Research & Development

Research & Development

Research & Development

  • Route scouting
  • Reference standards and impurities qualification
  • Preliminary stability studies
  • Solid state characterization
  • Quality by Design (QbD) approach
  • ICH stability studies
  • Technology Transfer
  • Hazardous reactions
  • High Potent Compounds (HPAPI)
  • Sterilized APIs*
  • Closed loop systems OEB6 (OEL < 0.2 µg/m³ ) compliant
  • Chromatography column

*Outsourced services

Route Selection & Process Chemistry

  • Route selection
  • Process development
  • QbD driven process development
  • Integration of process safety and containment from development stage
  • Determination of critical process parameters (CPP)
  • Identification of critical quality attributes (CQA)
  • Kilolab and small scale manufacturing
  • Hazardous reaction capability: fluorination, cryogenic (–80 °C) high pressure hydrogenation up to 50 bar
  • Early containment assessment

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