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GMP Manufacturing

BioConnection offers access to state-of-the-art GMP manufacturing facilities and a broad range of support services. BioConnection operates from its proprietary FDA and EMA approved facility in Oss, the Netherlands. From this facility, we can provide you with clinical scale manufacturing in a wide variety of formats and techniques, including freeze-drying. Besides our expertise in development and manufacturing of clinical trial medication, we are your partner in proven track-record for global commercial manufacturing for small indications and orphan drugs. This is a unique proposition where you can rely on our experienced team and AAA-class facility.

Summary of our services

Freeze drying

Shelf areas ranging from 3 m² up to 10 m²

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

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

Clinical trial material services

  • Labeling
  • Clinical trial packaging
  • QP release
  • Storage