Single-Use Technologies in Biologics Manufacturing: Benefits, Challenges, and Growing Demand

Single-Use Technologies in Biologics Manufacturing: Benefits, Challenges, and Growing Demand

Overview

  • Post By : Suresh Rathod

  • Source: Ami Polymer Pvt Ltd

  • Date: 09 Oct,2025

The increasing adoption of single-use technologies (SUT) in the biopharmaceutical industry is largely due to the added flexibility and cost reduction along with shortened marginal development times provided by SUT innovations. Unlike stainless steel systems SUTs virtually devoid of capital investments and also eliminate labor intensive cleaning and sterilization, while also containing the risk of contamination SC and streamlining production.

The demand for SUT biomanufacturing is described in the attached paper and the potential benefits and challenges it poses are detailed.

Single-use technologies (SUT) are disposable components such as bioreactors, tubing, filters, and storage bags, designed for a single use before disposal. SUT technologies were introduced in the early 2000’s and have expanded from basic buffer preparation to fully integrated complex bioprocessing for both the upstream and downstream.

The increase in the demand for biologics, vaccines, and personalized medicine has greatly accelerated the adoption of SUT technologies within the small to mid-scale production facilities and has begun to expand into the large-scale operations as well.

Opposed to stainless steel systems, which are costly and labor intensive, SUT systems allow for significant and rapid product turnover, greatly minimizing downtime and enhancing operational flexibility.

Benefits of Single-Use Technologies

SUT provides significant advantages that have transformed modern biomanufacturing.

Table 1: Benefits of SUT

SUT’s benefits have made it a cornerstone of biomanufacturing, especially during urgent healthcare needs such as the COVID-19 pandemic.

Implementation Challenges of SUT

Despite advantages, several limitations affect large-scale implementation.

Table 2: Challenges of SUT

Conclusion

Improvements in material science, hybrid systems, and recycling will likely address the challenges posed by waste management, supply reliability, and the regulatory environment. The benefits brought by single-use technologies – cost reduction, better flexibility, and speed – have positively transformed single-use systems in the manufacture of biologics. The ongoing shift in the industry toward more agile and personalized medicine will rely, to a significant extent, on the versatility in biomanufacturing offered by single-use systems.

Authored  by: Suresh Rathod

Assistant manager,
Bioprocess marketing & sales
[email protected]

About Author

Assistant manager, Bioprocess marketing & sales