Single-Use in Biotech - Addressing Opportunities and Challenges
Over the past decade, the growth and adoption of single-use technologies in biomanufacturing has been steep and sustained. What began primarily with single use bioreactors has expanded to include single-use components from early upstream processes through downstream and into commercial manufacturing. As of 2018, single-use systems were being used for about 85% of preclinical and clinical biomanufacturing and are increasingly being incorporated into commercial manufacturing1. The benefits of single-use technologies have been well documented and include risk mitigation, increased efficiency, reduced personnel requirements, less validation time, and customizable solutions. The technology has also been found to reduce utility and water costs for cleaning and sterilization, as well as lower batch changeover time. This is particularly important for facilities that run smaller manufacturing lots, with several different products or are looking to maximize facility flexibility.
Opportunities
i.) Reduced Risk of Contamination
Single-use technologies are designed to be sterile, which reduces the risk of contamination. With traditional bioprocessing methods, cleaning and sterilization are time-consuming and may not always be effective, increasing the risk of contamination and subsequent loss of product. With single-use technologies, the risk of contamination is significantly reduced.
ii.) Lower Costs
Single-use technologies can reduce capital costs by eliminating the need for large stainless-steel bioreactors, cleaning and sterilization equipment, and associated infrastructure. Additionally, single-use technologies can reduce operating costs, as they require less energy and water.
iii.) Faster Turnaround Times
Single-use technologies can reduce processing time, as there is no need for cleaning and sterilization between batches. This can increase production capacity and reduce time-to-market for new products.
iv.) Greater Flexibility
Single-use technologies can be easily customized to meet specific process requirements, making them more flexible than traditional bioprocessing methods. This flexibility allows biotech companies to quickly adapt to changing market demands and develop new products.
Challenges
i.) Waste Generation
Single-use technologies generate more waste than traditional bioprocessing methods. The disposable plastic components used in single-use bioprocessing must be carefully disposed of to prevent environmental contamination.
ii.) Cost
While single-use technologies can be cost-effective in certain applications, they can be more expensive than traditional bioprocessing methods in others. For example, large-scale production may require multiple single-use bioreactors, which can be costly.
iii.) Scalability
Single-use technologies may not be suitable for all bioprocessing applications. While they are ideal for small to mid-sized batches, they may not be scalable for large-scale production.
iv.) Regulatory Approval
Some regulatory agencies may require additional testing and validation for single-use technologies before they can be used in production. This can add time and cost to the approval process.
In conclusion, single-use biotechnology offers several opportunities for the biotech industry, including reduced risk of contamination, lower costs, faster turnaround times, and greater flexibility. However, there are also challenges associated with single-use biotechnology, including waste generation, cost, scalability, and regulatory approval. Biotech companies must carefully evaluate the benefits and drawbacks of single-use technologies to determine whether they are suitable for their specific bioprocessing applications.