Single-Use Bioreactor Systems

Single-use bioreactors are disposable systems that replace traditional stainless-steel or glass vessels with pre-sterilized plastic bags for cultivating cells, particularly mammalian cells. They typically use either integrated stirrers or rocking motion platforms to achieve mixing. Because sensors must be embedded during manufacturing, these systems rely on preconfigured, non-invasive analytical probes for parameters such as pH, oxygen, and glucose. Their adoption has expanded across bioprocessing due to reduced cleaning, sterilization, validation, and turnaround times, enabling faster process changeovers and lowering operational costs. Despite limitations in oxygen transfer and scale-up compared with stainless-steel systems, single-use technologies remain advantageous for R&D and clinical-stage manufacturing where flexibility is essential. Environmentally, they reduce water, energy, and detergent consumption, although they generate more disposable plastic waste that is commonly incinerated for energy recovery.read more

Key Features

  • Single-use bioreactors offers miniature 15 mL systems to large-scale 2,000–5,000 L units, enabling seamless scale-up and scale-down. This continuity allows the same process principles to be maintained from early development through clinical and commercial manufacturing.
  • Advanced sparging designs, such as drilled-hole spargers and crossflow spargers, improve the volumetric oxygen mass transfer coefficient (kLa), carbon dioxide (CO₂) stripping, and uniform oxygen delivery. Modern drive-train and impeller options further optimize mixing with minimal shear, supporting high-density and microcarrier-based cultures.
  • Pre-sterilized bags with integrated components eliminate vessel cleaning, shortening turnaround times and reducing water, steam, and detergent consumption. “Plug-and-play” connection systems make installation rapid and minimize training requirements.
  • Films such as Flexsafe® and Aegis5-14 provide excellent biocompatibility, low extractables, and consistent growth of variety of cell lines. These materials also offer strong mechanical robustness and long-term supply assurance through controlled raw-material sourcing.
  • High turndown ratios allow multiple process stages to run in a single vessel, reducing the number of reactors and bags needed. This results in lower expenditure, better use of facility space, and increased throughput without expanding the production footprint.
  • Integrated non-invasive sensors and lower probe-cutout designs ensure accurate control of pH, DO, temperature, and other key parameters. Compatibility with platforms such as DeltaV-based G3 controllers and TruBio software supports robust data management, automation, and reproducibility.
  • Solutions are available for stirred-tank, rocker-based, and perfusion applications, covering suspension, adherent, and microcarrier processes. This versatility makes single-use systems suitable for seed train intensification, process development, cGMP manufacturing, and high-performance production.

Applications of Single-Use Bioreactors

  • Small-scale and early-stage research: Small-scale cell culture is performed to support exploratory studies and rapid experimental cycles. Laboratory research benefits from easy setup and flexible operation, enabling efficient testing of variables. Suspension cell lines are screened to identify high-performing clones for downstream development.
  • Process development and optimization: Process optimization focuses on refining parameters such as mixing, aeration, and feeding strategies to enhance overall productivity. Antibody development workflows use these systems for early-stage expression testing and clone evaluation. Virus production is supported through controlled environments ideal for preliminary vaccine or vector studies, and process intensification helps maximize yield within limited volumes.
  • Clinical-scale and mid-stage manufacturing: Clinical-scale expansion ensures that cell cultures reach the required volumes for therapeutic applications. Protein production at pilot or clinical levels benefits from consistent, controllable environments. Harvest process control maintains batch quality and supports efficient downstream processing.
  • Large-scale and commercial manufacturing: Large-scale culture enables robust production of commercial biopharmaceuticals. Commercial manufacturing relies on stable, reproducible performance across repeated batches. Regulatory-focused production emphasizes compliance with cGMP standards and reliable documentation throughout the process.
  • Cell and gene therapy applications: Pluripotent stem cell and mesenchymal stem cell manufacturing requires gentle, well-controlled environments that support cell integrity. Cell therapy workflows benefit from closed, scalable systems that minimize contamination risk and enable consistent expansion of therapeutic cell populations.

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Frequently Asked Questions

Which single-use bioreactor manufacturers are known for reliability and strong technical support?
Several companies stand out for reliable single-use bioreactor (SUB) systems and good global support, including Thermo Fisher Scientific, Sartorius (often via its Bioprocess Solutions division), and PBS Biotech. These providers have long-established portfolios covering small-scale research to large-scale manufacturing and maintain global networks of support and supply for bags, sensors, and controllers.
How does single-use bioreactor automation improve process consistency and data accuracy?
Automation ensures that parameters like temperature, dissolved oxygen (DO), pH, and gas flow are maintained within precise set ranges, minimizing human error and batch-to-batch variability. Integrated sensors and control platforms thus provide reproducible conditions and reliable, real-time data logging for better process monitoring and comparability across runs.
What factors should I consider before buying a single-use bioreactor system for my lab?
You should evaluate the scale and flexibility you need, whether for small-scale research or large-volume production, because bag volume, vessel design, and scale-up capability vary widely between systems. Consider oxygen transfer and mixing performance, especially if you plan high-density or microcarrier-based cultures, since inadequate kLa or poor mixing can limit viability or yield. Also assess operational and consumable costs, and supply chain reliability for consumables (bags, sensors, connectors), because recurring bag or sensor costs and good availability are crucial for long-term workflows.
4. Are single-use bioreactors suitable for microbial as well as mammalian cell cultures?
Yes, single-use bioreactors can be used for microbial fermentations as well as mammalian cell culture, though microbial applications have been less widespread historically. That said, microbial cultures often require high oxygen transfer and mixing rates, so not all SUB designs may support dense microbial growth equally well. If you intend to use single-use bioreactors for microbial culture, you should ensure the system offers sufficient aeration and mixing.