The biopharmaceutical industry faces challenges in standardizing single-use (SU) technologies, despite their advantages in production. The lack of standardization and limited flexibility in changing design hinder the automation of SU systems. Dependency on certain suppliers and the risk of shortages during crises are also concerns. However, SU systems are widely used and offer benefits such as increased flexibility, reduced contamination risks, and lower costs.
Introduction:
The lack of standardization of single-use (SU) technologies in the biopharma industry is a challenge for the move towards digital manufacturing. While SU systems have many advantages, such as increased flexibility, scalability, and lower costs, the lack of standardization and limited design flexibility hinder their adoption. This lack of standardization is due to the dynamics of the technology supply market and can lead to a dependency on certain suppliers. Therefore, it is crucial for biopharmaceutical companies to have a risk mitigation strategy that includes multiple suppliers and direct contracts with manufacturers of SU components.
- Single-use (SU) technologies are widely used in the biopharma industry and offer advantages such as increased flexibility, scalability, and lower costs.
- The lack of standardization and limited design flexibility of SU systems pose challenges for their adoption in the industry.
- The choice of SU technologies is smaller compared to traditional manufacturing technologies, which can lead to a dependency on certain suppliers.
- A risk mitigation strategy that includes multiple suppliers and direct contracts with SU manufacturers is important to address the lack of standardization.
- The COVID-19 pandemic highlighted the need for a risk mitigation strategy in the biopharma industry, as there were shortages of consumables for SU systems.
Conclusion:
The lack of standardization of single-use technologies poses a challenge for the biopharma industry. While SU systems offer advantages such as increased flexibility and lower costs, their adoption is hindered by the lack of standardization and limited design flexibility. Biopharmaceutical companies should implement a risk mitigation strategy that includes multiple suppliers and direct contracts with manufacturers to address this challenge and ensure a stable supply of SU components.