Continuous countercurrent tangential chromatography (CCTC) is emerging as a groundbreaking alternative to traditional batch column chromatography, providing a scalable and cost-effective solution for protein purification. As biopharmaceutical companies enhance their upstream processes, the demand for efficient and reliable downstream operations grows. CCTC addresses the persistent inefficiencies found in conventional methods, paving the way for a new era in protein manufacturing.
The Limitations of Traditional Batch Systems
In conventional column chromatography, batch operations often become a bottleneck due to their inherent inefficiencies. High capital and operational costs, coupled with lengthy process times, strain the production of therapeutic proteins. Oleg Shinkazh, CEO of Chromatan Corporation, highlights that costly resins, such as Protein A, are frequently underutilized, serving only 10% of their potential lifespan. This inefficiency is especially critical in clinical manufacturing, where every aspect of production must be optimized.
Moreover, the adoption of single-use systems in protein purification remains limited. Kent Smeltz, President of ASI, points out that purification operations lag behind other processes in terms of economic design for single-use applications, highlighting an urgent need for innovation.
The CCTC Approach: A New Paradigm
CCTC combines the principles of chromatography and continuous processing to create what is known as “true moving bed” technology. This system is distinct from simulated moving beds and facilitates large-scale, column-free capture purification of biologics. Initially developed by Chromatan and now in collaboration with ASI, the Evopure system maintains the effective interactions of column chromatography while introducing a flow path designed specifically for single-use operations.
Unlike conventional systems that rely on packed resin columns, the Evopure system employs a slurry of chromatography resin that flows continuously, emulating conveyor belt processing. This innovative approach allows for simultaneous chromatographic operations—binding, washing, elution, and stripping—while utilizing a countercurrent flow of buffers. The result is a high-resolution separation process that significantly reduces buffer consumption and enhances overall efficiency.
Cost Efficiency and Scalability
The introduction of the Evopure system addresses three crucial needs in the purification industry: cost reduction, sterility, and scalability. CCTC can increase throughput by 5 to 10 times compared to traditional column systems, making single-use capture not only feasible but also economically advantageous. Shinkazh estimates that this technology can save end users up to 65% in operational costs.
The elimination of traditional column constraints means that resources can be redirected from time-consuming tasks such as column packing, cleaning, and resin storage. This simplification of the purification process translates to greater flexibility in manufacturing operations, allowing companies to adapt more readily to market demands.
Collaboration for Innovation
In April 2013, ASI and Chromatan formed an exclusive partnership to enhance the development, marketing, and manufacturing of the CCTC technology. Each company brings unique expertise to the table, with ASI focused on turnkey single-use solutions and Chromatan specializing in technical sales and support. This collaboration aims to finalize the development of the Evopure system and bring it to market efficiently.
Smeltz emphasizes the importance of their partnership, stating that both companies are well-positioned to innovate and deliver a technology that sets itself apart from existing single-use solutions. This commitment to quality and customer-centric designs ensures that the needs of the biopharmaceutical industry are met effectively.
The Future of Protein Purification
The Evopure system is not limited to antibody purification alone. ASI and Chromatan plan to explore its potential for ion-exchange chromatography and other niche applications. By positioning themselves at the forefront of flexible, single-use facility trends, both companies are poised to redefine protein purification processes in bioprocessing.
Shinkazh expresses confidence in the chosen initial target—protein A capture chromatography for monoclonal antibodies—highlighting the immediate advantages in cost and efficiency. This focus exemplifies a strategic response to industry demands, ensuring that the technology meets the most pressing challenges faced by manufacturers.
Conclusion
Continuous countercurrent tangential chromatography represents a paradigm shift in protein purification, addressing the inefficiencies of traditional methods while embracing the future of biopharmaceutical manufacturing. The collaboration between ASI and Chromatan not only promises significant improvements in cost and efficiency but also sets the stage for ongoing innovation in the industry. As the bioprocessing landscape evolves, technologies like CCTC will undoubtedly play a pivotal role in shaping sustainable and effective production practices.
- CCTC offers a scalable, cost-effective alternative to traditional chromatography.
- The system eliminates the need for column packing and cleaning, enhancing operational efficiency.
- Initial applications focus on protein A capture chromatography for monoclonal antibodies.
- Future developments will explore other chromatography techniques and specialized applications.
- Collaboration between ASI and Chromatan aims to lead the way in innovative purification solutions.
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