would send a signal to an external patch.

COVID-19 pressured researchers to find new ways of conducting clinical trials, which is why virtual in silico trials have gained significant traction. In silico trials allow for the testing of new drugs on virtual patients rather than real ones, which significantly streamlines the pharmaceutical engineering process, in addition to improving safety.

Be a Positive Influence on Patient Health

Pharmaceuticals are key to treating patients and maintaining a healthy population. Pharmaceutical engineering makes it possible for Americans to visit their local pharmacy and get the medications they need. It’s also how new drugs are created to combat novel medical threats and diseases.

The best way to become a pharmaceutical engineer is by investing in a degree program that will instill the knowledge and develop the skills needed to enter the field. The University of California, Riverside’s online Master of Science in Engineering program and its Bioengineering concentration includes courses such as Cellular and Molecular Engineering, Engineering Analysis of Physiological Systems, and Biotransport Phenomena that can prepare students to succeed in this crucial field.

Start on the path to a career in pharmaceutical engineering with the University of California, Riverside.

 

Recommended Reading:

Biomedical Engineering: Salary, Careers, and Education Requirements

Bioengineering vs Environmental Engineering: How They Differ

What’s the Difference Between Bioengineering vs Biomedical Engineering?

 

Sources:

Britannica, Pharmaceutical

European Pharmaceutical Review, “Key Challenges for Bio/Pharmaceutical Manufacturing 2022”

Harvard Business Review, “The U.S. Needs to Reimagine Its Pharma Supply Chain”

Indeed, “How to Become a Pharmaceutical Engineer in 5 Simple Steps”

International Society for Pharmaceutical Engineering, “Quality Risk Management: Ensuring Shared Responsibility Across Key Stakeholders”

The Medical Futurist, “Future of Pharma”

The Medical Futurist, “The 10 Trends Shaping the Future of Pharma”

Pink Sheet, “Why 2020 Saw the Steady Rise of In Silico Trials”

SL Controls, “A Day in the Life of a Pharmaceutical Engineer

U.S. Food & Drug Administration, Facts About the Current Good Manufacturing Practices (CGMPs)

U.S. Food & Drug Administration, General Drug Categories

World Health Organization, Good Manufacturing Practices