Kinetra Bio · Bioprocess Intelligence

See the excursion before it becomes the DEVIATION

Real-time deviation detection, intervention intelligence, and adaptive process qualification — for mammalian, microbial, and cell therapy manufacturing.

Request Validation Engagement See the platform

Runs locally on client hardware · No data transmitted · CSV-based · No installation required

The platform

The data is faster
than you are. Kinetra closes that gap.

Kinetra Engine reads your process data against your golden batch and fires — before thresholds breach, before cascades begin. Specific intervention recommendations. Organism-specific failure mode logic. Process Deviation Index updated in real time.

01 · DETECT
Three-layer detection
Divergence from golden batch fires first — before any threshold is breached. Warn and critical layers follow with specific targets and escalation paths.
02 · INTERPRET
Process Deviation Index
Evidence-weighted risk scoring by organism and run stage. Literature-calibrated baselines. Facility-calibrated during the validation engagement. Not a black box.
03 · ACT
Specific intervention recommendations
Not "increase aeration." Increase agitation by 100 RPM, airflow to 1.5 VVM, target DO above 40% within 30 minutes. Every recommendation includes a target and an escalation path.
Process modules

Seven organism modules.
One engine.

Each module carries organism-specific failure mode logic, threshold detection, and golden batch comparison. CHO Fed-Batch, E. Coli, and Pichia Pastoris modules carry independent FP/TP validation against published in vitro datasets.

CHO
CHO Fed-Batch
Mammalian · 240h
E.COLI
E. Coli
Microbial · 30h
BAC
Bacillus
Microbial · 36h
YEAST
Yeast
Microbial · 36h
ANA
Anaerobic
Microbial · 48h
PICH
Pichia Pastoris
Microbial · Mut+ · 144h
CAR-T
Allogeneic CAR-T
Cell Therapy · Research Module
v6.0
More modules in development
Process Deviation Index

Not a black box.
Every number has a source.

The PDI is an evidence-weighted risk score — not a probability claim. Literature-calibrated baselines. Facility-calibrated during the validation engagement. Transparent evidence list. Every item that drives the index is visible and auditable.

PROCESS DEVIATION INDEX
75/100
ELEVATED · Bacillus · Hour 28 of 36 · Late stage
Literature baseline: 20 Evidence-weighted: 75
EVIDENCE DRIVING INDEX
› Critical alert active (2)
› Warning alert active (2)
› Divergence >100% from golden batch — extreme
› Multiple parameters diverging (6)
› Sporulation index elevated
› Glucose approaching sporulation trigger
Evidence weight: 12x · Literature-calibrated
Facility-calibrated during validation engagement
Adaptive Process Qualification

The engine qualifies itself.
The log is your campaign record.

Kinetra generates contextually relevant qualification challenges throughout your production campaign based on real-time process state. Not a fixed test script — an adaptive qualification system that responds to where your process is right now.

At hour 12 of a Bacillus run with glucose diverging, the APQ agent generates a sporulation-focused challenge — because that is the most relevant failure mode at that stage. At hour 28 with protease rising, it generates a different challenge. Every challenge is logged with timestamp, organism, run hour, failure mode, and pass/fail verdict.
"The engine does not just qualify itself — it designs its own qualification tests based on what it has observed about your process."
APQ CAMPAIGN LOG — SAMPLE
Glucose Depletion Sporulation Trigger
Bacillus · Hour 12 · Mid stage · HIGH confidence
PASS
Irreversible Sporulation Cascade
Bacillus · Hour 24 · Late stage · HIGH confidence
PASS
Protease-Driven Product Degradation
Bacillus · Hour 28 · Late stage · HIGH confidence
PASS
Export CSV · Export Campaign Report
Security and data handling

Your data never
leaves your environment.

Kinetra Engine v5.9.8 runs on your hardware. No network connection. No cloud dependency. No data transmitted. The local deployment architecture makes this commitment technically enforceable — not just contractual.

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No data transmitted — batch CSV data never leaves your environment. Kinetra Bio has no mechanism to access your process data.
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No installation required — runs as a single HTML file in any modern browser. No server, no IT infrastructure, no administrator rights.
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No internet connection required — runs fully offline. Can be operated on an air-gapped machine with no degradation of functionality.
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Outside IQ/OQ/PV scope — decision support tool only. Every recommendation requires scientist confirmation. Does not control or write to any validated system.
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Mutual NDA — all engagements governed by mutual NDA with reference provision. Data handling terms cover retention, deletion, and permitted use.
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IT Security Assessment available — complete technical documentation provided prior to engagement commencement.
Deployment

The engine is ready.
The conversation starts here.

Kinetra Engine v5.9.8 is available now for facilities running mammalian, microbial, or cell therapy processes. Deployment is a single HTML file. No installation, no IT project, no data transmitted.