Industry: Biopharma & Biologics

Biologics & Cell Therapy Manufacturing ERP

Track upstream cell culture, downstream purification, aseptic fill-finish, and cold-chain custody with the batch integrity biologics demand.

Biologics & Cell Therapy Manufacturing ERP

Cold Chain & Sterility Assurance

Continuous temperature/humidity custody logs from cell bank to fill-finish, with excursion alerts and chain-of-custody sign-off.

Bioreactor & Upstream Tracking

Log seed train, bioreactor run parameters, feed schedules, and harvest yields against approved process ranges.

Potency & Bioassay Integration

Link CoA release to potency assays, bioburden, endotoxin, and mycoplasma results before batch disposition.

Real-TimeBioreactor parameter logging
UnbrokenCold-chain custody records
AsepticFill-finish batch execution
FullUpstream-to-release traceability

Built to handle the messy reality of pharma operations

Batch records, sensor telemetry, quality interlocks, and compliance infrastructure built for modern life science plants.

01

Upstream & Downstream Process Records

Guide operators through seed train expansion, bioreactor runs, and downstream chromatography/filtration steps with in-process control limits and deviation flags built in.

  • Bioreactor run parameter capture with in-process control alerts
  • Downstream purification step-by-step electronic records
  • Harvest and titer yield tracking across upstream stages
Upstream & Downstream Process Records
02

Aseptic Fill-Finish & Environmental Monitoring

Connect grade-A/B fill-finish batch records to environmental monitoring data, gowning qualification status, and media fill history for full aseptic assurance.

  • Environmental monitoring data linked to batch disposition
  • Operator gowning qualification & media fill interlocks
  • Cold-chain custody log from harvest to distribution
Aseptic Fill-Finish & Environmental Monitoring

Make every pharma operation more connected

One AI-native ERP for production, quality, inventory, finance, and compliance.