BioMedAna TWIN · BIOPROCESS PREDICTION AND SIMULATION

Predict yield, quality and deviations before the next run.

BioMedAna Twin combines complete, ontology-aligned data from Hub with physics, domain science and in-house, modality-trained AI/ML. Simulate process behavior, compare operating conditions and identify robust operating windows from bench to commercial scale — with evidence and uncertainty attached.

Predict and simulate — from bench to scale.

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.

BioMedAna 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.

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

Security, governance, auditability and model lifecycle throughout.

05 — MODALITY-SPECIFIC INTELLIGENCE

One platform.
Different science by modality.

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

01CHO · mAb

Monoclonal antibodies

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

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

02CHO · Microbial

Recombinant proteins

Understands: Expression kinetics · host response · purification behavior · batch variability

Predicts: Titer / yield · quality attributes · scale-up behavior · confidence

03CAR-T · TIL · NK

Cell therapies

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

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

04AAV · Lentiviral

Gene therapies and viral vectors

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

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

05Bacterial · Yeast

Microbial and precision fermentation

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

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

06ASO · siRNA

RNA and oligonucleotides

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

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

06 — PREDICTION WITH A REASON

Show the prediction.
Show what holds it up.

BioMedAna 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 — THE PIPELINE, RUNNING LIVE

Data in. Decision out.
Every step connected.

The same node-to-node execution shown in the real Twin canvas — data, engineering calculations, simulation, scoring and optimization feeding forward continuously into a single reviewable decision.

Workflow Studio — Live Pipeline

Connected data, engineering, simulation and decision nodes — run continuously in a loop, one node at a time, exactly as the real canvas executes.

CYCLE1 / ∞
SOURCERun DataCHO fed-batch · 2,000 LCOMPUTEEngineering CalckLa · OTR · P/V · tip speedCOMPUTEProcess SimulationTiter / viability trajectoryANALYZEQuality ScoreComposite CQA scoreANALYZETrade-off OptimizerPareto search, 3 objectivesANALYZEOperating WindowRecommended range + riskDECIDEDecisionReviewable recommendation
Live execution: each node's status reflects the real dependency order — data feeds both engineering calc and simulation in parallel, both feed the quality score, which fans out to the optimizer and operating-window nodes, converging on a single reviewable decision.

09 — 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.BioMedAna.ai/twinBioMedAna 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

10 — TRY IT YOURSELF

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

This sandbox mirrors how BioMedAna 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

11 — HUMAN-GOVERNED

Intelligence proposes.
Science decides.

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

Explore governance

12 — ONE PLATFORM, MANY DECISIONS

The same intelligence foundation.
Development through manufacturing.

BioMedAna 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

13 — 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.

14 — BUILT FOR PROCESS DECISION-MAKERS

Every role.
A decision Twin supports.

01Process Development

Design fewer, higher-value experiments

02MSAT

De-risk scale-up, transfer and comparability

03Manufacturing Sciences

Anticipate batch behavior and investigate deviations

04R&D Digital & Data

Govern data, models and integration with the existing stack

05Quality & CMC

Review predicted quality outcomes with traceable evidence

06Leadership

Understand development risk, process maturity and capacity implications

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