Product development & manufacturing

Capabilities for Dosage Forms

• Preclinical profiling
  
  
• Pre-formulation: physical pharmacy, solid state characterization, salt selection, polymorph screening
  
  
• Formulation, process development, clinical/commercial manufacturing and supply for sterile and oral solid dosage forms (conventional and non-conventional technologies)
  
  
• Scale-up and Technology Transfer: batch size from few mL/200 g to 250 L/50 Kg for sterile and oral solid products respectively
  
  
• Flexibility/Versatility for Market-place productions

High Containment

• Ready-to-use solutions, freeze-dried forms
  
• Barrier isolation technology (cytotoxics and hazardous drugs, e.g., highly potent biotech products)
  
• Glove-boxes for weighing and compounding operations
  
• Exterior decontamination/washing/drying of sealed vials

• Glove-boxes and double-door airtight transfer of materials for weighing, compounding, mixing, capsule filling and packaging operations
  
• Automatic capsule filling machine enclosed in a glove-box, microprocessor-driven for checking individual capsule weight
  
• Special area for highly potent and toxic drugs
  
  • Tablets, capsules (plain, coated)
    
  • Special operational procedures, operator garments/respiratory equipment, bag-in/bag-out HEPA filters
    
• Solution/dispersion preparation
  
• Automatic liquid/semi-solid capsule filling and sealing line ("wet" system to prevent dusty environment)

• Optimization studies to select/justify formula & manufacturing process
  
• Pre-clinical and Clinical manufacturing
  
• Blinding of drug, comparator and placebos
  
• Oral solid dose and semi-solid products
  
  • Tablets as direct compression, wet and dry granulation
    
  • Hard Filled Capsules: simple mixing, wet and dry granulation, liquid and semisolid. Automatic filling
    
  • Tablets, aqueous film and sugar coating
    
• Sterile products (aseptic processing and terminal sterilization)
  
• Bulk solutions and suspensions (250 L) aseptically produced and terminally sterilized in vials
  
• Automated filling line: 3-100 mL vials size; filling rate: 3,000-5,000 vial/hr; microdosing
  
• Freeze-dried vials (lab scale, industrial scale 4sqm)
  
• Scale up and Technology Transfer

Formulation Development & Manufacturing