Preparative chromatography is often seen as a solvent and time consuming method that is both inconvenient and expensive. Although that may have been true a few decades ago, it is no longer the case. Preparative chiral chromatography is now perfectly adapted to development and commercial scales with fully automated equipment enabling fast and cost-effective separations with little impact on the environment.
Development time for a chiral chromatography method is very short compared to most alternatives. Development in less than one year, from laboratory feasibility study to multi-ton production, has been achieved by Novasep. Chiral chromatography is one of the best methods to help you reduce time to market for enantiomerically pure APIs.
Chromatography allows reliable scale-up processes from analytical scale to multi-ton production. Novasep can predict the resolution cost of operations at any scale from the results of a simple development program available in less than three months. No alternative methods can afford as much security and predictability from a simple test on a few milligrams.
Every racemic mixture can potentially be resolved by chiral chromatography. Therefore, the equipment can be used for multiple chiral compounds, leading to a rapid return on investment. Moreover, the adaptability of the equipment allows you scale up or down in production, depending on market demands.
At a laboratory scale, Prochrom Supersep units with their integrated recycling technology minimize your consumption of CO2 eluent and organic co-solvents. You gain the speed and cost-efficiency of supercritical processes for early development projects while reducing the impact on the environment, compared to batch chemistry.
At industrial scale, Prochrom Varicol systems, with automated solvent recycling will recycle more than 99% of organic solvents. You contribute to preserving the environment with improved economics.
Large-scale continuous chiral chromatography provides high optical purity with reproducible impurity profiles and excellent yields. This enables you to meet the most stringent regulatory standards in cGMP compliant systems.
Low solvent consumption through recycling and continuous operations, combined with a generally shorter chemical route to the targeted API, often allows you to reduce the cost of goods. A growing number of APIs are obtained using chromatography resolution as a commercial route. The costs incurred in producing with this technology may be lower than diastereomeric salt formation or even asymmetric synthesis as it was the case for some of the APIs produced by chiral chromatography.
Continuous chromatography appears to be a relatively complex art. However, our team of experts will make your work with a chromatographic system fast, easy and more efficient. We have successfully qualified systems and stood beside our customers through multiple FDA and other regulatory inspections of their operations. We provide quality documentation and training for your operators and technical staff. Our customer service team stands by you for replacement parts, re-qualification, upgrades and maintenance of your equipment. Our R&D department is experienced in developing and troubleshooting pharmaceutical purification processes.
If you don't feel comfortable with large-scale chiral chromatography at your facility, we offer process development and custom purification services in our FDA-inspected facilities. We are ready to provide any quantity from kilograms to multi-tons for your drug development or commercial needs.
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