Case Study I : Process Accommodation & Contract Manufacturing

Project Scope

To accommodate customer’s exclusive process for contract manufacturing


Customer

Mid size company, EU


Deliverables

  • Lab familiarization of process owned by customer
  • 3 x 100 g of sample for evaluation by customer
  • Pilot plant scale up
  • Process Validation at plant scale for supplying 20 kg to 30 kg
  • Stability-long term, DMF document compilation support


Value addition

  • Optimization of Residual solvent levels as per ICH guidelines
  • Evaluation & standardization of Polymorph
  • Identification & removal of unknown impurity


Customer Delight

  • Project delivered within agreed timelines of 16 months
  • Long term supply contract signed
  • New Business collaboration initiated





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