Process Development and Supply of Clinical API

• Scope:
  Process Development and initial supply of 3X1Kg of API. 25 kg of GMP material after Process Optimization and 200 kg commercial production after plant validation.
• Complexity:

  Route involves Pyrophoric reagents and the KSM had stability issues leading to formation of Impurities during shipping. N-2 material has stability issues too. Controlling these impurities across the stages was very challenging.

• Quality & Yield:

  API was a chiral molecule & the final purity expectation was over 98% & 99% ee.

• Accomplishment:
  Shilpa made KSM inhouse and consumed immediately, Developed a process using N-2 Material crude directly for next conversion.

Shilpa delivered 3*1kg of API successfully, remaining work is on going.