ResourcesEnhancing Productivity and Efficiency in Biomanufacturing

Taylor Hayward

In the dynamic field of biopharmaceutical production, achieving optimal productivity and efficiency is crucial for success. With the rise of multi-product facilities focused on developing and manufacturing biologics like monoclonal antibodies, recombinant proteins, cell and gene therapies, and biosimilars, there is a growing demand for solutions that streamline processes. Ready-to-use disposable systems have emerged as a game-changer, offering a host of benefits such as minimizing the risk of cross-contamination, simplifying cleaning procedures, enabling faster product changeover, reducing R&D costs and capital investment.

Ready-to-use disposable systems significantly mitigate the risk of cross-contamination, especially at product-contact points, ensuring the integrity of each batch. They empower biomanufacturers to boost throughput and flexibility in facility design and operations. Notably, they also contribute to environmental sustainability by significantly reducing energy consumption, space requirements, steelwork, water usage, and cleaning chemical needs by up to 75%. Moreover, the Evolve® column range provides the advantage of resin retention, allowing for reuse if desired.

*As supplied the Refresh Kit and all its spare parts are fully recyclable. Please check with your local authorities before disposing of any parts to comply with your local regulations/guidelines.

Astrea Bioseparations is at the forefront of providing ready-to-use solutions for downstream bioprocessing. The portfolio includes pre-packed columns of various sizes, such as Evolve®D and SNAP®, as well as the innovative Evolve® range of repackable chromatography columns. The Evolve® columns feature disposable/replaceable process fluid contact pathways known as Refresh Kits. These kits offer an economical and convenient alternative to complete column replacement, allowing the wetted pathway to be renewed easily for continuous use.

**Based on 70 mm and 100 mm Refresh Kits versus column storage footprint.

In addition to reducing the need for time-consuming column cleaning and validation, Refresh Kits offer several advantages. They enhance flexibility, enable faster turnaround times between batches, and simplify product release procedures. By adopting Evolve® columns and Refresh Kits, biomanufacturers can significantly reduce chromatography preparation times and associated resource requirements. This translates into savings not only in terms of organic solvents and hazardous substances required for cleaning, but also disposal costs as well.

Refresh Kits are particularly beneficial in multi-product facilities, such as contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs). By minimizing the need for dedicated columns and extensive inventories, these kits drastically reduce downtime between products and batches. The Evolve® bioprocessing columns offer great flexibility, accommodating packed bed volumes of up to 130 L. Users can pack the columns with Astrea Bioseparations’ own chromatography media or their preferred resins. Remarkably, Evolve® columns are more cost-effective compared to equivalent fixed-volume disposable columns offered by other vendors, making them an ideal choice for companies operating multi-product facilities and undertaking short production campaigns at small to medium scale.

The adoption of ready-to-use disposable systems, such as Astrea Bioseparations’ Evolve® columns and Refresh Kits, holds immense potential for revolutionizing biomanufacturing processes. By enabling efficiency gains, reducing cross-contamination risks, and offering economic and environmental benefits, these solutions empower biomanufacturers to thrive in the fast-paced world of biopharmaceutical production.