BioAna Twin

Predict & simulate. From bench to scale.

Modality-native predictive and simulation intelligence for biologics, cell therapy, gene therapy, fermentation and RNA/oligo processes — connecting physics, process data and AI/ML so teams can understand, predict, simulate and decide with confidence.

01 — THE OPPORTUNITY

“Bioprocess development is still constrained by physical experimentation. Complex biology makes every run valuable, but much of what is learned remains difficult to reuse.”

Today, teams rely on run → analyze → learn → adjust — another physical run to validate the next change. That means more experiments, slower learning and knowledge fragmented across data, models and SME memory. The opportunity: learn more from every run, and predict before the next one.

02 — SCALE CHANGES MORE THAN THE REACTOR

The engineering changes.
Biology responds.
Quality follows.

From bench and development scale, through pilot, to commercial scale — the scale-up challenge is finding the operating conditions that preserve biology and product quality as the engineering environment changes.

01Engineering

Mixing & hydrodynamics, mass transfer / kLa / OTR, shear & gradients, geometry and operating conditions change.

02Biology

Growth & viability, metabolism, lactate & ammonia and cellular stress respond.

03Quality

Titer & yield, CQAs, batch consistency and process robustness emerge.

03 — SCIENTIFICALLY CONSTRAINED

Physics constrains. Data grounds.
AI learns. Science guides.

BioAna combines physics, process history, AI/ML and domain knowledge to predict what is likely to happen before the next run.

01

Physics

Mixing · mass transfer · shear · scale effects

02

Data

Historical runs · process conditions · biology · quality

03

AI / ML

Learn relationships · predict outcomes · explore scenarios

04

Domain knowledge

Biology · constraints · SME expertise

Performance titer / yieldQuality CQAsOperating window recommended conditionsConfidence uncertainty / risk

04 — HUB + TWIN, THE CLOSED LOOP

A digital twin is only as good
as the context behind it.

BioAna Hub continuously connects, contextualizes and aligns process data so BioAna Twin can predict, simulate and improve with every run — governed end to end by BioAna OS.

01
Connect

Bioreactors, historians, PAT, ELN/LIMS, MES and lab data.

02
Hub: contextualize

Run alignment, equipment context, process + quality data.

03
Twin: predict & simulate

Scale-up, what-if scenarios, operating windows.

04
Decide

Scientist/engineer compares scenarios and selects conditions.

05
Learn

New run, new evidence feeds back into the loop.

06
BioAna OS

Security, governance, auditability and model lifecycle throughout.

05 — MODALITY-SPECIFIC INTELLIGENCE

One platform.
Different science by modality.

BioAna Twin keeps the platform core consistent while adapting scientific context, models and decision logic to each modality it predicts for.

01CHO · mAbs

Biologics

Understands: Growth & viability · kLa/OTR/mass transfer · mixing & scale effects · CPP → CQA relationships

Predicts: Titer / yield · CQAs · scale-up behavior · operating window · confidence

02CAR-T · TIL · NK

Cell therapy

Understands: Growth & viability · phenotype evolution · transduction/editing efficiency · donor variability

Predicts: Expansion yield · phenotype/composition shifts · potency indicators · confidence

03AAV · Lentiviral

Gene therapy

Understands: Vector production kinetics · transfection efficiency · multiplicity/dose effects · batch variability

Predicts: Vector yield · quality attributes · potency indicators · scale-up behavior

04Bacterial · Yeast

Fermentation

Understands: Growth kinetics · substrate uptake · oxygen demand · overflow metabolism · scale effects

Predicts: Biomass / yield · product titer · OUR/OTR limits · feed trajectory · productivity

05ASO · siRNA

RNA & Oligo

Understands: Reaction efficiency · impurity formation · purification performance · batch variability

Predicts: Yield · purity · impurity profile · product quality attributes · confidence

06CDMO · Enterprise

Multi-program

Understands: Client, program and modality context preserved across a shared platform core

Predicts: Program-specific models and predictions within governed tenant boundaries

06 — PREDICTION WITH A REASON

Show the prediction.
Show what holds it up.

BioAna Twin keeps predictions connected to experimental evidence, process constraints, model version and uncertainty—so teams can challenge the answer before acting on it.

Evidence selected historical runsConstraints engineering + biologyReview required before action
Predicted outcomeObserved evidenceConfidence region
Normalized process responseCulture duration
Day 0Day 3Day 6Day 9Day 12Harvest
MODELED OPERATING REGIONConstrained by oxygen-transfer and shear limits

07 — SEE THE WHOLE SPACE

The answer isn't a number.
It's a region.

Single-point predictions hide the trade-offs. Twin maps predicted performance across the full operating space — showing where the process is robust, where it is fragile, and where the next experiment would teach the most.

  • Predicted response surface across CPP combinations
  • Historical runs overlaid on the same coordinates
  • Recommended exploration region with uncertainty attached

08 — REAL PRODUCT

A decision workflow.
Not a model gallery.

What changes when process assumptions move?

Day-by-day prediction of titer, viability and glycoforms with a disclosed uncertainty band — before any material is committed.

app.bioana.ai/twinBIOANA TWIN
PROGRAMmAb IgG1 · CHO fed-batchDECISION2,000 L → 10,000 L transferOBJECTIVEQuality Objective BSCREEN01 · Process Simulation

Process Simulation

Day-by-day trajectory prediction with disclosed uncertainty

Scenario InputsCOMMERCIAL-LIKE
Scale10,000 L
Agitation57 RPM
Aeration0.206 vvm
DO setpoint45 %
Temperature37.0 → 34.5 °C
pH7.00 constant
Glucose strategyStandard fed-batch
Harvest dayDay 14
GUIDED SCENARIOSBaseline 2K transferCooler production phaseAggressive feedpH shift day 6
Predicted Trajectory±8.1% uncertainty · model v2.1
Titer (normalized)ViabilityConfidence band
Day 0Day 3Day 6Day 9Day 12Harvest
Titer2.451 g/L±0.19
Viability91.9 %
G0 / G1 / G239 / 34 / 21 %
Lactate1.8 g/L
Ammonia3.1 mM
Quality score87 / 100vs. Objective B

09 — TRY IT YOURSELF

Move the levers.
Watch the trade-offs move too.

This sandbox mirrors how BioAna Twin frames a scenario — inputs on the left, predicted response on the right, and a confidence signal attached to every result. No data leaves this page and nothing writes back to a control system.

SCENARIO 04 · SCIENTIST SANDBOXSimulation only

Explore the operating space. No control-system writeback occurs from this demo.

Bench
2,000 L
Predicted titer4.95 g/L
End viability91.1%
Model confidence90%
Operating-window signalPromising · review
SCIENTIST REVIEWCandidate operating region

Feed +4% · DO ≥ 32% · agitation constrained

Evidence attachedModel v2.1Review required

10 — HUMAN-GOVERNED

Intelligence proposes.
Science decides.

BioAna produces evidence-linked recommendations with uncertainty, review context and approval gates—not invisible automation.

Explore governance

11 — ONE PLATFORM, MANY DECISIONS

The same intelligence foundation.
Development through manufacturing.

BioAna applies the same connected data, modality context and predictive intelligence across the full process lifecycle — and into manufacturing support for deviations, root-cause analysis and continuous improvement.

01Process development

Design better experiments

02Scale-up optimization

Predict larger-scale behavior

03Feed / process optimization

Tune operating conditions

04Product quality prediction

Anticipate CQAs and performance

05Tech transfer

Carry process knowledge forward

12 — THE EXPERIMENTAL DIVIDEND

Run the sweep virtually.
Spend the reactor time where it counts.

A physical DoE across feed, DO and agitation can consume a quarter of experiments. Twin sweeps that space in silico against models, physics constraints and prior evidence — so the committed runs are chosen, not guessed.

Start with one decision

Make process uncertainty visible.

Define the evidence, physics, model and validation path needed to support your next scale-up, transfer or PPQ decision.

Design a Twin pilot