What we do

BIO Fill & Finish

SINGLE-USE SYSTEM

  • Filtration
  • Bulk handling
  • Filling
  • No cross-contamination

     

GENTLE HANDLING

  • Paddle mixer
  • Peristaltic pumps
  • Careful freezing/thawing

     

FREEZE-DRYING

  • Organic solvents
  • Dual cooling system (liquid Nitrogen)
  • Automatic loading/unloading




     

LOW HOLD-UP VOLUMES

  • Less than 800 ml





     

BIOMOLECULES

  • Antibodies
  • ADCs
  • Peptides, proteins
  • Oligonucleotides

     

DIFFICULT FORMULATIONS

  • Temperature control (-70°C to + 30°C)
  • Oxygen sensitive
  • Light protection
  • Dispersion systems
  • Organic solvents

     

ISOLATOR FILLING

  • Low residual peroxide (<0.1 ppm)
  • VHP decontamination
  • Weighing isolator
  • Filling isolator

     

ACTIVES

  • Cytotoxic, cytostatic
  • Non-cytotoxic
  • High potent (OEB 4, OEB 5)


     

FDA

  • MRA EU-US covered