mAbs
Monoclonal antibodies in fed-batch and perfusion CHO, tuned for titer and glycan control.
Physical AI · Biologics upstream & downstream bioprocessing
Every batch,
perfectly cultured.
Biologics aren't synthesized; they're grown. Bioseon is the autonomous operations layer for the bioreactor and the purification skid: it perceives culture health and controls the process, batch after batch, so titer lands high, CQAs land on-spec, and deviations don't.
- Live-sensed
- titer & CQA
- Closed-loop
- feed & perfusion
- Part 11
- audit trail
BR-04 · PRODUCTION BIOREACTOR
CULTURING
TITER g/L · day 0 → 14
6.41
Upstream bioprocessing runs at the edge of biology, chemistry, and fluid dynamics. By hand.
Living CHO or microbial cells must be held in a narrow viability window for days to weeks. A small drift in feed or gas can crash viable cell density, starve the culture, or subtly shift the glycosylation and charge variants that decide whether the drug is safe and efficacious.
- CONTAMINATION
One bioreactor contamination or viral event destroys a batch worth millions and idles a suite for weeks.
- VARIABILITY
Titer and CQA drift force reprocessing, deviations, and regulatory scrutiny under GMP and Part 11.
- BLIND OPS
Plant managers run blind on real-time culture health, purification yield, and batch-release readiness.
- SCARCE CRAFT
The MSAT and process scientists who nurse the culture are a scarce, aging craft, and capacity is chronically short.
Seven agents close the loop from perception to bioreactor-and-skid control.
Each agent owns a stage of the process. Together they run the facility, encoding the process scientist's craft and acting, not just advising.
- MEDIA & SEED
Media-and-seed agent
Runs media/buffer prep and the seed train, controlling composition, sterility, and inoculum readiness.
- CULTURE & FEED
Culture-and-feed agent
Holds pH, DO, temperature, agitation, CO₂ and fed-batch/perfusion feed at peak viable cell density.
- TITER & CQA
Titer-and-CQA agent
Senses and predicts titer, VCD, metabolites, glycosylation, and charge variants via PAT/Raman soft sensors.
- HARVEST & PURIFY
Harvest-and-purify agent
Runs clarification, chromatography, UF/DF and viral steps, controlling load, gradients, pooling, and yield.
- ROBOT & HANDLING
Robot-and-handling agent
Drives robotic sampling, media prep, and single-use assembly and handling on the floor.
- CONTAMINATION & DEVIATION
Contamination-and-deviation agent
Fuses bioburden, environmental, and process signals into a live contamination and deviation picture.
- RECORD & REVIEW
Record-and-review agent
Runs batch-record review by exception with a full 21 CFR Part 11 audit trail.
- DIGITAL TWIN
One model over all seven
A bioreactor-and-facility twin coordinates every agent against the target spec. See the twin →
The product line
Five modules you can buy one at a time.
Each product owns a stage of the batch and lands on a single train. Together they run the facility. See all products →
-
CulteonUPSTREAM CONTROLAutonomous cell culture that holds the bioreactor in its productive window, moving feed and gas ahead of the drift.
Explore Culteon → -
TiteonTITER & CQA SENSINGReal-time titer and quality-attribute readings before the offline assay lands, each with a confidence and a source.
Explore Titeon → -
PurionDOWNSTREAM PURIFICATIONAutonomous downstream purification that recovers more drug per column and predicts breakthrough before it happens.
Explore Purion → -
SentiraCONTAMINATION & REVIEWEarly warning on contamination and deviations, plus batch-record review by exception with a Part 11 trail.
Explore Sentira → -
TwineonDIGITAL TWINSimulate the batch to spec, then run it for real, and generate the rare failures every other module learns from.
Explore Twineon →
A closed control loop around every vessel.
- 01
Perceive
Soft sensors and PAT streams estimate titer, VCD, metabolites, and CQAs in real time; environmental and bioburden signals fuse into a live risk picture.
- 02
Predict
The digital twin projects the batch forward against your cell line and process, flagging where titer or a critical quality attribute would drift off-spec.
- 03
Act
Agents adjust feed, gas, agitation, and gradient schedules on the bioreactor and skids, then log every action to a Part-11 audit trail.
- 04
Release by exception
Batch records assemble continuously; reviewers see only the deviations that matter, cutting review time and reprocessing.
Hit the target titer and CQA spec before the batch runs.
The digital twin simulates culture, feed, and purification across the seed train, production bioreactor, and skids. Bioseon searches feed profiles, gas strategies, and gradient schedules against your process, then commits the plan the live agents execute and adapt in real time.
- Adaptive feed & perfusion control tuned to the live culture
- Grounded, auditable outputs; every action traceable
- Faster tech transfer and scale-up from lab to manufacturing
TWIN vs LIVE · BR-04Δ 0.3 g/L
Predicted
Live
Target spec
Priced and measured on value, not seats.
TITER & YIELD
Up. Closed-loop feed and purification control lift productivity and consistency, batch over batch.
CONTAMINATION
Down. Live fusion of bioburden and process signals catches events before they take the suite offline.
DEVIATIONS & REVIEW
Down. Review-by-exception and a Part-11 audit trail cut reprocessing and reviewer load.
CONSUMABLES
Optimized. Media, Protein A resin, and single-use spend controlled against real culture state.
One platform, tuned per modality.
Vaccines
Viral and subunit platforms with contamination-first control and tight process windows.
GLP-1 & proteins
Recombinant and microbial expression at capacity, controlling fermentation and recovery.
Cell & gene
Autologous and allogeneic workflows where every batch is a patient and traceability is law.
Grounded, auditable, and validated for GMP.
Bioseon is built for regulated manufacturing from the first line of code: deterministic control envelopes, a complete 21 CFR Part 11 audit trail, and validation support that stands up to inspection.
- 21 CFR Part 11 data integrity and e-signatures
- ICH Q8–Q11 quality-by-design alignment
- Role-based access, SSO, and full action provenance
- Deterministic control limits with human override
Trusted by the teams who run the suites.
"Bioseon reads the culture the way our best process scientist does, then holds the feed steady through the night. Our titer variance dropped and our reviewers stopped chasing paper."
Start on one train. Run the whole facility.
Line
$13,000/ bioreactor or skid / mo
Cell-culture, fermentation, or purification-control AI for a single train.
DetailsSite
$85,000/ mo
Whole-facility autonomy across every agent and the twin.
DetailsEnterprise
Customland $700k–$8M ACV
Multi-site, custom models, edge fleet, validation, and SLAs.
Talk to usBefore you request access.
Does Bioseon replace my DCS or MES?
No. Bioseon sits on top of your existing control and manufacturing systems, reading their signals and issuing setpoints within validated envelopes. It complements the DCS and MES rather than replacing them.
How does it stay compliant under GMP?
Every perception, decision, and action is logged to a 21 CFR Part 11 audit trail with e-signatures and immutable provenance. Control envelopes are deterministic and reviewable, with human override at all times.
What does deployment on one train involve?
We connect to a single bioreactor or purification skid, calibrate soft sensors against your historical batches, and run in shadow mode before closing the loop. Most lines reach closed-loop control within a validation cycle.
Which modalities are supported?
mAbs, vaccines, GLP-1 and recombinant proteins, and cell & gene therapy. Models are tuned per cell line, process, and CQA set. See Solutions.
Become the facility where every batch is cultured, purified, and released on Bioseon.
Request access and we'll scope a bioreactor or purification train against your cell line and process.