Titer
Live product concentration estimates track harvest readiness and productivity against target.
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PAT, Raman, spectroscopy soft sensorsTiter and CQA sensing for live biologics control.
Bioseon estimates titer, viable cell density, metabolites, glycosylation, charge variants, and contamination in real time, grounded against offline assays and historical batches.
BR-04 production bioreactorculturing
Offline analytics are too slow for living cultures.
Biologics manufacturing still waits hours or days for at-line and lab results. By the time titer, metabolite, or CQA data returns, the culture may already have drifted. Bioseon brings the signal into the control room while the batch is still recoverable.
- Shorten the delay between sample, assay, and action.
- Expose viability, nutrient, and quality drift before excursion.
- Give process scientists a live view without replacing validated assays.
01
Soft-sensing layer
PAT, Raman, spectroscopy, historian signals, and batch context become continuous estimates for operators and agents.
What Bioseon senses.
The titer-and-CQA agent converts noisy process signals into real-time manufacturing intelligence.
Viable cell density
VCD and viability estimates show when the culture can sustain feed, oxygen transfer, and scale.
Metabolites
Glucose, lactate, glutamine, and ammonia trends expose nutrient stress and toxic accumulation.
Glycosylation
CQA models flag glycan risk before late assay confirmation.
Charge variants
Predicted variant movement helps hold the product inside the release specification.
Contamination
Process and spectroscopy anomalies feed a live contamination picture.
PAT and Raman pipeline
Signals are cleaned, aligned, and contextualized by phase, cell line, vessel, media lot, and recipe step before prediction.
A production pipeline for soft sensors, not a lab demo.
Bioseon ingests Raman and spectroscopy streams next to pH, DO, gas, feed, agitation, osmolality, and temperature. Models run continuously, respect validated ranges, and surface confidence so control actions stay reviewable.
Grounded and calibrated to your process.
- 01
Collect historical batches
Batch context, PAT signals, recipes, deviations, and assay data are assembled by process stage.
- 02
Align to offline assays
Lab results and timestamps are harmonized with online signals and sampling delay.
- 03
Calibrate soft sensors
Models learn the cell line, media, process window, and site-specific instrument behavior.
- 04
Validate
Performance is reviewed against held-out batches, error bands, and GMP validation expectations.
- 05
Deploy
Soft sensors run in shadow, then inform recommendations and closed-loop actions inside approved envelopes.
Prediction and offline assays work together.
Bioseon does not discard validated analytics. It adds a continuous estimate so the team can act between samples.
| Signal | Offline assay | Bioseon soft sensor | Operational use |
|---|---|---|---|
| Titer | High-confidence lab result | Continuous estimate with confidence | Feed and harvest timing |
| VCD | Sample-based count | Live viability trend | Culture stress detection |
| Metabolites | Periodic analyzer result | Between-sample forecast | Nutrient and lactate control |
| CQAs | Release and characterization assays | Early risk signal | Deviation prevention |
The CQA control loop starts with perception.
When a quality attribute begins to move, Bioseon connects the signal to the culture-and-feed, harvest-and-purify, and record-and-review agents. Actions stay inside deterministic control envelopes and are logged for 21 CFR Part 11 review.
- Estimate the current state.
- Project the batch forward.
- Recommend or execute the next validated move.
Seven-agent context
Media-and-seed, culture-and-feed, titer-and-CQA, harvest-and-purify, robot-and-handling, contamination-and-deviation, and record-and-review agents all share the same batch state.
Outcomes teams can measure.
FASTER VISIBILITYlive
See culture and quality movement between samples.
BETTER CONTROLon-spec
Guide feed, gas, and harvest decisions earlier.
LESS REWORKfewer
Reduce avoidable deviations and late surprises.
AUDITABLEPart 11
Keep every prediction, action, and review traceable.
Signal into simulation
The twin compares live sensed state with predicted state so agents can adapt the plan before titer or CQA risk compounds.
Real-time sensing keeps the digital twin honest.
The Bioseon digital twin simulates culture, feed, and purification across the seed train, production bioreactor, and skids. Soft sensors update that model continuously.
Start with one skid or scale across the site.
Pricing begins with Line at $13,000/skid/mo, Site at $85,000/mo, and Enterprise custom deployments.
Sensing FAQ.
Does Bioseon replace offline assays?
No. Offline assays remain the source of record. Bioseon provides real-time estimates that are grounded against those assays and used for earlier operational decisions.
Which standards does it support?
Deployments align to GMP, 21 CFR Part 11, ICH Q8-Q11 quality-by-design, PAT, Raman soft-sensing, single-use, and perfusion operations.
Can models be specific to my cell line?
Yes. Calibration uses your historical batches, process context, instruments, and assay data.
Turn every batch into a live, sensed process.
Request access and scope Bioseon soft sensors against your cell line, assays, and control strategy.