Applications

Soft sensors for predictive quality control

Predict CQAs in real time with hybrid physics-AI models. Built on your existing process data, they flag a batch heading out of spec and provide recommendations on how to correct it.

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Predict quality in real time. Correct the batch before it goes out of spec.

Soft sensors predict critical quality attributes between lab results, correct themselves as each result comes in, and recommend the adjustment that keeps the batch in spec.

See a Live Soft Sensor

How it works: soft sensors turn the data you already have into quality predictions.

01Inputs

Process tags, off-gas and any installed PAT probes stream in from the historian. Lab results calibrate the model.

Inputs
Process tags
temperature · pressure · flow
Off-gas
O₂ · CO₂
PAT probes, if installed
NIR · Raman · FBRM
Lab results
LIMS · for calibration
02Physics-AI modeling

Mass and energy balances form the backbone. AI fits what the physics doesn’t capture, so each prediction comes with a confidence interval.

Hybrid model
Physics
mass & energy balances
+
AI
learns what physics misses
Predicted CQA5.6 ±0.14
03Apps

Predictions feed monitoring, forecasts, alerts and control, and are written back to the historian.

Apps
Real-time quality monitoring
CQA between lab results
Endpoint and trend forecasts
with confidence
Early alerts
before a limit is crossed
Advanced process control
MPC within approved bounds

Predictive quality control with real-time visibility into every CQA.

Understand how your CQAs are trending, identify deviations, and receive recommended corrections to maintain on-spec production.

Traditional PAT vs. Basetwo.

Traditional process analytical technology (PAT) needs a dedicated sensor for every quality attribute you want to measure. With Basetwo, one model predicts them all from the process data you already collect.

Traditional PAT
One sensor for every measurement.
A dedicated probe or analyzer for each quality attribute, scale and vessel
Each one bought, installed, calibrated and maintained
To measureYou needCost
VCDCapacitance probe$
GlucoseRaman probe$$
TiterAt-line HPLC$$
Plus the software to run them
Orchestration platformConnects and schedules the PAT instruments$
PLS modelBuilt and maintained on the PAT data$
× 3repeated at Lab, Pilot and Plant9 sensors to calibrate
Basetwo
One model for every measurement.
Every attribute predicted from the process data you already collect
No new sensors to buy, install or calibrate
Data you have
TemperaturepHDOAgitationFeedOff-gas
Hybrid
soft sensor
Predicted live
VCD5.6 ×10⁶/mL
Glucose3.2 g/L
Titer2.4 g/L
Same model at Lab, Pilot and Plant0 new sensors
Continued process verification

Continued process verification (CPV) reports, generated automatically.

Stop assembling CPV reports by hand. Basetwo pulls batch data from historian, MES and LIMS, trends every CPP and CQA against its limits, flags signals for review and generates the report as a PDF, every month, quarter or N batches.

Basetwo›CPV Report · Quarterly
Export PDF
Summary
Batches reviewed24
CPP signals1 alert
OOS / OOT0
Process stateIn control
Scope
ProductBiologic A
ProcessFed-batch cell culture
SiteSite 1
PeriodQuarter 1
End-of-batch trendingbatchmeancontrol limits
Inoculation VCD (10⁶/mL)
UCL 1.20x̄ 1.02LCL 0.84
Culture duration (h)
UCL 319x̄ 308LCL 298
Harvest viability (%)
UCL 80x̄ 76LCL 71
Harvest pH
UCL 7.12x̄ 7.10LCL 7.08
Harvest titer (g/L)
UCL 5.7x̄ 5.4LCL 5.1
Max lactate (g/L)
UCL 2.66x̄ 2.42LCL 2.18
Max lactate in batch F08 is trending toward its limit. Flagged as a CPP signal for review; no OOS results this period.
With Basetwo
CPV reports generated from disparate systems
Basetwo pulls and aligns data across your historian, MES and LIMS, then generates control charts, capability and the annual review as ready-to-review PDF reports.
Control chartsI-MR · Nelson rules
CapabilityCpk · Ppk by quarter
ReportsPDF · APR / PQR drafted
Pulls from
HistorianMESLIMSERPSpreadsheets

Proven in production at leading manufacturers. Explore the case studies.

Questions PAT and quality teams ask

Usually not. Most soft sensors start from tags you already log, such as temperatures, flows and off-gas. Where an NIR, Raman or FBRM probe is installed, its signal is used as an input and the hybrid model makes it less sensitive to recalibration.

Fewer than a purely data-driven model, because the mass and energy balance carries most of the structure. A few dozen paired samples across normal operating variation is a typical starting point, and the model reports where it is under-calibrated.

It can produce the evidence, but RTRT is an agreement with your regulator, not a software setting. Most teams start with the soft sensor as in-process monitoring and decision support, and build the validation record toward RTRT from there.

The confidence interval widens and the sensor flags the inputs that are out of range. It never reports a confident number it can’t back up, and those periods are the samples the next retrain asks for.

Send us a month of process data and lab results. We'll build your first soft sensor on it.

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