ScalePrep Kits For Process Development And Optimization

ScalePrep Kits are used to develop an optimized robust chiral separation method for target enantiomer that can be scaled up for manufacturing to multi-kilo quantities.

Precision of the methods used for process development are critical as time and material required to attain target purity and yield are magnified as the production requirements increase. Small improvements in the process can have disproportionately positive impacts on costs.

ScalePrep provides a stepwise solution to achieve optimum separation performance. Starting with a screening process, it identifies 2-3 candidate separation approaches and identifies which approach offers fastest end-results. Selected approach is then optimized through Optimize kits to ensure highest purity and yield is achieved through minimum number of steps. The optimization factors are:

ScalePrep includes:

  1. Set of 4 Screen Kits
  2. 3 Purify Kits (for 3 selected candidates)
  3. One or more Optimize Kits (to be delivered by ChiroSolve) after identifying ideal separation parameters
  4. Complete step-by-step procedure that describes the work

Key features:

  • 4 Screen Kits offer exhaustive screening to identify 3 best separation conditions
  • 3 Purify Kits define detailed optimum separation process that yields highest amount of purified enantiomer through minimum number of crystallization steps
  • Optimize Kit(s) fine-tune the separation process using above listed optimization factors
  • Results within 2 weeks

Key benefits:

  • Chiral separation method optimization achieved within days rather than months by systematically converging on optimization parameters
  • Focused efforts addressing scalability dynamics in terms of robustness, number of steps involved, energy efficiency and process safety
  • Establish an elaborate step-by-step scalable procedure for separation through iterative crystallizations required to achieve required purity
  • Produce multi-gram quantities of enantiomer for use in preclinical testing
  • Provide a design basis for enantiomer manufacturing
  • Works against any racemate (acid, base, alcohol, aldehyde, ketone, amino acid, racemate with multiple chiral centers)

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