Adapted from a presentation by Joerg Ahlgrimm, CEO of SK pharmteco at CPHI Worldwide 2024 in Milan
Simulated Moving Bed (SMB) is a continuous chromatographic separation process designed to optimize the purification of binary-like separations, such as enantiomers, diastereomers, or structurally related impurities. Unlike batch chromatography, SMB operates continuously, offering cost savings, enhanced efficiency, and environmental benefits.
SK pharmteco successfully implemented an SMB chromatography process to produce 1,635 kg/week of a specific API at a remarkable 99.3% chiral purity. This process utilized 800,000 liters of solvent per week, but with a continuous solvent recycling rate of 99.6%, the net solvent requirement was significantly reduced to just 3,200 liters/week. This reduction in solvent consumption not only decreases procurement costs but also minimizes waste generation, aligning with the principles of Green Chemistry.
The SMB process boasts a Process Mass Intensity (PMI) of 1.9, a substantial improvement over the traditional resolution method’s PMI of 30. This significantly lower PMI underscores the environmental benefits and reduced resource consumption associated with SMB technology.
In collaboration with our customers, we have successfully recycled solvents to meet or exceed the specifications of virgin solvents. This achievement required close cooperation with regulatory agencies to obtain approval for integrating recycled solvents into the manufacturing process.
Customer Benefits
The implementation of this SMB process offers numerous advantages to our customers:
- Higher Purity and Quality: Producing APIs with 99.3% chiral purity ensures the delivery of high-quality, consistent products, crucial for regulatory compliance and therapeutic efficacy.
- Cost Efficiency: The continuous solvent recycling significantly reduces the need for new solvent procurement, leading to substantial cost savings in materials and waste disposal.
- Sustainability: By adopting highly sustainable and green technology, customers benefit from reduced environmental impact, aligning with increasing global ESG (Environmental, Social, and Governance) requirements.
- Reduced Resource Consumption: The process’s low net solvent requirement minimizes supply chain risks and ensures efficient resource utilization.
- Lower Process Mass Intensity (PMI): The significantly lower PMI compared to traditional methods contributes to lower production costs and reduced environmental impact.
SK pharmteco combines peerless SMB technical expertise with decades of experience to deliver innovative solutions tailored to our customers’ needs. Our track record of excellence in separation and purification positions us as a trusted partner for pharmaceutical companies seeking efficiency, scalability, and quality at every stage of development. Discover how SMB can revolutionize your purification processes. Contact us today to discuss your project needs and learn how we can deliver unmatched efficiency, scalability, and sustainability.
Contact us to explore our SMB solutions.