ScalePrep (Duration: 2 weeks)

ScalePrep Services are designed to develop an optimized, cost-effective and energy-saving chiral separation method that can be scaled up to kilo quantities in support of manufacturing readiness.The service includes:

Screening: Using 4 Chirosolve kits, the racemate is screened against 384 combination of resolving agents/solvents to get a comprehensive list of chiral separation candidates; from which the best three(3) candidates are selected. Finally, if the derivatives of the selected resolving agents are available, we also check if a specific derivative offers further optimization.

Purification: Using three(3) ChiroSolve Purify kits, for each of the three selected resolving agent and solvent combinations, detailed method to develop the enantiomer with target (or best) purity is defined using series of re-crystallization steps. Method offering highest yield and purity with minimum number of steps is selected.

Optimization: This phase of the service optimizes the method selected during "Purification". It identifies the ideal ratio between racemate and reagent; ideal concentration of solvent that offers highest yield and purity. It also explores the energy efficiency parameters that can reduce manufacturing cost. This work is done through the use of Chirosolve's Optimize kits; which contain different concentration of resolving agent and solvent in each row/column; providing 96 different conditions under which diastereomeric salt can form.

Note: All our services are considered “research projects” and we cannot guarantee that the enantiomeric purity will be achieved. Work is done under best-effort basis.

Performance

  • Perform the screening (described above) to identify separation candidates
  • Use the best 3 candidates to identify which combination offers fastest route for enantiomer delivery
  • Optimize the process to identify what racemate to reagent ratio and concentration of solvent offers maximum yield through minimum steps
  • Deliver step-by-step, robust and optimum separation method within two weeks

Key Benefits

  • Reduce method development time dramatically from months to days by systematically converging on optimal separation and process parameters
  • Understand the scalability dynamics in terms of robustness, number of steps involved, energy efficiency and process safety
  • Create a complete step-by-step procedures for separation and iterative crystallizations required attaining product specifications
  • Produce kilo-lab quantities of enantiomers for using in preclinical and clinical testing
  • Provide a design basis for enantiomer manufacturing
  • Establish an IP foundation

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