The landscape of protein purification is undergoing a transformative shift with the advent of continuous countercurrent tangential chromatography (CCTC). This innovative approach offers a scalable, disposable, and cost-effective alternative to traditional column chromatography, which has long been the standard in the industry. As advancements in cell-culture technology yield more efficient therapeutic protein production, the challenges of downstream processing intensify, often leading to bottlenecks in purification. CCTC emerges as a powerful solution to these persistent issues.
Limitations of Traditional Methods
Conventional batch-column chromatography presents several drawbacks, primarily inefficiency and high costs. Oleg Shinkazh, CEO of Chromatan Corporation, emphasizes that these challenges are particularly acute in clinical manufacturing. The underutilization of expensive resins, like Protein A, often results in only a fraction of their potential lifespan being realized. Furthermore, Kent Smeltz, President of ASI, highlights a significant gap in the adoption of single-use systems for protein purification, which have not yet been economically optimized for such operations.
The CCTC Advantage
Continuous countercurrent tangential chromatography integrates the principles of chromatography with continuous processing techniques, including liquid-liquid extraction and tangential flow filtration. This combination has led to the development of a “true moving bed” technology, eliminating the need for conventional columns. The Evopure system, co-developed by Chromatan and ASI, exemplifies this innovation, retaining the essential interactions and buffer chemistry of traditional methods while utilizing a flow path designed specifically for single-use applications.
In the Evopure system, chromatography resin is not confined to a fixed-bed column but is instead suspended in a slurry that flows through the system, akin to a conveyor belt. This design allows for simultaneous chromatographic operations—binding, washing, elution, and stripping—while employing a countercurrent flow of buffers. This setup promotes high-resolution separations and reduces the buffer volume required for effective protein purification, addressing both efficiency and cost concerns.
Economic and Operational Benefits
The Evopure system significantly enhances the efficiency and cost-effectiveness of protein purification. With throughput increased five- to ten-fold compared to traditional column systems, high resin cycling within a single batch becomes feasible. This scalability enables practical single-use capture processes, potentially reducing costs by up to 65%. Shinkazh notes that the elimination of column packing, qualification, cleaning, and resin storage further streamlines the purification process, providing manufacturers with greater flexibility.
The partnership between ASI and Chromatan, established in April 2013, is pivotal for bringing this cutting-edge CCTC technology to market. By combining their expertise in development, sales, and manufacturing, both companies aim to finalize and launch the Evopure system, promising to transform the protein purification landscape.
Collaborative Innovation
With ASI’s strong capabilities in turnkey single-use solutions and Chromatan’s expertise in CCTC technology, the partnership is well-positioned to meet the evolving demands of the industry. ASI’s commitment to differentiating single-use technologies aligns seamlessly with the innovative spirit of CCTC. Together, they aim to introduce a solution that not only addresses current challenges but also anticipates future needs.
The collaborative effort focuses on technical sales and customer support handled by Chromatan while ASI manages hardware and single-use component manufacturing. Jointly designed commercial systems will enhance market reach and customer service, ensuring that the benefits of CCTC are effectively communicated and implemented.
Targeting Key Applications
The initial application of the Evopure system targets protein A capture chromatography, especially for monoclonal antibodies, where the potential for immediate cost savings and process acceleration is greatest. This strategic focus underscores the technology’s capability to resolve specific industry pain points while laying the groundwork for broader applications in ion-exchange chromatography and other specialized areas.
Future Directions
Both ASI and Chromatan view their partnership as a long-term commitment to innovation, anticipating a shift towards flexible, single-use facilities in the bioprocessing sector. As the demand for efficient and cost-effective protein purification solutions grows, the CCTC technology is poised to play a critical role in meeting these requirements.
As the industry evolves, the integration of continuous chromatography into standard practices signifies a pivotal change in how proteins are purified. The collaboration between ASI and Chromatan will not only enhance operational efficiency but also drive down costs for manufacturers, ultimately benefiting the broader pharmaceutical landscape.
Key Takeaways
- Continuous countercurrent tangential chromatography (CCTC) offers a scalable and cost-effective alternative to traditional batch-column chromatography.
- The Evopure system eliminates the inefficiencies associated with column packing and cleaning, simplifying the purification process.
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CCTC technology can increase throughput by 5 to 10 times, enabling significant cost reductions in protein purification.
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The partnership between ASI and Chromatan aims to revolutionize protein purification, focusing initially on monoclonal antibody applications.
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This innovative approach aligns with the industry’s shift towards flexible, single-use manufacturing solutions.
In conclusion, the emergence of single-use continuous chromatography marks a significant advancement in protein purification. By addressing longstanding inefficiencies and adapting to modern manufacturing needs, CCTC technology stands to redefine practices in bioprocessing and contribute to the successful development of therapeutic proteins.
Source: www.pharmtech.com