Clinical fill and finish
BioConnection offers clinical fill and finish for your products. Our capabilities include liquid fill or lyophilization intended for vials or prefilled syringes. Fill and finish is the core of our company!
Clinical scale fill and finish
BioConnection fulfills the needs of innovative (bio)pharmaceutical companies by offering flexible state of the art development and GMP compliant manufacturing services for sterile Drug Products, for both clinical trial and commercial scale manufacturing.
The cornerstone for our offering is our manufacturing plant in Oss. This plant complies with EMA and FDA regulations. Here, we can provide you with the automated fill of clinical-grade cGMP products in vials and syringes, both liquid and freeze-dried. We offer handfill of vials and in almost any other container format, leading to a very flexible approach. And, due to the efforts of BioConnection, we provide a seamless transfer from the handfill unit to the automated unit.
Small-scale filling line + 3 m² freeze dryer
Compounding volumes: 2L - 50L
Indicative maximum batch sizes (*)
|Vial size||Liquid product||Freeze dried product|
(*) 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.)
Time to scale up?
If your product is successful and demands larger-scale production, we can facilitate your commercial launch on our large-scale filling line. This benefits you to scale up to commercial production in time for the market, all within the same building and while eliminating transfer costs.
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
- Shelf areas ranging from 3 m² up to 10 m²
Clinical trial material services
- Clinical trial packaging
- QP release
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