Single-use bioreactors (SUBs) are advanced vessels designed for the cultivation of cells or microorganisms in biopharmaceutical manufacturing. Unlike traditional stainless-steel bioreactors, which require cleaning and sterilization between batches, single-use systems use disposable bags or liners that are pre-sterilized and discarded after each production run.
They exist to address a long-standing challenge in the biopharmaceutical industry — the need for flexible, contamination-free, and cost-effective production of biologics such as vaccines, antibodies, and cell therapies. As the demand for faster and smaller-scale bioprocessing grows, SUBs offer a solution that supports both innovation and efficiency.
The global biopharmaceutical industry is evolving rapidly, with an increasing shift toward personalized medicine, small-batch production, and agile manufacturing models. Single-use bioreactors have become a cornerstone technology in this transformation.
Key Advantages
Flexibility: Easily adaptable to various scales and production types — from clinical trials to commercial batches.
Reduced Contamination Risk: Pre-sterilized systems eliminate the need for in-place cleaning or steam sterilization.
Lower Capital Costs: No expensive stainless-steel cleaning systems or infrastructure required.
Faster Turnaround: Enables rapid changeover between batches, essential for multiproduct facilities.
Sustainability: Uses less water and chemicals for cleaning, reducing environmental impact.
For small and medium biopharma firms, SUBs also lower the entry barrier to advanced biologics manufacturing — enabling innovation without major capital investment.
The single-use bioreactor market has evolved significantly in recent years due to technological advancements, supply chain shifts, and increased biologics demand.
| Year | Development | Impact |
|---|---|---|
| 2024 | Widespread adoption of 2,000L SUBs for commercial production | Larger-scale disposable systems became standard in monoclonal antibody manufacturing. |
| 2024–2025 | Integration of automation and real-time analytics | Enhanced process control using AI and digital twins for bioprocess optimization. |
| 2025 | Hybrid facilities combining stainless steel and single-use systems | Flexible manufacturing models adopted by large CDMOs and pharma companies. |
| 2024 | Supply chain diversification post-pandemic | Increase in local production of disposable bags and sensors. |
| Ongoing | Focus on sustainability and recyclability | Development of recyclable polymers and energy-efficient processes. |
According to market analyses, the global SUB market is expected to exceed USD 8 billion by 2028, with a CAGR of over 15% (2023–2028), driven by growth in biologics, vaccines, and cell-based therapies.
Single-use technologies (SUTs) are regulated under global pharmaceutical manufacturing frameworks to ensure product safety, sterility, and consistency.
Key Regulatory Bodies and Standards
U.S. Food and Drug Administration (FDA): Requires validation of single-use components and materials per 21 CFR Part 211 (Good Manufacturing Practice for Finished Pharmaceuticals).
European Medicines Agency (EMA): Evaluates extractables and leachables (E&L) from plastic materials.
ISO 10993: Standards for biocompatibility of medical and bioprocessing materials.
USP <665> and <1665>: Testing guidelines for polymer-based manufacturing systems used in pharmaceutical production.
PIC/S and WHO GMP Guidelines: Global frameworks governing biopharmaceutical manufacturing practices.
Compliance Priorities
Manufacturers must validate:
Sterility assurance levels (SAL)
Chemical compatibility with process fluids
Absence of harmful extractables or leachables
Mechanical and temperature stability
These regulations ensure that the use of disposable systems does not compromise product quality or patient safety.
Single-use bioreactors come in several configurations depending on mixing method, scale, and application.
| Type | Mixing Mechanism | Typical Volume Range | Common Applications |
|---|---|---|---|
| Stirred-Tank SUBs | Mechanical impellers for mixing | 50L – 2,000L | Cell culture, monoclonal antibodies |
| Wave-Mixed SUBs | Rocking motion creates waves | 10L – 500L | Early-stage R&D, vaccine production |
| Air-Lift SUBs | Gas sparging for circulation | 50L – 1,000L | Microbial fermentation, plant cells |
| Hollow-Fiber SUBs | Membrane-based nutrient exchange | 1L – 50L | Perfusion cultures, cell therapy |
| Hybrid SUBs | Combination of mixing and gas flow | 100L – 2,000L | Continuous and perfusion bioprocesses |
| Feature | Single-Use Bioreactor | Stainless-Steel Bioreactor |
|---|---|---|
| Setup Time | 1–2 days | 1–2 weeks (cleaning & validation) |
| Cleaning/Sterilization | None required | CIP/SIP systems needed |
| Capital Cost | Low | High |
| Operational Cost | Moderate (disposables) | High (utilities, cleaning) |
| Cross-Contamination Risk | Very low | Moderate |
| Environmental Impact | Lower water/energy use | Higher resource consumption |
| Scalability | Flexible for small to medium scale | Suitable for large-scale, fixed processes |
In modern biomanufacturing, hybrid facilities increasingly use both — single-use systems for flexible, small-batch operations and stainless steel for large, continuous production.
The following tools, databases, and organizations help support the effective use of single-use bioreactors in industry.
Design and Simulation Tools
BioSolve Process (by Biopharm Services): Cost modeling for single-use vs. stainless-steel systems.
Aspen Plus & COMSOL Multiphysics: Process simulation and flow analysis.
MATLAB Bioprocess Toolbox: Dynamic modeling of cell growth and nutrient flow.
Monitoring and Analytics
Raman & Near-Infrared (NIR) Sensors: Real-time monitoring of glucose, lactate, and pH.
SCADA & PAT Systems: Automation and process analytics per FDA’s “Quality by Design” (QbD) framework.
Industry Resources
BioProcess International (BPI): Industry reports and technical publications.
ISPE (International Society for Pharmaceutical Engineering): Guidelines on single-use technology implementation.
BioPhorum Operations Group (BPOG): Standards for E&L testing and best practices.
Despite clear advantages, SUBs also present operational and environmental challenges that must be managed:
Waste Management: Disposal of large volumes of plastic materials.
Mechanical Integrity: Risk of leaks or film puncture under pressure.
Material Compatibility: Ensuring chemical stability of bag films and tubing.
Limited Scale: Currently suitable up to 2,000L for most applications.
Supply Chain Dependence: Reliance on certified vendors for single-use components.
Manufacturers are addressing these challenges through closed-loop recycling, stronger polymer films, and modular process design.
Q1: What makes single-use bioreactors “single-use”?
They use disposable, pre-sterilized liners or bags that are replaced after each production batch, eliminating the need for cleaning or sterilization.
Q2: Are single-use bioreactors safe for large-scale manufacturing?
Yes. Modern SUBs up to 2,000L have proven reliable for commercial biologics production, particularly in monoclonal antibody and vaccine manufacturing.
Q3: Do single-use systems generate more waste?
While they produce plastic waste, they consume significantly less water and energy compared to traditional systems. Some suppliers now offer recycling programs for used liners.
Q4: How are extractables and leachables tested?
Manufacturers perform chemical testing (per USP <665> and <1665>) to ensure no harmful substances migrate into the product during processing.
Q5: What is the future trend in single-use technology?
Expect wider adoption of hybrid facilities, smart sensors, and AI-driven process control — enhancing both sustainability and production efficiency.
Single-use bioreactors are transforming how biologics are developed and produced. By enabling faster setup, lower costs, and flexible scaling, they align perfectly with the growing demand for personalized medicines and rapid-response vaccines.
As regulations evolve and recycling technologies improve, the future points toward smart, automated, and eco-efficient biomanufacturing facilities — where single-use systems play a central role in ensuring safety, quality, and accessibility of next-generation therapies.