Sartobind® Rapid A for mAb Purification
Increasing Productivity in Protein A Capture
Conventional mAb purification steps with resin-based chromatography are currently held back by low productivity, laborious cleaning requirements, and high costs related to resin underutilization.
Sartobind® Rapid A, a ready-for-use chromatography membrane, simplifies setup and reduces column packing and handling time. Designed to maximize membrane lifespan, it provides a versatile solution for Protein A affinity chromatography in multi-product facilities, enabling efficient and cost-conscious processing, especially in process development and early clinical phases.
Sartobind® Rapid A offers a true scalable alternative to Protein A resins:
- Same bed-height in all formats
- Modular cassette format for larger processing volumes
- Scales seamlessly from process development to commercial production.
Sartobind® Rapid A reduces processing and validation time, accelerating speed to market:
- Short cycling times and high flow rates
- Easy handling, ready for use
- No column handling and storage
- Combined process development and characterization to quickly explore multiple conditions
- Scale-down models for process validation and qualification supported by data analytics software and process experts
Sartobind® Rapid supports a conscious approach to cost optimization throughout the drug life cycle of a molecule:
- Improved utilization of chromatographic media lifespan
- Smaller bed volumes required
- Reduced upfront investment in chromatographic media during process development and early clinical phases
Sartobind® Rapid helps increase productivity beyond time savings:
- High binding capacity, short residence times, and low operating pressure
- Column packing, handling, and testing are not required
- Compact footprint during both operation and storage
- Flexibility makes it easy to adapt to demand fluctuations
- Supports process intensification in batch mode or as a step toward a continuous multi-membrane approach
Explore Sartobind® Rapid A
Sartobind® Rapid A Portfolio Overview
The Sartobind® Rapid A product family offers various formats to suit different process scales and application needs. Additionally, the Protein A ligand is also available separately as reference material for leached Protein A analytics.
Sartobind® Rapid A 96-well Plates
Sartobind® Rapid A 96-well plates are ideal for high-throughput screening of production and purification conditions during mAb process development.
Sartobind® Rapid A Capsules
Sartobind® Rapid A capsules are a family of fully closed membrane chromatography formats designed for efficient mAb capture. The range of available sizes, directly scalable between each other, provides the necessary flexibility to accommodate different process demands.
Sartobind® Rapid A 0.8 L Cassette
The modular concept of the Sartobind® Rapid A cassettes enables larger-scale purification of mAbs while retaining direct scalability to the capsule portfolio.
Sartobind® Rapid A Ligand
The Sartobind® Rapid A Ligand is a recombinant Protein A expressed in Escherichia coli to be used as a reference material for ELISA-based quantification of leached Protein A in eluate fractions of Sartobind® Rapid A. It streamlines quantification, ensures consistent results, and offers easy solubilization with clear, user-friendly instructions.
Performance Deep Dive
Insights From a 200 L Case Study
Protein A affinity chromatography is typically the most costly and time-consuming step in the mAb purification process. Despite extensive efforts, only a small fraction of molecules entering the development pipeline reach the late clinical stage. To minimize time and investment in purifying material for early clinical phases, Sartobind® Rapid A provides a platform that aligns with these objectives.
Case-Study Assumptions: Process projections for 4 x 200 L batches at 5 g/L including validation steps (engineering run, process characterization, scale-down qualification, small shelf-life study), system flow kit, media and buffer costs.
Cost per Batch
- Costs of unit operations reduced by > 40%
- More efficient media utilization
Number of Columns and Media Volume
- Active capture time reduced by 75% and preparation time reduced by 66%
- All column handling operations removed
Process Time and Number of Cycles
- Reduce active capture time by 75% and preparation time by 66%
- Remove all column handling operations
Related Assets
You Are Still Free to Switch Later
The Protein A affinity chromatography media does not need to be set in stone at the earliest stages of the molecule development pipeline. Biophorum proposes a simpler and more pragmatic approach to registering this type of material. Instead of registering a specific Protein A media, the application focuses on critical material attributes and product control strategy.
- Minimize the impact
- Enable an easy switch to adjust the manufacturing strategy to meet demand
- Improve the quality of regulatory submissions
For long-term adaptability, consider registering Protein A more generically—e.g., as a “Protein A matrix”—to support seamless transitions from resin to membrane formats.
Frequently Asked Questions
Protein A chromatography is the most common type of affinity chromatography used in biopharmaceutical manufacturing. It is primarily used for the purification of antibodies, especially monoclonal antibodies. Protein A is a bacterial protein that binds specifically to the Fc region of immunoglobulins, particularly IgGs. This property makes it an effective tool for isolating antibodies from complex mixtures, such as cell culture supernatants or serum, due to its high specificity and efficiency in binding to the Fc region. The process involves passing the mixture through a stationary phase with immobilized Protein A, which selectively binds the antibodies, allowing other components to be washed away. Subsequently, the antibodies can be eluted in a purified form, usually by lowering the pH of the mobile phase.
Resins and membrranes are two types of Protein A chromatography media. Both are used for the purification of antibodies, but they differ in their material structure, and they are best suited for different circumstances:
- Protein A membranes:
- Structure: Protein A membranes are typically flat sheets or spiral wound modules integrated into a hard plastic housing. Protein A is immobilized on the surface of these membranes. The prevalent mass transport mechanism is convection, responsible for actively transporting the target molecule to the binding sites. Sartobind® Rapid A is a Protein A-modified agarose-based chromatography membrane.
- Application: Protein A membranes can be operated at a higher flow rate because shorter residence times are required to achieve an acceptable binding capacity (seconds vs. minutes). This makes them a great match for situations where time, productivity, and | or flexibility are the priority, like process development, early clinical phases, or low-yearly-demand commercial batches.
- Advantage: Faster processing times allow purification of the same amount of mAb in a shorter time frame with smaller bed volumes, resulting in better use of the membrane's overall lifetime compared to resins. Protein A membranes also do not require extensive preparation steps (like column packing and validation), reducing the overall processing suite and storage footprint.
- Protein A Resins:
- Structure: Protein A resins consist of beads made from polymeric materials like agarose or other polymers, with Protein A immobilized mainly within their porous structure. The driving mass transport mechanism is diffusion. These beads are packed into columns.
- Application: Resins are the most widespread type of Protein A chromatography media. They can handle larger volumes compared to membranes, which makes them an economical choice for late-clinical phase and commercial manufacturing of mAbs, especially those with high yearly demands.
Advantage: Despite requiring much longer residence times, Protein A resins offer high binding capacity and chemical stability, significantly extending their lifetime.
The capture step is the most effective but cost-intensive unit operation in the purification train of mAbs. Removing any bottlenecks associated with Protein A chromatography steps is essential to control manufacturing costs while keeping the required quality level. This can be approached from several aspects of the process, for example:
- Column design and scale: Carefully dimension the Protein A step to fit the expected demand and throughput, considering the type of Protein A chromatography media and the intended application. Scale-up, parallelization, or continuous processing are some of the options to increase capacity and throughput.
- Protein A media selection: Balance the required capacity and throughput to ensure that most of the lifetime of the media is used.
- Process optimization: Optimize loading, washing, elution, and cleaning conditions to maximize efficiency. This includes adjusting flow rates, buffer compositions, pH levels, or other process parameters.
- Feed stream treatment: Protect the Protein A chromatography media by optimizing USP conditions and filtering the feed stream.
- Automation: Implement automated systems to streamline the process, reduce manual intervention, and increase consistency.
Sartobind® Rapid A is also available in small formats, ideal for initial testing. These can be purchased through the Sartorius eShop. If you require more information, please contact your local sales representative.
