Lyophilization station

Lyovex

Freeze-dry cycles that protect every cake.

Lyovex models and controls the freeze-dry cycle so you can shorten it safely, without collapsing the cake or losing potency.

Lyovex logo

The problem

Why this station is so unforgiving.

Lyophilization is the slowest, costliest, riskiest step on the line. Cycles run for days, and one wrong shelf-temperature or pressure ramp collapses the cake, ruins potency, or adds hours across a million-dollar batch.

Cycle design stays craft-bound and conservative because the sublimation front is inferred, not seen. Meanwhile lyo capacity is a chronic bottleneck in the biologics and GLP-1 boom, and the experts who can safely shorten a cycle are scarce.

What Lyovex does

Freeze-dry cycles that protect every cake.

Lyovex uses physics-informed models and a Simura twin to optimize the ramps before the batch, then adapts in-run as it tracks shelf temperature, chamber pressure, and the sublimation front.

It compresses cycle time inside a validated design space, with change control and a Part 11 audit trail, so you protect cake structure and potency while getting hours back.

Capabilities

Built for the lyophilization station.

F01

Physics-informed cake and sublimation modeling with adaptive in-run control

F02

Pre-batch cycle optimization through the Simura twin, then safe cycle-time compression

F03

Design-space and validated-envelope enforcement with change control

F04

Prognostics for collapse risk, potency risk, and equipment drift

F05

Part 11 audit trail and connectors for lyophilizers and MES

At a glance

Where Lyovex runs, and for whom.

Recurring SaaS that lands on one station and expands across the suite and the fleet, on a paid pilot measured against a hard reject, deviation, or yield metric.

See pricing
CategoryLyophilization cycle control
Deploys onDGX/HGX for modeling; Jetson at the edge
FormatsVials for biologics, vaccines, parenterals
BuyersLyo and process engineers, VP Manufacturing, QA
Outcome27% shorter cycle time
PricingFrom $14k per line / month

One ecosystem

Lyovex is one station of the Sterira suite.

Lyovex optimizes each cycle in the Simura twin and passes container-closure signals to Vistra for inspection.