Handfill
Since 2019 BioConnection also offers access to a manual filling machine for small scale batches in standard vial formats, bottles, eyedrops, nasal sprays, etcetera. The actual fill is performed in a grade A cabinet, situated in a Grade B environment. All product contact components are disposable or dedicated, allowing us to work with a wide range of different products. Manufacturing on this line can also be completed with and a broad range of BioConnection support services.
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