What are the Key Advantages of Large-scale Chiral Chromatography?

Speed

Development time for a chiral chromatography method is very short compared to most of the alternatives. Less than one year development, from laboratory feasibility study to the multi-tons production, has been achieved by Novasep. Chiral chromatography is the best method to help you reduce time to market for enantiomerically pure API's.

Security

Chromatography reliably 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 so much security and predictability from a simple test on a few milligrams.

Versatility

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.

Environment

At a laboratory scale, Supersep™ units with its 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, Varicol® systems, with automated solvent recycling will recycle more than 99% of organic solvents. You contribute to preserve the environment with improved economics.

Robustness

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.

Cost Effectiveness

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 crystallization or asymmetric synthesis.

Simplicity

Continuous chromatography appears to be a relatively complex art. However Novasep's teams are experienced and 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 stand 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.

Out-Sourcing Options

If you don't feel comfortable with large-scale chiral chromatography at your facility, Novasep offers process development, and contract 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.