By modality
Autonomous operations for every biologics modality.
Bioseon helps CDMOs and biopharma manufacturers run mAbs, vaccines, GLP-1 and recombinant proteins, and cell and gene therapies with proof-driven control.
Every batch, perfectly cultured.
One operating layer, tuned by molecule and process.
Biologics pipelines need modality-specific control while preserving GMP discipline. Bioseon connects live process sensing, deterministic envelopes, and human oversight to the realities of each product class.
- Support QbD programs aligned with ICH Q8–Q11.
- Use PAT/Raman soft-sensing where inline quality signals matter.
- Connect upstream, downstream, and record evidence.
Culture state
CQA risk
Evidence
Keep monoclonal antibody batches inside the proven design space.
Bioseon supports fed-batch, intensified, and perfusion strategies with feed optimization, titer sensing, and CQA-aware control envelopes.
- Cell growth and productivity context in one timeline.
- Soft-sensing for titer and quality risk indicators.
- Batch records that connect control actions to release evidence.
Vaccine operations
Connect growth, harvest, purification, and release evidence while controlling variability that can slow campaign execution.
Vaccines require campaign discipline and rapid exception visibility.
Bioseon helps teams monitor critical process behavior, flag deviations earlier, and preserve traceability across time-sensitive manufacturing programs.
- Support GMP campaign readiness.
- Track exceptions across lots and equipment.
- Prepare records while manufacturing continues.
GLP-1 and recombinant proteins need scalable, repeatable control.
For recombinant proteins, process consistency is a capacity multiplier. Bioseon helps teams standardize control envelopes, spot drift, and link process context to yield and quality outcomes.
- Designed for high-demand production networks.
- Supports soft-sensor signals and recipe evidence.
- Reduces preventable investigation burden.
Scale
Transfer proven envelopes across lines.
Yield
Keep process levers visible.
Small batches, high consequence decisions.
Bioseon keeps provenance, interventions, and exception review close to the patient-critical process.
More context for complex, variable, patient-linked workflows.
Cell and gene therapy teams need careful control with human override. Bioseon captures action provenance, deviation context, and review evidence for advanced therapy manufacturing.
- Human oversight remains explicit.
- Records stay tied to process state.
- Exceptions are visible before review backlog builds.
Built for CDMOs and biopharma manufacturers.
Different operating models, the same need for controlled, traceable, high-throughput biologics production.
| Need | CDMOs | Biopharma manufacturers |
|---|---|---|
| Tech transfer | Rapid onboarding of client processes | Consistent site-to-site execution |
| Capacity | Maximize line utilization across programs | Reduce bottlenecks in strategic products |
| Quality | Client-ready evidence and deviations | Inspection-ready release confidence |
| Economics | Protect margin through less rework | Improve predictability across portfolios |
Outcomes across modalities.
Control, sensing, and records stay connected.
Exceptions replace exhaustive normal-event review.
Teams see risk signals before reprocessing expands.
What target customers are asking for.
“Bioseon is the kind of operations layer we want between advanced process control, quality review, and the realities of regulated biologics manufacturing.”
Aspirational customer voice, representative of target CDMO and biopharma needsSolutions FAQ.
Which modality should start first?
Start where process variability, review burden, or capacity pressure is highest.
Does Bioseon require fully autonomous release?
No. Humans retain approval and override authority. Bioseon provides control context and evidence.
Can one site run multiple modalities?
Yes. The platform is designed to support multiple lines, skids, and manufacturing strategies.
Choose the modality where autonomy changes the economics fastest.
Pricing starts at $13,000 per skid per month, with site and enterprise options for scaled programs.