Single-use technology & the implementation in biopharma

Why are so many biopharma manufacturers adopting single-use technology instead of traditional stainless-steel systems?

The answer goes far beyond convenience. Single-use technology has become one of the most transformative developments in modern biopharmaceutical manufacturing, helping companies improve flexibility, reduce contamination risks during the handling of bulk drug substance, and improve overall cost-effectiveness across their operations. As biologics, cell and gene therapies, and other advanced therapeutics drive demand for more agile manufacturing approaches, single-use technology has evolved from a niche solution into an established industry standard.

But how did this transformation happen, and what benefits continue to drive its widespread adoption across bioprocessing and biopharmaceutical production?

Overview of biopharma processes

Trend towards Single-Use Technologies

It is a well known fact that this industry is changing incrementally due to strict regulatory regulations. While some single-use components, such as tubing and filter cartridges, have been in use for quite some time and their markets approaching saturation, several products were just recently introduced on commercial scale, e.g. disposable chromatography devices, media bags and tangential flow filtration devices. Their markets even showed double-digit growth rates in 2017.[[1]]

Are single-use technologies more sustainable than stainless-steel equipment?

Aligned with ESG goals for clean water and sanitation, single-use technologies conserve resources used for biomanufacturing[[2]]:

• 87% less water, mainly achieved due to the reduced requirement for cleaning
• 95% fewer chemicals, equally due to reduced cleaning and sterilization
• 30% less electricity, which stems from the smaller footprint of facilities and equipment

Those are astonishing and especially promising numbers and would help improve the biopharma industry, not only in making production smarter and cheaper, but also by keeping supply chains intact. 

Adding to that, this shows, today, single-use systems challenge the procedure of re-using stainless-steel equipment, which was an established technique in biopharmaceutical manufacturing, that entails complex cleaning processes to avoid risks such as cross-contamination or the failure to achieve sterility.

Single-use systems in Biopharma - an overview from the beginning

Single-use technologies have been in use since the early 1990s. Due to the need to move ever-increasing volumes of serum, biotech labs initially started using plastic bags common in the food industry. 

Once the serum arrived at the manufacturers’ labs packaged in plastic bags, it didn’t take long for them to start imitating and adopting this type of container for their high-quality drug substance. Consequently, this brought with it the need for specific technologies geared towards single-use consumables that were both flexible and scalable. 

While avoidance of tedious and costly cleaning and maintenance processes were the initial drivers for the development of single-use technologies, they are now not only seen as more cost-effective, but also as a safer alternative to traditional technologies. Since then, major milestones have been achieved.

In the early 2000s, aseptic disposable sampling systems have been introduced. Another milestone was the introduction of single-use bioreactors. Manufacturing facilities realized the immense advantages of single-use technology for the pharma industry, e.g. in gene therapy. Since then, many single-use facilities have been opened and counting. For example, in 2017 already 66% of pharmaceutical companies preferred single-use bioreactors over the traditional stainless-steel bioreactors.

And the figures from the previous paragraph on the trend toward single-use technology show that the development is still continuing. But why exactly are so many manufacturers switching to single-use systems?

What are the main advantages of using single-use technologies?

Single-use technologies offer a combination of flexibility, scalability, and contamination control that has significantly transformed modern biopharmaceutical manufacturing. Preassembled, pre‑sterilized containers and fluid pathways enable closed and aseptic processing, reducing the risk of cross-contamination while minimizing the need for cleaning and sterilization between batches. This not only accelerates production workflows and shortens changeover times, but also supports cGMP-compliant manufacturing from process development through commercial production.

A key advantage of single-use technology is its ability to provide a streamlined, scalable process across different manufacturing stages. The same platform can often be used from early process development and pilot-scale operations through to large-scale commercial manufacturing, facilitating process transfer and reducing scale-up challenges. As production volumes continue to increase, manufacturers require technologies that can efficiently bridge the gap between small development batches and high-volume commercial production without compromising process consistency or product quality. Single-use platforms, particularly when implemented as closed systems, support reproducibility and contamination control across scales, thereby improving overall process robustness.

These benefits have driven the widespread adoption of single-use systems across a broad range of applications, including monoclonal antibodies, vaccines, viral vectors, mRNA-based therapeutics, and cell and gene therapies. In particular, emerging modalities often require flexible manufacturing setups, smaller batch sizes, rapid product changeovers, and strict contamination control under GMP conditions – all areas where single-use technologies excel. In addition, modern single-use platforms can integrate components such as filters, single-use sensors, and sampling systems as needed, creating modular and adaptable process solutions tailored to specific manufacturing requirements. These systems can be configured as closed, automated workflows, minimizing human intervention and further reducing contamination risk while enhancing process efficiency.

Single-use bioprocessing - read more

Cost efficiencies with single-use technologies

As a result of the application of single-use technologies (SUT), the manufacturers can rely on financial assets. With the switch to single-use tubing assemblies, costs are reduced in many ways.

• Cost reduction through time savings
• Cost reduction through energy savings
• Cost reduction through water savings 
• More favorable CO2 footprint
• Less instrumentation/utility demand required
• Lower risk of contamination 
• Lower investment costs
  • more capacities can be purchased with limited start-up budget
  • investment sum to be amortized is lower
  • overall, variable costs are lower

The reduction in costs is just one of the numerous advantages of using SUT in biopharmaceutical manufacturing. The simplified application also promises advantages for the user. Find all the benefits of single-use systems in the specific fields of application in the following paragraphs. (Source: NNE, Beroe)

Flexibility and scalability of single-use platforms

While conventional stainless-steel systems have been established as the basis of safe and reliable manufacturing processes for both classical pharmaceuticals and advanced biologics over decades, they are not exactly flexible. However, the complex processes involved in the production of biopharmaceutical compounds require great flexibility, while they should at the same time be cost-efficient. 

This is where disposable single-use components come into play: Not only do they reduce the risk of cross contamination, they are also less expensive, easier to use and provide more process flexibility than traditional processing technologies. 

The advantages that set them apart from the traditional and rather unwieldy stainless-steel systems and cryovessels speak for themselves, even at a glance:

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