Single-Use vs. Stainless-Steel Bioreactors: Which Manufacturing Platform Is Better for Biopharmaceutical Production?

Single-use bioreactors replace the traditional vessel with disposable polymer biocontainers that are presterilized and installed within reusable support structures. After the production run, the biocontainer is discarded and replaced with a new one for the next batch.

Because single-use systems eliminate CIP and SIP steps, they can dramatically reduce turnaround time between batches and simplify facility operations.

One of the most significant advantages of single-use systems is the reduction in upfront facility investment. Stainless-steel manufacturing plants require extensive infrastructure, including clean steam generation, water-for-injection systems, and dedicated cleaning systems.

Single-use facilities can be constructed more quickly and with less complex infrastructure, reducing capital expenditures and accelerating time to operation.

Single-use systems are particularly attractive for multiproduct facilities or contract manufacturers that need to rapidly switch between production campaigns. Because the disposable biocontainers are replaced after each run, the risk of cross-contamination is reduced and changeover times are minimized.

Stainless-steel systems are generally optimized for long-term production of a small number of products and are less flexible when frequent changeovers are required.

Stainless-steel systems still offer advantages at very large production scales. Large commercial biologics facilities often operate bioreactors with volumes exceeding 10,000–20,000 liters.

Single-use systems have historically been limited to smaller scales, though recent advances have pushed their capacity into the several-thousand-liter range, allowing them to support many commercial biologics programs.

The sustainability debate between single-use and stainless systems is complex.

Single-use technologies generate solid plastic waste from disposable biocontainers and tubing. However, they often consume significantly less water and energy because they eliminate large-scale cleaning and sterilization processes.

Stainless-steel facilities generate less solid waste but require large quantities of purified water, steam, and cleaning chemicals, which can increase energy consumption and wastewater generation.

The environmental footprint of each approach therefore depends heavily on facility design and operational practices.

Both single-use and stainless-steel systems are widely accepted by regulators and have been used in the production of approved biologics.

Regulatory concerns related to single-use systems typically focus on extractables and leachables from polymer components, which must be carefully characterized during process development.

Stainless-steel systems, while historically well understood, require robust validation of cleaning procedures to ensure that residues and cross-contamination risks are adequately controlled.

In practice, both platforms can support highly controlled GMP manufacturing environments when properly validated.

Single-use bioreactors are generally preferred when:

• facilities must support multiple products

• rapid facility deployment is required

• development or clinical-stage production demands flexibility

• manufacturing campaigns are relatively short or variable

• Stainless-steel bioreactors are often preferred when:

• production volumes are very large and consistent

• long-term commercial manufacturing is expected

• facility infrastructure already supports stainless systems

• economies of scale outweigh flexibility considerations

Neither platform is universally superior; instead, each aligns with different manufacturing strategies.

Single-use bioreactors excel in flexibility, speed, and lower capital investment, making them well suited for modern multiproduct facilities and emerging biologics programs.

Stainless-steel bioreactors remain advantageous for large-scale, high-volume manufacturing, where long-term efficiency and infrastructure stability are critical.

As a result, many manufacturers now adopt hybrid manufacturing models, combining single-use upstream bioreactors with stainless-steel or mixed downstream processing systems.