Handfill

Since 2019 BioConnection also offers access to manual filling machine for small scale batches and/or custom size vials within our state-of-the-art GMP manufacturing facilities. 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 75,000 units per batch
  • Clinical and commercial scale
  • Automated fill and hand fill
  • Aseptic filling
  • Vials: from 2 RDIN up to 25 RDIN
  • Syringes: from 0.5 ml up to 10 ml
  • Other primary packs: via handfill
  • Terminal sterilization