Perceive
Collect DCS tags, PAT and Raman spectra, historian data, MES context, lab results, and environmental signals.
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Autonomous operations layer
Run biologics manufacturing as one controlled system.
Bioseon connects upstream culture, downstream purification, robotics, contamination intelligence, batch records, and a bioreactor-and-facility digital twin. Every batch, perfectly cultured.
7+1
Seven agents plus one digital twin.
A governed control mesh for CDMOs and biopharma manufacturers producing mAbs, vaccines, GLP-1 and recombinant proteins, and cell and gene therapies.
What the platform is.
Bioseon is the autonomous operations layer for biologics manufacturing. It perceives culture and skid state, predicts where the batch is heading, acts inside validated limits, and records every decision for GMP review.
- Built for upstream bioreactors and downstream purification skids
- Designed for GMP, 21 CFR Part 11, and ICH Q8–Q11 quality-by-design programs
- Deploys over existing DCS, MES, historians, PAT, and single-use infrastructure
BR-04 live state
- pH 7.02, DO 41 percent, temperature 36.9 C
- VCD 18.4e6 cells per mL, titer 6.41 g/L
- Actions held inside validated control envelopes
Seven agents close the loop from recipe to release.
Each agent owns a manufacturing domain. The twin coordinates them against the same live batch objective.
- MEDIA & SEED
Media-and-seed agent
Runs media and buffer prep, seed-train readiness, composition checks, and sterility status.
- CULTURE & FEED
Culture-and-feed agent
Controls pH, DO, temperature, agitation, CO₂, and fed-batch or perfusion feed.
- TITER & CQA
Titer-and-CQA agent
Uses PAT and Raman soft-sensing for titer, VCD, metabolites, and quality signals.
- HARVEST & PURIFY
Harvest-and-purify agent
Runs clarification, capture, polish, UF/DF, viral steps, pooling, and yield protection.
- ROBOT & HANDLING
Robot-and-handling agent
Coordinates robotic sampling, media prep, single-use assembly, and material handling.
- CONTAMINATION
Contamination-and-deviation agent
Fuses bioburden, environmental, and process signals into a live deviation picture.
- RECORD & REVIEW
Record-and-review agent
Builds the GMP batch record continuously with 21 CFR Part 11 auditability.
- DIGITAL TWIN
Bioreactor-and-facility twin
Coordinates the seven agents against target titer, CQA, yield, and release state. See the twin →
Architecture: perceive, predict, act, record.
Predict
Soft sensors and the twin forecast VCD, titer, CQAs, yield, risk, and release readiness.
Act
Agents adjust feed, gas, agitation, chromatography loads, pools, and UF/DF setpoints inside approved limits.
Record
Every observation, recommendation, action, exception, and approval lands in an auditable Part 11 record.
Connect the systems already running the suite.
DCS and PLCs
Read process variables and write approved setpoints through validated interfaces.
MES and eBR
Align actions to recipe phase, equipment state, materials, and batch-record context.
Historians
Train and validate models against prior batches, deviations, and process trajectories.
PAT and Raman
Turn spectra and online measurements into soft-sensed titer, VCD, metabolites, and CQAs.
Single-use skids
Coordinate bioreactor, feed, chromatography, filtration, and UF/DF equipment.
A digital twin for the bioreactor and facility.
The twin simulates cell growth, feed demand, titer formation, purification yield, and facility constraints. Agents use it to choose the next best action before drift becomes a deviation.
Twin vs live · BR-04
PredictedLiveTarget spec
Deployment path from connection to closed loop.
- 01
Connect
Map equipment, tags, recipes, materials, and historical batches.
- 02
Calibrate soft sensors
Validate PAT, Raman, lab, and historian models against known process runs.
- 03
Run shadow mode
Compare recommendations to operator decisions without changing the process.
- 04
Close the loop
Enable constrained setpoint control with human override and full audit trail.
- 05
Expand
Roll from one bioreactor or skid to more lines, modalities, and sites.
Measured on manufacturing value.
TITER AND YIELD
Up. Closed-loop upstream and downstream decisions improve productivity and consistency.
CONTAMINATION
Down. Live risk fusion catches weak signals across process and environment.
DEVIATIONS
Down. Deterministic envelopes and review-by-exception reduce rework.
CONSUMABLES
Optimized. Media, Protein A resin, and single-use inputs are controlled against real process state.
Built per modality.
The same operating layer is tuned to the molecule, cell line, process window, and CQA set.
mAbs
Fed-batch and perfusion CHO processes tuned for titer and glycan consistency.
View solutionsVaccines
Viral and recombinant platforms with contamination-first process monitoring.
View solutionsGLP-1 and proteins
Recombinant and microbial expression with fermentation and recovery control.
View solutionsCell and gene therapy
Traceable patient-linked workflows where every batch needs tight provenance.
View solutionsTrust, validation, and inspection readiness.
Bioseon supports GMP operations with role-based access, deterministic control limits, validation evidence, and 21 CFR Part 11 audit trails. It is designed to augment your quality system, not bypass it.
- GMP-aligned change control and release workflows
- ICH Q8–Q11 quality-by-design traceability
- Human override for closed-loop actions
- Action provenance from signal to record
Start with one line, expand to the site.
Line
$13,000 per bioreactor or skid per month, for one culture, fermentation, or purification train.
Site
$85,000 per month for whole-facility autonomy across agents and the twin.
Enterprise
Custom programs with land from $700k–$8M ACV for multi-site validation, edge fleet, and SLAs.
Platform questions.
Does Bioseon replace DCS or MES?
No. Bioseon connects to existing DCS, MES, historians, PAT, and skid systems, then acts through validated interfaces and control envelopes.
Which standards does it support?
Bioseon is built for GMP operations, 21 CFR Part 11 auditability, ICH Q8–Q11 quality-by-design, PAT and Raman soft-sensing, single-use, and perfusion environments.
Who uses the platform?
CDMOs and biopharma manufacturers use Bioseon to operate biologics lines across upstream, downstream, quality, and manufacturing science teams.
Can we start on one train?
Yes. The Line tier starts at $13,000 per bioreactor or skid per month, then expands to Site or Enterprise when the value is proven.
Put a governed autonomy layer around your next biologics line.
Request access and map Bioseon to one bioreactor, skid, or full site.