Process R&D Data Centric Process Design

Data Centric Process Design

At Asymchem we implement Data-Centric Process Design to advance synthetic routes into commercially viable manufacturing processes. Leveraging our advanced technology and extensive experience, our matrix teams take a holistic approach, designing processes that meet the highest standards in line with established SELECT criteria.
Data Centric Process Design
01
Planning
  • Engage in a detailed discussion with the client to listen and clarify the scope.
  • Identify the key drivers specific to the client and the target compound that will influence decision-making.
  • Detailed assessment of existing knowledge, process, analytical methods and impurity landscape.
  • Sustainability metrics are initially collected as part of a benchmarking exercise.
  • Co-development of a process's R&D plan with key milestones.
02
Fundamental Data Generation
  • Utilizing our state-of-the-art high throughput experimentation platforms, core data of solubility, reaction screening, kinetic data, liquid-liquid extraction screening and solid form screening can be rapidly generated.
03
Process Design
  • The fundamental data allows our experienced scientific experts to brainstorm vision processes designing from the ground up.
  • The matrix team ensures subject matter expert input from a process's genesis.
  • Practical evaluation then enables further refinement of the designed process guided by the data and client's drivers.
  • Integrated Process Safety specialists provide guidance and support at all stages.
  • Crystallization SME’s design the final isolation to ensure the target compound achieves the desired physical attributes. 
  • Concomitant development of the process and analytical methods in a harmonized approach to build towards the control strategy.
04
Process Confirmation
  • Critical assessment of the lead process(es) to ensure suitability for commercial manufacture and identify any potential risks early.
  • Robustness assessment of key transformations (inc. DoE) to ensure a suitable operating space.
  • Engineering and scale-up assessment, of steps through a combination of practical and in silico approaches.
  • Stability and hold-point assessment to demonstrate robustness of key unit operations and provide manufacturing flexibility,
  • A small-scale demonstration of the final process to author the technical package/process description.
  • Impurity genealogy mapping facilitated by the partnership in process and method design.
  • Thorough documentation of the development chronology including factors that drove decision making.
Output: The Optimum Process For Commercial Manufacture
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