Case Studies

Development Projects

• Process development and scale up of highly potent API for phase I/II

• Customer – Big Pharma Company
• Information Available
  • Medicinal chemistry process
• Deliverables
  • 500 g & 2 Kg
• Critical Issues
  • Availability & lead time of key starting materia
  • Tightened heavy metal (Cu & B) specifications
  • Chromatographic purification in a cytotoxic stage
• Work Done & Improvements
  • In-house preparation of key starting material
  • Improved process to control heavy metals
  • Replacement of chromatography with robust crystallization method
  • Solvent screening
  • Metastable zone width determination
• Results
  • Repeat order for 5 Kg
• Working on more than 80 projects with this Big Pharma customer
  

• Scale-up to manufacture large kilo scale intermediates for compound entering Ph 2

• Customer – Scandinavian Company
• Information Available
  • Technical Package
• Deliverables
  • Process Development and scale up of building blocks – 34 steps
  • Improved scalable process
• Critical Issues
  • Low Yields
  • Impurity profile
  • Tightened specifications to meet DMF specifications
• Work Done & Improvements
  • Several projects completed over the last 5 years
  • Robust process development for several fragments
• Results
  • Costs brought down by 60% due to process modifications
    

• Dosage project (IR to MR) for Phase 3 needs

US pharma company provided their IR formulation and wanted MR form with 3 different extended release profiles

• CPS provided not only alternate dosage form more amenable to the customer’s long term strategy, but also using FBC technology
• Preliminary GMP supplies for Clinical study in several countries completed. Scale-up and registration batches in progress
• We are also providing Regulatory services for the filings
• One more molecule for complete development of MR dosage of different profiles awarded