The Critical Choice: Single-Use vs Multi-Use in Pharmaceutical Manufacturing
How one technology decision shapes your entire facility's future
The pharmaceutical manufacturing world stands at a crossroads. Every day, companies face a decision that will define their operations for the next two decades: should they build their facilities around single-use disposable systems or traditional multi-use stainless steel equipment? This choice, seemingly technical on the surface, ripples through every aspect of a manufacturing operation, from the size of cleanrooms to the final cost per dose delivered to patients.
As personalised medicines emerge from research labs and pandemic response capabilities become strategic necessities, the manufacturing technologies of yesterday may not serve the needs of tomorrow. Yet the substantial investments required mean that today's decisions must anticipate an uncertain future.
The Product Dictates the Path
The journey towards the right technology choice begins with understanding what you're making. Not all pharmaceutical products are created equal, and each therapeutic category brings its own manufacturing personality.
Monoclonal antibodies represent the established middle ground. These biological workhorses have predictable production patterns and well-understood processes. During early clinical development, single-use systems offer an attractive proposition: faster setup, reduced validation timelines, and lower upfront costs. However, as these products mature and demand grows, the economics begin to shift. When annual production requirements climb beyond 10,000 litres, the recurring costs of disposable bags, filters, and tubing can exceed the operating costs of a well-designed stainless steel facility.
Gene and cell therapies tell a completely different story. These cutting-edge treatments often involve processes that are still being optimised as they move through clinical trials. Manufacturing protocols change frequently, contamination risks are elevated, and batch sizes remain relatively small. For these products, single-use technology isn't just convenient, it's often essential. The ability to quickly reconfigure production lines, eliminate cross-contamination risks, and avoid lengthy cleaning validations between different cell lines makes disposable systems nearly irreplaceable in this space.
Vaccine manufacturing occupies unique territory, with requirements that can shift dramatically based on circumstances. Traditional endemic vaccines might benefit from the cost efficiencies of multi-use systems, but the COVID-19 pandemic demonstrated the value of manufacturing agility. Companies that could rapidly deploy single-use systems found themselves better positioned to respond to urgent global health needs.
The Facility Design Cascade
The technology choice creates a cascade of consequences that flow through every aspect of facility design. These decisions, once implemented, are extremely difficult and expensive to reverse.
Single-use systems offer a fundamentally different relationship with space and infrastructure. Where a traditional facility might require extensive networks of permanent piping for Clean-in-Place (CIP) systems, steam distribution, and Water for Injection (WFI), single-use facilities can operate with remarkably minimal fixed infrastructure. This modularity translates into real advantages: faster construction timelines, easier facility modifications, and the ability to adapt existing buildings that might not accommodate traditional bioprocessing infrastructure.
The cleanroom implications are equally significant. The closed-system nature of single-use processing can enable lower cleanroom classifications, potentially allowing Grade C environments where Grade B might otherwise be required. This difference translates into substantially lower HVAC requirements, reduced energy consumption, and simplified facility operations.
However, this flexibility comes with trade-offs. Multi-use systems, whilst requiring more complex infrastructure, offer greater independence from supply chains. A facility built around stainless steel bioreactors isn't dependent on the timely delivery of specialised bags and filters, many of which have extended lead times and limited supplier bases.
The Economics Tell Two Stories
The financial analysis reveals a classic tale of two cost structures, each optimised for different scenarios.
Single-use systems typically require lower initial capital investment, often $2-5 million compared to $10-25 million for equivalent multi-use capacity. However, the ongoing operational costs tell a different story. Annual consumables costs can range from $500,000 to $2 million, depending on production volume and complexity.
Multi-use systems demand substantial upfront investment but can achieve remarkably low per-unit costs at high production volumes. The break-even point typically occurs somewhere between 10,000 and 20,000 litres of annual production.
The regulatory economics add another layer of complexity. Multi-use systems require extensive validation of cleaning procedures and ongoing monitoring programmes. Single-use systems may reduce cleaning validation requirements but introduce different challenges through the need to qualify each consumable component and conduct extractables and leachables studies.
The Environmental Equation
The sustainability implications present perhaps the most complex trade-offs in the entire decision matrix. Single-use systems generate substantial solid waste streams, primarily contaminated plastics requiring specialised disposal methods.
Yet comprehensive lifecycle analyses consistently reveal surprising results. Despite the plastic waste, single-use systems often demonstrate lower overall environmental footprints. The dramatic reduction in water consumption (no cleaning cycles), eliminated chemical cleaning agents, and lower energy requirements often outweigh the solid waste burden.
Multi-use systems, whilst generating minimal solid waste during operation, require intensive cleaning and sterilisation cycles that consume substantial quantities of purified water and cleaning chemicals. The environmental cost of producing and maintaining the complex utility infrastructure represents an often-overlooked component of their total environmental impact.
The Hybrid Revolution
The most sophisticated manufacturers are increasingly rejecting the false choice between single-use and multi-use technologies, instead embracing hybrid approaches that leverage the strengths of each system where they provide the greatest advantage.
A typical hybrid facility might utilise single-use bioreactors for upstream cell culture, capitalising on their flexibility and contamination control advantages, whilst employing multi-use chromatography systems for downstream purification, where the economics of scale provide clear benefits. This approach maximises flexibility during development phases whilst optimising cost-effectiveness for commercial production.
Process intensification offers promising pathways to overcome some traditional limitations of single-use technology. Techniques such as perfusion culture, continuous processing, and advanced process control can enable higher productivity within existing volume constraints, potentially extending the economic attractiveness of single-use systems to higher production volumes.
Making the Strategic Decision
The optimal technology selection requires systematic evaluation that considers both current requirements and future scenarios. Companies should begin by conducting a thorough assessment of their product portfolio, not just current products but potential future additions.
The risk assessment must be comprehensive. Single-use systems create supply chain dependencies that can be challenging to manage, particularly for critical components with long lead times. Multi-use systems create different risks around technology obsolescence and reduced flexibility to respond to market changes.
Companies with uncertain market prospects, multiple products in development, or capital constraints often find single-use systems more attractive. Organisations with established products, predictable high-volume demand, and substantial capital resources may benefit more from multi-use investments.
The most successful approach recognises that this isn't a permanent, irreversible choice. Manufacturing strategies can evolve, and many companies find value in starting with single-use systems during development phases, then evaluating multi-use alternatives as products mature and volumes increase.
Looking Forward
The pharmaceutical manufacturing landscape continues to evolve at an unprecedented pace. Emerging technologies like continuous manufacturing and process intensification are blurring traditional boundaries between single-use and multi-use approaches.
The most successful manufacturing strategies will be those that thoughtfully balance current operational requirements with future flexibility. The facility designed today must serve effectively for decades, making adaptability as important as current optimisation.
The choice between single-use and multi-use technology represents more than a technical decision, it's a strategic choice that reflects your organisation's risk tolerance, growth expectations, and vision for the future. In an industry where the only constant is change, the ability to make informed, flexible technology choices has become a critical competitive advantage that extends far beyond the factory floor.
The companies that master this decision-making process won't just build better facilities, they'll create manufacturing platforms that can evolve with the industry and respond to unexpected challenges in ways their competitors cannot. That's the true value of getting the technology choice right.