Case study: Recombinant first in class antimicrobial for pre-clinical toxicology

Customer problem

  • Need for efficient and scalable recombinant production of novel bacteriocin to support pre-clinical Toxicology and aggressive cost-of-goods target
  • Means to overcome toxicity of bacteriocin to production host

Ingenza solution

  • Biomanufacturing titre increase from µg’s to multi-gram/L enabling highly competitive COGS
  • Scarless-removable fluorescent fusion to mask toxicity and optimise upstream/downstream
  • Management of formulation and successful pre-clinical Toxicology
Host
  • P. Pastoris HCD fermentation
  • Tolerance to target via removable fluorescent tag
Build & Screen
  • Design and integration of constructs
  • FACS supported visABLE® screen for jackpot clones with optimal productivity/stability
Manufacture
  • Manufacturing process developed - 20 L fermentation and scalable DSP
  • Multi-gram >95% pure, fully active target per run
Pre-clinical testing
  • Drug substance formulated at 3rd party
  • Successful pre-clinical toxicology

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