Personalized medicine

As per 2019, BioConnection offers new cleanrooms for Advanced Therapy Medicinal Products (ATMP) manufacturing, including Personalized Medicines and cell-based therapies (BSL2 classification). These areas can also be rented for (short) terms to, for example, your complex production process.

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