Process Development & Manufacturing

Whatever your needs, from preclinical development through to development of manufacturing of the active pharmaceutical ingredient (API process development) for clinical trials to development of your API manufacturing process, Ricerca offers you flexible access to a broad spectrum of manufacturing process development, pharmaceutical process development and manufacturing expertise. This expertise includes specialist scientists with experience in development manufacturing, process development chemistry, pharma process development, manufacturing route and manufacturing and development determination. Our experts specialize in establishing process of manufacture, manufacturing development, establishing your active pharmaceutical ingredient manufacturing process, and chemical manufacturing process. Our three-decades of experience also includes process chemistry and development, analytical chemistry, and engineering capabilities. We are proficient in a diverse range of organic chemical reactions and excel at combining them into a safe, reliable, efficient, and cost-effective manufacturing process for your APIs, intermediates, regulatory starting materials and performance chemicals. All capabilities are ideal for establish also your commercial manufacturing process.

Ricerca's process development and manufacturing services include:


Process chemistry

  • Route discovery and definition
  • Process improvement and optimization
  • Robustness and process limits testing

Process development and engineering

  • Process scale up and demonstration
  • Process validation
  • Engineering data acquisition
  • Technology transfer to commercial scale

Manufacturing

  • Preparation of active pharmaceutical ingredients (APIs) under cGMP controls
  • Preparation of intermediates, regulatory starting materials and performance chemicals
  • Multi-kilogram to multi-ton amounts (process-dependent)
  • Manufacturing in support of pre-clinical, clinical and commercial requirements

Process Development & Manufacturing Equipment

  • Pilot Plant Facility
  • – Reactor volumns to 3,000 liters
    – Solid/liquid separation systems
    – Liquid/liquid separation systems
    – Drying systems
    – Large flash chromatography systems
    – Isolation systems/facilities
  • cGMP Kilo Labs
  • – HEPA-filtered air system
    – Processing scale to 50 liters
    – Dedicated single project use