Case study: Recombinant blood factor for pre-clinical toxicology

Customer problem

  • Need for high performing CHO cell line producing recombinant human Factor VIII
  • Upstream/Downstream material production for pre-clinical Toxicology

Ingenza solution

  • Patented CHO cell line with productivity >10x highest reported for human FVIII
  • 350 vials at 500 IU/mL rhFVIII delivered, pre-clinical toxicology successfully completed
Host
  • CHO cell-line
  • Serum-free and adapted to suspension growth
Selection & USP
  • Codon optimisation, chaperone-enhanced, clonal selection
  • 3L scalable batch/perfusion process established
DSP
  • 3-step chromatographic DSP
  • Viral inactivation & removal (nanofiltration >85% recovery)
Pre-clinical material
  • Fill and finish (outsourced)
  • Freeze-drying (outsourced)
  • Release assays
  • Drug product completed pre-clinical toxicology

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