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WHY OUTSOURCE COLUMN PACKING?

Column chromatography is a well-established separation technique used throughout process development, clinical manufacturing, and commercial production of biopharmaceuticals. Fundamental to its success is the ability to effectively and consistently pack resin into column hardware.

As biopharmaceutical demand continues to grow, optimizing column packing processes remains critical to operational success and long-term sustainability in the competitive biomanufacturing landscape. Outsourcing this time-consuming and labor-intensive step can improve process efficiency and free up valuable resources.

Astrea Bioseparations supports this need with an extended Evolve®D range of pre-packed columns, with expert column packing service.

Successful chromatographic separations in the downstream processing workflow rely on effective column packing. By ensuring uniform flow distribution, minimizing pressure drops, and maintaining consistent packing conditions, biopharmaceutical manufacturers can improve process efficiency and safeguard the integrity of their therapeutic products.

Despite the challenges and substantial internal resources, many biopharmaceutical companies choose to pack their chromatography columns in-house. Selfpacking not only involves the column packing step itself, but also requires validation through efficiency testing and stringent bioburden checks to protect against contamination in downstream processes.

The consequences of improperly packed columns can be far-reaching. Among the most significant drawbacks is the potential need to repack or replace a column that has failed validation tests. Column failure requires unpacking, cleaning, repacking, and retesting, causing delays in production and potentially halting an entire bioprocess. Such delays are particularly costly in large-scale manufacturing, where other parts of the production process may be forced to wait for chromatography steps to be completed. Manufacturing consistency and reproducibility are key to ensuring regulatory standards are met.

An increasing number of companies are benefitting from outsource their column packing operations.

Astrea Bioseparations’ Evolve®D columns are available pre-packed, enabling biopharmaceutical companies to achieve timely delivery of prequalified, ready-touse columns that are accompanied by all necessary documentation to integrate column quickly into downstream processing lines, saving valuable time and resources.

Benefits of outsourcing column packing

Time efficient

• Elimination of the packing process; increasing number of runs, leading to increased productivity

• Quick setup and changeover, critical for continuous or high-throughput processes

• Faster transitions in multi-product facilities or CDMOs

• Delivered to integrate into your production schedule

Resource savings

• Cost effective: Compared to in-house packing

• Labor saving: In-house column packing requires specialized personnel and significant labor hours

• Space saving: No need for dedicated packing suites or additional equipment

• Materials saving: No need for required for packing (buffers, solvents, etc.)

• Resource saving: Reduced water and energy costs

Quality assurance

• Columns packed in ISO 7 cleanrooms

• Consistent performance

• Prequalified and bioburden tested

• Documentation provided for seamless process integration

Enhanced consistency

• Prepared under controlled conditions, ensuring consistent packing density

• Outsourced packing reduces the risk of human error and inconsistencies

• Consistent performance and documentation associated with pre-packed columns can simplify regulatory compliance

EVOLVE®D COLUMNS

Evolve®D columns are a purpose-designed range of pre-packed columns, providing a convenient plug-and-play solution for process chromatography. Built on the proven, scalable design and reliability of the Evolve® Process range. Additional design features combine practicality with cleanability, making them a valuable addition to any process suite.

Evolve®D columns: Designed for commercial production

Astrea Bioseparations’ Evolve®D pre-packed columns offer scalable, high-quality solutions for diverse bioprocessing needs.

This range of pre-packed columns are designed to be a plug-and-play unit, suited for use in a single production campaigns, thus eliminating the need for cleaning, validation, and mitigating the risk of carryover contamination.

A wide range of resins, produced both by Astrea Bioseparations and by third-party suppliers, can be packed using customer-specified methods and over a range of bed heights. On smaller diameter columns, commonly used bed heights are available as standard, whereas on columns 250–600 mm customers can specify bed heights up to 40 cm.

Our team of Field Application Specialists are on-hand to discuss and assist in defining your packing requirements. Each pre-packed column is supplied with the necessary certification to allow columns to seamlessly fit into the process workflow. Chromatographic performance, pressure characteristics, and bioburden information are provided as well as material compliance information.

Performance scales seamlessly across the Evolve®D and Evolve® Process column ranges, allowing transition from process development studies using this column format.

Columns are packed in an ISO 7 cleanroom environment at globally convenient locations. Supply schedules and contracts can be set up to ensure continuity and consistent availability.

Columns are designed to be maintenance-free and require no additional lifting apparatus to remove the column from shipment crates. Columns of diameters 70–200 mm are designed to sit on work bench whereas columns of diameters 250 mm and above can be wheeled into the process suite.

Flexible resin choices

• Pre-packed columns available for all Astrea Bioseparations resins

• Also supports third-party resin suppliers

• Wide range of packable resin types

• Evaluation of used resin available

Column hardware options

• Range of column diameters available 70–600 mm

• Standard bed height on smaller diameter columns

• Customer-specified bed height up to 40 cm on larger process columns

• Manufactured using bioprocess-ready materials

• Includes a non-metallic flow path compatible with high halide solutions and guanidine HCL

• Optimized inlet and outlet sizes to accommodate range of process flow rates and minimize pressure drop

Column performance

• Packed bed qualified using standard techniques (HETP, Asym, ΔP)

• Bioburden study performed and result provided

• Performance scalable and comparable to Evolve® Process columns

Global experts & support

• Expert column packing operatives based in Europe (Isle of Man) and US (Canton, MA)

• Global team of Field Application Specialists (FAS)

• Documentation provided for seamless process integration (RSF, CofA)

SNAP®,EVOLVE®S, & EVOLVE®R

Astrea Bioseparations offers a comprehensive column range, in-house packing expertise, and pre-packed column solutions to support customers looking to outsource column packing across process development and small-scale manufacturing applications.

Lab-scale: SNAP® chromatography columns

SNAP® columns provide a high-performance laboratory platform for process development and small-scale purification.

SNAP® are available empty, pre-packed with Astrea Bioseparations media, or customer-specified resins.

Key features

• Precision glass construction with graduated scales for quick, easy, and accurate bed height determination

• Pressure compatibility up to 40 bar

• Linear piston motion to eliminate torsional stress on chromatography medi

• Rapid assembly and disassembly via quick-release clamps

• Compatibility with a wide range of chromatography media

Pre-packed SNAP® columns eliminate variability associated with manual packing while accelerating development timelines.

Process development and small-scale manufacture: Evolve®R and Evolve®S

Evolve®R and Evolve®S columns provide convenient, ready-to-use pre-packed chromatography solutions that plug directly into your process development or smallerscale applications.

Key features

• Achieve endotoxin clearance to below 0.1 EU/mg protein and ≤0.05 EU/mL from a range of buffers

• Compatible with a wide range of proteins

• Also available as an adsorbent slurry for column packing and an extensive range of disposable columns to suit your process requirements

Evolve®S columns are packed under ISO 7 cleanroom conditions and supplied fully qualified and certified, with Regulatory Support File available upon request.

Evolve®R columns are supplied fully qualified with CoA available upon request.