To satisfy the demand for separation of racemic small molecules, we rapidly screen your molecules, free of charge, using our Chiral Stationary Phases in HPLC and SFC modes. Once an appropriate method is identified, we conduct enantioseparation of your racemate. We deliver purified enantiomers, meeting specifications of > 98% enantiomeric excess and > 85% yield, within ten days.
We designed small-scale separation services to provide you with rapid access to pure enantiomers in quantities ranging from a few milligrams to tens of grams.
Our small scale service helps accelerate the selection of compounds appropriate for further scale-up. The project scale ranges from a few milligrams up to gram quantities. When a particular molecule possessing the desired safety and efficacy characteristics is identified, we help proceed with the separation of this molecule at larger scales.
We rapidly screen your compound free of charge to identify the best separation method and conduct enantiomer resolution on a preparative scale using SFC or HPLC mode. We ensure that the purified products meet your specifications for enantiomeric purity and timely deliver.
For medium-scale separations, Chiral Technologies screens all available Chiral Stationary Phases with all possible mobile phase compositions to establish the best protocol for separating your racemic mixture. The method development strategy involves use of both HPLC and SFC modes. Once the separation is optimized, we carry out a loading study to determine the production rate and a stability study to ensure complete recovery of the purified enantiomers. From these studies, we estimate project costs.
Once the best method is found, we employ preparative HPLC, preparative SFC or SMB systems to conduct the separation at a scale required and deliver purified enantiomers, meeting specifications of > 98% enantiomeric excess and > 85% yield.
Global Capability for Enantiomer Production of Hundreds and Thousands of Kilograms
For large-scale projects, after we determine the best separation method possible to separate your material, we employ batch HPLC or SMB systems. Our preparative equipment global capabilities allow us to conduct separations of up to 100 kg of racemates, under cGMP if required.
Chiral Technologies also offers a SMB method development service. We screen a sample for potential large-scale production across all available CSPs to define the optimum conditions for SMB separations. If requested, we screen targeted compounds across Daicel’s proprietary CSP library. From this data, our specialists run a computer simulation to obtain an initial cost estimate to determine if the SMB process is economical. Following the simulation, our scientists confirm the cost estimate with a bench-top SMB unit. If required, the results are then used to establish the parameters for a production-scale SMB operation, the description of which becomes part of our technology transfer package.
For companies involved in the commercialization of single-enantiomer drugs, Chiral Technologies, together with Daicel, can assist in complete outsourcing of drug manufacturing processes. Our facility at the Daicel plant in Arai, Japan, is equipped to perform upstream or downstream chemical synthesis in addition to conducting metric-ton scale separations.
For more information on your preparative separation needs, contact your local office.
Chiral Technologies provides bulk polysaccharide-derived and other types of CSPs in kilogram quantities.