Growing Demand Drives Changes in Industry Approach

The biopharmaceutical manufacturing industry has seen significant changes in recent years driven by growing worldwide demand for biologic drugs. One major shift has been the increased adoption of single-use assemblies for upstream and downstream processing. While traditional stainless steel assemblies were previously the standard, manufacturers are transitioning to single-use components due to various operational and economic advantages. This change represents a major trend that is expected to continue growing globally.

Efficiency Gains Through Flexibility and Scalability

A key factor driving the move to Single-Use Assemblies technologies is the improved flexibility and scalability they provide. With single-use technologies, manufacturers can more easily change production scales to meet fluctuating demand. Production capacity can be rapidly expanded or contracted by adding or removing single-use technologies rather than relying on large-scale stainless steel equipment. This provides significant efficiency gains compared to the time and expense required for cleaning and validation of stainless steel equipment between product changeovers or batch sizes. Single-use technologies eliminate cross-contamination risks and enable production to be quickly scaled up or down as needed.

Lower Capital Investments and Simplified Operations

In addition to operational flexibility, single-use technologies reduce the substantial capital investment required for large stainless steel production facilities. Single-use assemblies have a much lower capital cost compared to purchasing and qualifying expensive stainless steel equipment. Facility design and construction are also simplified without the need for complex piping and closed clean-in-place systems associated with stainless steel equipment. Operation and maintenance costs are lower long-term due to less cleaning and sterilization requirements compared to reusable assemblies. These economic benefits have made single-use a particularly attractive option for smaller biopharma companies and contract manufacturers.

Enhanced Product Quality Through Containment

Ensuring product purity and preventing cross-contamination are crucial for biologic drugs given their complex manufacturing processes. A key advantage of single-use technologies is the reliable containment they provide to eliminate any risk of contamination between product batches, cell lines or products. As single-use components are disposed of after each use, there is no need for time-consuming cleaning and sterilization validations required for steel equipment. This enhances overall product quality assurance and results in less wasted materials from poor or failed cleaning validations compared to traditional stainless steel-based systems. Single-use technologies effectively eliminate product quality issues related to cleaning residue or carryover contamination.

Rising Global Adoption Driven by Cost Savings

These operational, economic and product quality benefits have driven significant adoption growth globally over the past decade, especially in high-wage countries. While the initial cost of single-use assemblies may be higher due to single-use material costs, the savings from reduced validation, cleaning and sterilization requirements generate substantial total cost reductions long-term. A 2016 survey found over 80% of biomanufacturers globally using or evaluating single-use technologies to some degree. Those already implementing single-use reported capital and operational savings between 20-40% versus stainless steel infrastructure. The same study predicted single-use would grow to constitute over 60% of the global market for bioprocess equipment by 2025.

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