Fill and Finish capacities at BioConnection

Small-scale filling line + 3 m² freeze dryer

Compounding volumes: 2L - 50L

Indicative maximum batch sizes (*)

Vial size Liquid product Freeze dried product
2 RDIN 17,200 11,000
6 RDIN 12,500 5,700
10 RDIN 10,000 4,800
20 RDIN 5,000 3,000
25 RDIN 4,000 3,000
50 RDIN 2,000 1,400

(*) Actual batch size depends on requested scale of production and filling volume/vial. Examples are based on a 50% filling volume/vial (e.g. 25 ml fill in a 50 RDIN vial, etc.)

Large-scale filling line + 10 m² freeze dryer

Compounding volumes: up to 500L+

Indicative maximum batch sizes (*)

Vial size Liquid product Freeze dried product
2 RDIN 57,000 – 150,000 44,900
6 RDIN 57,000 – 150,000 23,200
10 RDIN 50,000 – 150,000 19,600
20 RDIN 25,000 – 100,000 12,600
25 RDIN 20,000 – 80,000 12,600
50 RDIN 10,000 – 40,000 6,800

(*) Actual batch size depends on requested scale of production and filling volume/vial. Examples are based on a 50% filling volume/vial (e.g. 25 ml fill in a 50 RDIN vial, etc.)

Summary of our services

Drug product development

  • Formulation development
  • Process and analytical development & validation
  • Lyo-cycle development and/or optimization
  • Transfer and scale-up to clinic
  • Transfer and scale-up to market

Freeze drying

  • Shelf areas ranging from 3 m² up to 10 m²

Clinical trial material services

  • Labeling
  • Clinical trial packaging
  • QP release
  • Storage

Fill and Finish

  • Batch sizes: from 1 unit up to 150,000 units per batch
  • Clinical and commercial scale
  • Automated fill and hand fill
  • Aseptic filling
  • Vials: from 2 RDIN up to 50 RDIN
  • Syringes: from 0.5 ml up to 10 ml
  • Other primary packs: via handfill
  • Terminal sterilization