Case Study III : Process development and supply of NCE

Project Scope

To optimize the customer’s process leading to supply of NCE for toxicology study and phase-I clinical trials


Customer

Mid Pharma company, EU


Deliverables

  • Development & Optimization of Process (done by customer at very small scale)
  • Lab scale Process validation
  • Analytical method development
  • 3 X 25 g of samples to customer for evaluation
  • Scale-up to provide 25.0 – 30.0 Kg of material for toxicology studies and phase-I clinical trials
  • Stability studies as per ICH for 2 years


Value addition

  • Identification and removal of unknown impurity
  • HPLC linear gradient method developed for purity determination (original method was using different gradient conditions for different stages)
  • Execution time reduction by making Initial two stages telescopic (original process involved isolation of these stages)
  • Yield improvement in intermediate stage for 65% to 85%


Customer Delight

  • Project delivered with 30.0 Kg material in 5 months against the agreed timelines of 6 months





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