Drug Complexing Platform for High Throughput Polyplex Manufacture

Drug Complexing Platform for High Throughput Polyplex Manufacture. allowing mixing of multiple reactants in serial micro-volume reactions and pooling of these to a larger output vessel in a closed system maintaining sterility from start to end.

Drug Complexing Platform

Manufacturing unit for rapid throughput mixing of multiple reactants in serial micro-volume reactions producing a pooled output in a large output vessel. Incorporated closed, sterile consumable to ensure sterility is maintained throughout the process.

The Instrument

Sterile Consumable

Project Structure

  • Initial meeting with client, MNDA complete and client requirements discussed (instrument and cartridge for rapid throughput mixing in a sterile system resulting in a large pooled output)

  • Initial project proposal delivered to client detailing initial phases and deliverables at each phase

  • Rapid prototyping to allow for POC (Proof of Concept)
  • Risks and boundaries established
  • Reviews at each phase

  • Prototype instruments (CE, ISO GMP Compliant) and consumables built (in house in cleanroom), and stress tested

  • FAT and SAT

Delivered Solution to Client

Adapted biochemical synthesis to invent a high-throughput manufacturing unit to produce the active pharmaceutical reagent.

Incorporated a closed, sterile consumable cartridge and instrument for “polyplex” generation.

  • In-house cartridge assembly in cleanroom
  • Instrument installed at partner CRO/CDMO
  • CE, ISO, GMP Compliant