R&D

Research & Development

ZaCh System’s R&D resources are supported by cutting edge technologies, including solid state control during crystallization (FBRM PAT) and powder characterization (PSD, DSC, TGA, RAMAN, FT-IR, flowability).

 

PROCESS DEVELOPMENT CAPABILITIES

  • Development of highly complex synthetic methodologies (up to 12-15 steps)
  • Tech transfer and process optimization for large scale GMP manufacture (kg to MTs): NOR/PAR determination, critical parameters, QbD using DoE approach
  • Supply chain securing through new RM suppliers qualification
  • Process troubleshooting through downscaling
  • Solid state engineering (traditional or scale down approach using customized glassware reactors mimicking industrial equipment; lab-scale filter-dryer; lab-scale mill; lab-scale spray-dryer; FTIR/RAMAN/FBRM  PAT; DoE approach)
  • Continuous flow and microtechnologies (limited to Ozonolysis)
  • Handling of  High Potent APIs (OEB5, OEL>0.1mg/m3)
  • PAT: In-situ FTIR, Raman (ATEX), FBRM (ATEX), turbidimetry
  • 1-5 kg batch manufacturing under GMP in the Macrolab (15/30 lt glass reactor, -80°C/160°C; 1 filter-dryer)

PROCESS SAFETY AND THERMAL ANALYSIS

  • Process safety assessment (DSC, low/mid-high temp RC, ARC; TGA) – Risk analysis

ANALYTICAL DEVELOPMENT AND STRUCTURAL CHARACTERIZATION

  • Analytical development (UV/CAD/RID-HPLC, GC, HS-GC)
  • Structural characterization (GC-MS, HPLC-MS, NMR, IR)
  • Solid state/powder characterization (microscopy, XRPD, SEM, DSC, IR, RAMAN, PSD, flowability properties)