The Basics of Bioprocess Engineering (hero image)

The Basics of Bioprocess Engineering

What is it, what do bioprocess engineers do, and key trends in the field

Ritesh Kumar, PhD

Ritesh Kumar is a scientist offering medical and bioscience consulting, writing, editing, and peer review services. He holds a PhD degree in molecular biology and has 11 years of experience...

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What is bioprocess engineering?

Engineering innovations in biotechnology industries generating bioproducts are called bioprocess engineering. This field is proficiency in biological and chemical engineering. It includes the direction, design, and process required to turn innovations in life science into practical products that can meet the needs of society. Bioprocess professionals have numerous goals; one of the most common is the production of biopharmaceuticals. For the economic development of new products, bioprocess engineering is very important. Bioprocess engineering has played a major role in fermentation industries, in addition to the manufacturing of antibiotics, ethanol, amino acids, organic acids, and other specific products. In 1928, Alexander Fleming showed that Staphylococcus were inhibited by colonies of Penicillium Notatum and identified it as due to a secreted substance—penicillin. To scale up the amount of penicillin, a combination of applied microbiology and fermentation engineering was used. This is a perfect example of how bioprocess engineering helps in the large-scale development of a pharmaceutical product.

What do bioprocess engineers typically do and what education do they require?

A bioprocess engineer generally optimizes the system using biological materials to manufacture a variety of biological products. Bioprocess engineers can work in many fields like agriculture research and development, food processing companies, biotechnology firms, waste management sectors, fuel, and pharmaceutical industries. These professionals are often tasked with improving efficiency, work safety, and product quality by utilizing their skills and knowledge in biology, chemistry, math, and engineering. They must regularly update their skills, as these industries face constant change, with new emerging technologies and regulations.

Other common activities of bioprocess engineers include an awareness of mechanical and chemical engineering principles to improve the research and production of new products. Knowledge in microbiology, math, computer science, and communication skills play vital roles in performing detailed calculations and demonstrations of new design efficacy. Examples of bioprocessing projects include: 

  • Data analysis of different biochemicals and monitoring their effects on viruses and bacteria. 
  • Process evaluation in manufacturing or food processing plants by optimizing existing techniques to increase yields. 
  • Investigate additives, preservatives, ingredients, and other nutrients to determine if they could enhance the shelf-life or quality of certain foods. 
  • Ensure food safety by analyzing methods of production to meet federal quality standards.

Education required to do bioprocess engineering

Those interested in a career in bioprocess engineering will require at least a bachelor's degree in biology or chemistry. In addition, most bioprocess engineers go on to pursue a graduate degree. You also need experience in a laboratory setting. A doctoral or master’s degree allows a person to become a senior researcher, who is free to design research projects and can supervise junior engineers in their daily work.

Key industries that use bioprocess engineering

Bioprocess technology and its engineers are essential in every industry that relies on biomaterials or biological products. Bioprocess technology is the backbone of the biotechnology industry, translating scientific discoveries to industrial products. The pharmaceutical industry commonly employs bioprocess engineers to develop and organize manufacturing processes for novel drugs, pharmaceuticals, supplements like antibiotics, and vaccines, while the medical industry involves bioprocess development for biopharmaceuticals to generate a safe, effective, and stable product.

Key challenges and solutions in bioprocess engineering 

In this advanced, technical world, the growing biopharmaceutical industry is facing a number of technical and non-technical challenges. Some of the technical challenges are expensive processes, novel technologies, and sophisticated instrumentation and their control. To develop methods for rapid identification of new biochemical properties, immunogenicity, and efficacy of protein-based pharmaceuticals also requires improving the processes used for existing products. Expanding the range of biopharmaceuticals that can be produced with prokaryotic cells or non-mammalian expression systems, which allow the use of less expensive media and have lower capital requirements than current technologies, cost-effective, easily scaled up technologies should be produced for high-resolution protein purification that has minimal waste-disposal requirements. 

Some of the non-technical challenges include government approval processes and effective communication between industry and regulators. These challenges impact the bioprocess engineer’s ability to contribute timely solutions to the US biopharmaceutical industry. To address these issues, it is necessary to reduce response times after submissions, and ensure resolution of generic efficacy safety or related manufacturing issues quickly. Further ways to solve these challenges include more training sessions to qualify engineering students and enhancing funding programs for the development of intensive technologies for large volume, low-value added pharmaceuticals and manufacturing facilities.

Current trends in bioprocess engineering and future outlook

Recently, several trends have been enhancing biopharmaceutical manufacturing and bioprocessing—many of these have positive outcomes. During the ongoing pandemic crisis, many of the current trends have been enhanced, with some of these effects leading to permanent change in bioprocessing and vaccines manufacturing.

Surveys and review reports from last year (Rader, A and Langer, E.S. 2020), suggest that these ongoing trends are likely to continue through 2021. Future planning in the bioprocessing sector can provide benefits to public health strategies. The key trends include:

  • Expanded pharma facilities and biological product possibilities, but often with smaller markets
  • Wider range of manufacturers producing biosimilars and biogenerics
  • Improved efficiency of bioprocessing, with yields continuing to increase
  • Magnifying events in high-tech expression systems and other genetic advances
  • Automation, checking, and process control
  • Wide use of bioprocess modeling, related to focusing on downscaling

According to a recent article by MIT chemical engineering professor Charles L. Cooney, PhD, to stay competitive, especially during the COVID-19 situation, pharmaceutical industries are taking actions such as:

  • Improving the quality of supply chains for raw material. Lockdowns caused by the pandemic uncovered problems in supplier networks, difficulty in acquiring raw material, APIs, and other equipment necessary to keep operations running. To keep production going, companies are tending to increase the inventory of rare products. Personal relationships proved essential across supply chains and manufacturers when supplies were limited, as this enables sharing not only information, but also relevant equipment and supplies.
  • More flexible design manufacturing processes. Since discontinuation was so common in many supply chains, pharmaceutical companies innovated to manage shortfalls, re-examined their procedures, and found better ways to meet their needs without impacting quality standards.
  • Changing traditional bioprocessing techniques and embracing new bioprocessing modalities like cell-free systems, continuous manufacturing systems, and genome editing. Use of these new bioprocessing modalities has been accelerated by production of COVID-19 vaccines, therapeutics, and promising data from different clinical trials.
  • Prioritize health safety measures. Due to the pandemic, biopharmaceutical manufacturing shifted tactics to decrease the number of employees on the floor at a time and comply with COVID-19 guidelines and procedures regarding appropriate PPE.
  • Automation through machine learning (ML) and artificial intelligence. Application of these techniques allows remote control of equipment, without the need for human intervention and alleviating risk for employees. Digital twins or representations can deliver as models to optimize or check manufacturing procedures. Leading companies in pharma have already set up other business operation ML—like robotic process automation—that can improve workflows.

The overall global economy of the pharmaceutical industry remains stable despite the uncertainty of 2020. But manufacturers must be ready in every situation, evaluating opportunities and learning how to proceed with new technologies to evolve with respect to the marketplace.