Large scale filling capacities at BioConnection
Large scale filling line
Automated filling line in “tunnel” design
| Filling line (Groninger) | |
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in grade D cleanroom |
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in grade D cleanroom |
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grade A open RABS in grade B cleanroom |
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grade A open RABS in grade D cleanroom |
| Lyophilizer (HOF) | grade A open RABS in grade B cleanroom |
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EMA and US-FDA certified facility
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