Genovior provides professional services in (a) process development, (b) scale up, and (c) small scale production for synthesizing peptide API and small molecule drugs (SMDs) in uses of clinical trials and regulatory filing. Our APIs are manufactured in compliance with cGMP guidelines.
Peptide APIs Synthesis Platform
- Scale up studies
  • Flexible quantities - from milligrams, grams to kilograms
  • High-quality purification by LC

- Synthesis technologies
  • Combination of solid phase and liquid phase synthesis
  • Modified peptides: -NH2 modifications (acetylation, biotinylation, Malonylation, etc.), -CO2H & -OH modifications (amidation, esterification, oxidation, reduction, etc.), side chain modifications (phosphorylation, actylation, biotinylation, palmitoylation, etc.), structural modifications (N-methylation, cyclization, etc.)

- Process validation
  • Process design, process qualification, continued process verification

- Chemistry, Manufacturing and Control (CMC)
- Regulatory supports
Small Molecule Drugs (SMDs) Synthesis Platform
- Molecule structural and reaction route design
- Scale-up and process optimization of synthesis protocol
- Development of new process methodologies for customer needs
- Developing efficient and practical purification method
- Cost-efficient synthesis methods
Manufacturing Facilities
- High-performance liquid chromatography - HPLC
- Evaporative light scattering detector - ELSD
- Preparative Low and Medium Pressure Liquid Chromatography (Ion exchange facility), high flow rate
- Preparative HPLC systems (RPLC), high flow rate
- Reactors: 50L ~ 100L.
- Peptide synthesizer