With the development of increasingly advanced biotherapies and other critical products, bioprocessing—a key part of manufacturing and bringing these therapies and products to people—is becoming more important than ever. From vaccines and cell therapies to food and biofuels, bioprocessing provides many benefits to society—though it can be challenging and costly.
However, there are several new technologies and techniques aiming to solve these issues and help make bioprocessing more efficient and less expensive. We take a look at some of the fundamentals of bioprocessing as well as an overview of recent trends, particularly related to the pharmaceutical and medical industries.
What is bioprocessing?
Bioprocessing is the creation of useful products through the use of a living thing—usually cells or cell components, viruses, or an entire organism. End products can be anything from biofuels produced from algae, or antibiotics created from mold, such as penicillin. Beer produced from yeast is another example of bioprocessing. Given the diversity of applications for bioprocessing and the complexity of the steps involved, this field requires proficiency in many areas of science including chemistry, biochemistry, biology, microbiology, and chemical engineering.
Key steps in bioprocessing
Bioprocessing involves two main segments: Upstream bioprocessing and downstream bioprocessing. The upstream part involves the early stages of bioprocessing—identifying the identification of the organism to be produced, optimizing the conditions it requires to grow, and then growing and collecting this organism. With biopharmaceuticals specifically, the upstream process includes isolating the cell line to be produced, growing those cells at the scale required for the final product, and then harvesting those cells.
Downstream bioprocesses include the later stages of production and involve purifying the cells or other organisms collected at the end of the upstream stage to create a final product that meets stringent safety and quality standards.
Bioprocess engineering is another key aspect of bioprocessing that involves optimizing the environment or system in which the organism resides to ensure it can produce the needed product at the scale and quality required, but at the lowest possible cost. Bioprocess engineers are therefore critical to any industry making use of biological products or biomaterials. For a more in-depth look at this field, Ritesh Kumar, PhD, provides an overview of bioprocess engineering, what’s required for a career in this field, and key trends shaping industries that rely on this discipline.
Key challenges in bioprocessing and recent solutions
Though the COVID-19 pandemic has brought more attention to bioprocessing’s role in the development of vaccines, it also presented challenges to the medical and pharmaceutical industries. Companies in these fields faced supply chain disruptions, shortages of key materials, and had to cope with new COVID-19 safety measures that limited the number of people able to work in their facilities.
However, positives also came out of the COVID-19 situation with companies sharing resources, building better relationships with their suppliers, and adopting new technologies faster than they would have prior to the pandemic.
In general, the biggest challenges in bioprocessing, especially when it comes to developing and producing biotherapeutics and vaccines, are time and cost. Companies are always searching for ways to shorten the length of time it takes from discovering a drug to manufacturing and shipping that drug. According to Erik Vaessen of FUJIFILM Irvine Scientific, bettering cell culture media formulations is another key challenge in cell therapy production in particular. Supporting technologies, finding the right partner to ensure quality, and the use of artificial intelligence will be key solutions to this issue, Vaessen says.
Adding to the conversation on cell therapies, Evan Zynda and Aditi Singh, of Thermo Fisher Scientific, point out that in some personalized cell therapies for cancer, the challenging workflows required to produce such treatments are a barrier to their wider use. Allogenic approaches to such therapies could help conquer these challenges with cell culture media playing a key role in maintaining cell quality when producing these treatments on a large scale.
Another difficult, time-intensive challenge in the biopharma industry is finding high-quality cell lines. Automating the process of isolating single cells using microfluidics is one solution that could save companies a great deal of time and money. In addition to microfluidics, automation in single-use bioprocessing technologies and their wider use throughout the entire bioprocessing workflow will likely be a trend going forward due to the requirements of personalized medicine.
While wise implementation of such technologies is certain to help make bioprocessing more efficient and cost effective, strong partnerships and a collaborative spirit between companies, their clients, and others in the industry will be just as important to ensure that those depending on bioprocessing can manage both current challenges and those that arise in the future.