Single-Use Systems (SUS)

1. What are single-use systems?
2. How single-use systems work in biopharmaceutical manufacturing
3. Benefits of single-use systems in the pharmaceutical industry
4. Applications of single-use systems in biopharmaceutical production
5. Challenges and considerations
6. Key takeaways

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What are single-use systems? 

Single-use systems (SUS) are pre-assembled, disposable components used in biopharmaceutical manufacturing processes. Unlike traditional stainless-steel systems, SUS eliminate the need for cleaning and sterilization between batches, significantly reducing the risk of cross-contamination. Made from durable and sterile materials like plastic polymers, SUS are commonly utilized in processes such as cell and gene therapy, vaccine production, and monoclonal antibody manufacturing.

Single-use technology has become a cornerstone of modern biopharmaceutical manufacturing, offering flexibility and efficiency for both small-scale and large-scale production

How single-use systems work in biopharmaceutical manufacturing

Single-use systems integrate into various stages of biopharmaceutical production, replacing stainless steel equipment with disposable components. Key elements include:

Bioreactors: Single-use bioreactors are pre-sterilized and can be easily replaced after each batch, ensuring contamination-free processes.

Chromatography columns: Disposable columns streamline purification steps while maintaining high-quality standards.

Storage bags and tubing: Flexible containers and tubing systems are designed for aseptic fluid transfer and storage, supporting sterile operations.

By eliminating the cleaning and validation steps required for traditional systems, SUS enhance efficiency and reduce downtime in manufacturing processes.

Benefits of single-use systems in the pharmaceutical industry

The adoption of single-use systems offers numerous advantages for biopharmaceutical manufacturers, including:

Reduced risk of cross-contamination: Disposable components eliminate the need for cleaning, minimizing contamination risks.

Cost-effectiveness: SUS lower operational costs by reducing labor, water, and energy usage associated with cleaning and sterilization.

Flexibility and scalability: These systems are adaptable to varying production scales, making them ideal for clinical trials, cell and gene therapy, and commercial production.

Time efficiency: Faster setup and changeovers streamline production timelines, enabling quicker batch turnovers.

Enhanced supply chain sustainability: By reducing reliance on water and energy, SUS support environmentally friendly manufacturing practices.

Applications of single-use systems in biopharmaceutical production

Single-use systems are widely used across the biopharmaceutical industry for applications such as:

Cell and gene therapy: Flexible and sterile systems enable precise, small-batch production for personalized therapies.

Monoclonal antibody production: SUS ensure consistent quality in large-scale bioprocessing.

Vaccine manufacturing: Rapid scalability and ease of use make SUS ideal for meeting global vaccine demand.

Downstream processing: Single-use filtration and chromatography systems simplify purification workflows while maintaining sterility.

Challenges and considerations

While single-use systems offer significant benefits, they also present certain challenges:

Material limitations: Plastic components may not be suitable for all biopharmaceutical processes, particularly those requiring high temperatures or pressures.

Waste management: The disposable nature of SUS raises concerns about environmental impact and waste disposal.

Supply chain dependency: Manufacturers must rely on suppliers for high-quality, sterile single-use components.

Overcoming these challenges involves continued innovation in materials and processes to enhance the sustainability and versatility of SUS.

Key takeaways

• Single-use systems streamline biopharmaceutical manufacturing by replacing traditional stainless-steel equipment with disposable components.
• They offer advantages such as reduced cross-contamination risks, cost-effectiveness, and scalability.
• Applications range from cell and gene therapy to large-scale vaccine production.
• The future of SUS lies in material advancements and sustainable practices to address environmental concerns.

Resources

• FDA Guidance on Changes to Disposable Manufacturing Materials 
• WHO Guidelines on Biomanufacturing 

Related terms

Aseptic Isolator
Active Pharmaceutical Ingredient (API)
Good Manufacturing Practices (GMP)