For most of its existence, bioprocessing was an industry almost no one outside of it had ever heard of — the unseen manufacturing arm behind every biologic, doing its work several layers removed from public view. That changed, briefly and dramatically, during the COVID-19 pandemic. As the world raced to manufacture vaccines at a scale no biologic had ever required before, names like Thermo Fisher Scientific, FUJIFILM Diosynth Biotechnologies, and Cytiva — formerly GE Healthcare Life Sciences — suddenly entered the public conversation. These were not vaccine developers. They were the bioprocessing equipment manufacturers and contract manufacturers whose capacity, capital investment, and raw material supply chains had become the binding constraint on how quickly the world could actually produce enough vaccine to meet demand. For a brief moment, the industry that builds the bioreactors, supplies the cell culture media, and runs the manufacturing batches was the story.
That moment passed, and bioprocessing returned to relative obscurity. But the underlying reality it exposed never went away: this is a multibillion-dollar global industry, populated by equipment manufacturers, raw material suppliers, and contract manufacturing organizations, and it is the only reason any biologic — a monoclonal antibody, a vaccine, a cell or gene therapy — exists as a physical product a patient can actually receive. Understanding what this industry is, how it is structured, and how a biologics company actually gets a product manufactured is foundational knowledge for anyone stepping into a leadership role at a bioprocessing-dependent company, regardless of which functional background they come from.
What Is the Difference Between Bioprocessing and Biomanufacturing?
The two terms are often used interchangeably, and in casual industry conversation that interchangeability rarely causes confusion. Where a distinction is drawn, biomanufacturing typically refers to the broader manufacturing operation as a whole — the facility, the production strategy, the overall function responsible for turning a biological product into commercial or clinical supply. Bioprocessing more often refers to the specific technical unit operations within that manufacturing operation: cultivation, cell culture, separation, purification, and the other discrete process steps that physically transform raw biological material into a finished therapeutic. In practice, a biomanufacturing operation is built out of a sequence of bioprocessing steps, which is why the terms blend together so easily in everyday use.
Why Does an Industry This Large Go Largely Unnoticed?
The invisibility of bioprocessing is structural, not accidental. It sits in the middle of the biologics value chain, between two activities that naturally attract attention for very different reasons. Upstream, drug discovery and clinical development are inherently visible — they involve scientific breakthroughs, regulatory milestones, and patient outcomes, all of which generate coverage and conversation. Downstream, commercial distribution and patient access are visible because they are the point at which the product finally reaches the people who need it, often accompanied by pricing and access debates that draw public attention.
Manufacturing sits between these two visible bookends, doing work that is essential but fundamentally unglamorous: producing the same biologic, batch after batch, to exacting and tightly regulated specifications. It is industrial infrastructure, not scientific novelty or patient story, and industrial infrastructure rarely makes headlines regardless of how critical or how expensive it is to build and operate. The result is an industry that moves enormous capital, employs a highly specialized workforce, and determines whether a promising therapeutic ever reaches a patient at all — while remaining almost entirely unknown to anyone who hasn’t had a direct reason to learn about it.
Where Does Biomanufacturing Sit in the Biologics Value Chain?
A useful way to understand biomanufacturing’s position is to trace a biologic’s path from concept to patient. Discovery and preclinical research identify and validate a therapeutic candidate. Clinical development tests that candidate in patients across a series of regulated trial phases. Somewhere alongside clinical development — and well before commercial launch — a manufacturing strategy has to be established, because every dose used in a clinical trial, and every dose eventually sold commercially, has to be physically produced by someone, somewhere, under regulated conditions. Biomanufacturing is that production function. It does not end once a product reaches commercial approval; it continues for as long as the product is on the market, which for a successful biologic can mean decades of continuous, tightly controlled manufacturing.
What Is the Build-Versus-Buy Decision in Biomanufacturing?
Every biologics company faces a foundational manufacturing strategy decision, often well before it has a commercially approved product: whether to build and operate manufacturing capability internally, or to rely on external partners to manufacture on the company’s behalf. In practice, most companies land somewhere on a spectrum between these two extremes, which is why biomanufacturing strategy is frequently described as hybrid rather than purely one model or the other.
At one end of that spectrum, a company builds and staffs its own manufacturing facility, procuring the raw materials, custom media, equipment, and buffers it needs directly from suppliers, and running its own manufacturing batches in-house using its own technical staff. At the other end, a company contracts with a contract development and manufacturing organization, commonly referred to as a CDMO, which operates its own facility and runs manufacturing batches on the company’s behalf, using its own equipment, staff, and — often — its own supplier relationships for raw materials. Most biologics companies use some combination of these approaches across different stages of development or different products in their portfolio, rather than committing exclusively to one model company-wide.
What Factors Drive the In-House Versus Outsourced Decision?
The decision to manufacture in-house, outsource to a CDMO, or pursue some hybrid combination of the two is shaped by several interacting factors, and the right answer is rarely the same for every company or every stage of a product’s lifecycle.
Time and speed to clinic weigh heavily in early development. Building an in-house manufacturing facility from the ground up can take years and an enormous capital outlay, which makes it impractical for a company that needs manufacturing capacity quickly to support an upcoming clinical trial. A CDMO, by contrast, already has facilities, equipment, and trained staff in place, which can compress the time to first clinical batch significantly.
Flexibility matters differently depending on a company’s pipeline. A company with a single, well-defined product and a clear, well-funded path to commercial scale may eventually find in-house manufacturing more cost-effective at volume. A company with multiple early-stage candidates, uncertain about which will ultimately advance, often benefits from the flexibility a CDMO relationship provides — capacity can be scaled up, scaled down, or shifted between products without the company carrying the fixed cost of underutilized internal facilities.
Capital and resource availability are an obvious but decisive factor. Building internal manufacturing capacity requires not just the facility itself but specialized equipment, a trained technical workforce, and an ongoing quality and regulatory infrastructure to support it — a level of capital commitment that many earlier-stage or resource-constrained companies are simply not positioned to make.
Willingness and capability to manage third-party relationships also shapes the decision, and it is often underweighted relative to the more obvious factors above. Outsourcing to a CDMO does not eliminate manufacturing risk or oversight responsibility — it shifts the nature of the work from running manufacturing directly to managing a manufacturing partner closely, including technology transfer, quality oversight, and ongoing relationship management. Companies without the internal capability or appetite to manage external manufacturing relationships rigorously often underestimate how much oversight a CDMO relationship still requires, even though the company itself is not running the production line.
What Does the Supplier Ecosystem Behind Biomanufacturing Look Like?
Regardless of whether a company manufactures in-house or relies on a CDMO, both manufacturing models depend on the same underlying supplier ecosystem: companies that produce the custom cell culture media, raw materials, single-use equipment, and process buffers that any bioprocessing operation requires to function. This supplier layer sits one level further removed from the visible parts of the industry than manufacturing itself, which compounds the broader invisibility problem described earlier — most people who have never worked directly in bioprocessing have no occasion to learn that an entire specialized supplier industry exists purely to provision the raw materials and equipment that make biologics manufacturing possible in the first place.
Why Does Understanding This Industry Matter for a New Executive?
For an executive newly arriving at a bioprocessing-dependent company — whether stepping into a commercial, operational, or general management role — understanding this landscape is not optional background knowledge. Nearly every strategic decision the company makes eventually intersects with manufacturing strategy: how quickly a product can reach clinical trial, how much capital is required and when, how much control the company retains over its own supply chain, and how exposed the company is to a manufacturing partner’s capacity constraints or quality performance. A leader who understands the build-versus-buy spectrum, the factors that should drive that decision, and the supplier ecosystem underneath it all is positioned to ask the right questions of their manufacturing and supply chain teams — rather than discovering, only after a manufacturing disruption or capacity shortfall, how much of the company’s fate was riding on a function they never fully understood.