BioProcess 101
Understanding bioprocessing and bioprocess engineers
What is bioprocessing and what makes it so important? “Bioprocessing is defined as any process that uses complete living cells or their components (e.g., bacteria, enzymes, chloroplasts) to obtain desired products. Bioprocessing is also key to several emerging industries and technologies, including the production of renewable biofuels such as ethanol and biodiesel, therapeutic stem cells, gene therapy vectors, and new vaccines. The Food and Drug Administration imposes stringent regulations on bioprocessing in the biotech industry; this highly regulated environment has an enormous impact on plant operations and product manufacture.” — International Quality and Productivity Center (IQPC) Glossary If this definition sounds a lot like cellular agriculture to you, you’re right. Cellular agriculture is a segment of bioprocessing that is “the production of agricultural products from cells,” as defined by New Harvest, the first nonprofit in the field.
Who are bioprocess engineers?
“Bioprocess engineer” from the historical/traditional bioprocessing industry perspective means an engineer who makes tools for or understands bioprocessing technologies including but not limited to piping, process flow diagrams (PFD), bioreactor design, bioprocess optimization software (occasionally), or anything else related to bioprocesses from in perspective of an engineering discipline or mindset. This individual is traditionally an engineer (often mechanical) that rarely understands life science techniques/workflows like pipetting, cell culture, making a working stock from a master stock, using a hood, sterile technique, etc. More specifically, in this definition of “bioprocess engineer,” this individual is usually a mechanical engineer who specializes on the “process” or equipment part of bioprocessing. If you ask this type of bioprocess engineer to tell you who knows how to execute those life science techniques, their response will usually be, “I don’t know — find a scientist” or if they’re well-integrated in modern bioprocessing technologies they’ll still say, “I don’t know — find a microbiologist.”
Comparatively, “bioprocessing” from the life sciences perspective usually consists of scale-up optimization for a range of bioreactors and organisms, known as expression vectors. These expression vectors are varied and popular ones include include Chinese hamster ovary (CHO) cells for mammalian protein production, insect cells such as SF9 cells, yeast, hybridoma cell lines, and E. coli, — all used in a variety of ways for the purpose of recombinant protein production, monoclonal antibody (MoClo) development, or AAVV production for synthetic biology (re: materials/food) or biotherapeutic applications. In 2020, bioprocessing industry professionals are just now starting to realize the disparity between the traditional Bioprocess Engineer (usually trained in engineering of bioproduction systems for microbial applications, most often biofuels) and people who understand how to do bioprocess scale-up from the life science perspective. Usually, the primary people who have the capability to fill in the gaps between the two are spread across industries like biofuels, industrial biotech, biologics development, synthetic biology or the government.
To make matters more confusing: both the engineering side of the house and the life science side have labeled these distinct areas, functions, capabilities and expertise as “bioprocess engineering.” The life sciences side has also traditionally called it “fermentation science,” and traditionally, experts in that field have been conditioned/educated by the markets to primarily identify and describe both perspectives in terms of microbial fermentation, algae, corn-to-fuel, exclusively. Unfortunately, an additional gap further exacerbates the problem that upstream scientists (often microbiologists/virologists/therapeutics developers, and others) often do not have experience in “bioprocess scale-up” beyond bench top or flask-to-10L range. This is where contract research organizations (CRO) or contract development organizations (CDO) come into play.
Essentially, CROs and CDOs are companies where individuals from life sciences work together with engineers to co-create a unique body of knowledge and collective organizational expertise in scale-up bioprocessing. The caveat is each CRO/CDO is usually only specialized to their specific niche in the market, often based on their facility or bioreactor capabilities/ scales and expression vector-specific scale-up knowledge base. The other individuals who can demonstrate life science-view bioprocess expertise are fermentation scientists/fermentation engineers, but usually they focus on microbial fermentation — which has limited application in modern mammalian/stem cell applications.
To summarize the problem in 2020, individuals who have the knowledge or capability to scale up non-microbial (non-Yeast/E. coli) expression vectors for real-world applications are very rare, and even more rare is the individual who understands how to best scale-up a variety expression vectors from a bioprocessing (life science interpretation) perspective using the correct bioprocessing tools (from the engineering perspective).
So when it comes to making new foods, it’s often hard to find bioprocess specialists who have the breadth in expertise to span the whole production process. New foods require new cell types (pig, fish, et cetera) for cell-based meat production (also known as cultivated meat production), or steep cost reduction for fermentation technologies. For fermentation technologies used by Impossible Foods and Perfect Day, the challenge of reducing costs enough to make food product production viable requires crossover skills as well.
