BioMedAna TWIN · BIOPROCESS PREDICTION AND SIMULATION

Predict yield, quality and deviations before the next run.

BioMedAna Twin combines Hub data with physics, domain science and modality-trained AI/ML. Explore process behavior and operating windows from bench to commercial scale, with evidence and uncertainty attached.

Predict and simulate — from bench to scale.

BioMedAna TWINLIVE · BATCH BA-2471
Day14.0
Predicted titer5.25 g/L
Actual titer2.93 g/L
Day-14 forecast4.3 g/L
0246DAY 0DAY 7DAY 14
Deviation confirmed on day 9Twin flagged it 3 days earlier. Corrective feed window was available.

MSAT WORKFLOW

Investigate batch variability. Evaluate the next decision.

Follow a batch-performance signal through evidence comparison, competing hypotheses and a governed scenario review.

Explore the interactive MSAT use case ↗

TWIN USE CASES / THE DECISION COMES FIRST

From scale-up uncertainty
to an owned operating decision.

Explore scale-up, transfer and process recovery workflows, alongside scoped facility ramp-up and line-modeling engagements.

Explore all Twin use cases ↗

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.

  1. High mixing homogeneity, short gradients and kLa headroom. The process behaves as one well-mixed volume.

  2. Mixing takes longer and pCO₂ and DO gradients start to form. The same feed strategy sees a slightly different cell environment.

  3. Oxygen transfer and CO₂ stripping become scale-limited; shear and gradient trade-offs dominate the operating window.

SAME MODEL · SAME CONSTRAINTS · CARRIED EVIDENCE200 L
Pilot · 1.02 m tall
2 L50 cm1 m1.02 mGRID 25 cm
Impeller108 rpm
Mixing time17 s
Tip speed1.7 m/s
kLa9.9 h⁻¹
pCO₂79 mmHg
TWIN

Same model, carried evidence. Predicted titer 5.11 g/L, inside the validated operating window.

03 — SCIENTIFICALLY CONSTRAINED

Physics constrains. Data grounds.
AI learns. Agents coordinate.

BioMedAna brings together physics, chemistry and biology data, AI/ML, agentic workflows and domain knowledge to explore the next process decision.

1 of 5 contributorsTiter prediction vs. held-out runs · illustrative
0246NEW SCALE · HELD OUTDAY 0DAY 14
Agentic workflow · ManualConnect the evidence, select model tools and prepare the review.Expert approval stays with your team. Illustrative prediction metrics depend on the scientific model and data.
Fit error0.42 g/L
Error at new scale0.95 g/L
Physically plausibleNo

Bio Twin brings together mechanistic models, chemistry and biology data, AI/ML, agentic coordination and domain expertise to support higher-value experiments, operating-window exploration, scale-up assessment and earlier risk review.

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.

STEP 01 / 06Connect

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

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.

SCIENTIFIC CONTEXTILLUSTRATIVE / NOT TO SCALE08 / 08
VAX · Cell culture

Viral vaccines

Connect infection conditions to harvest and quality evidence. Data-driven predictions require held-out validation; mechanistic infection scenarios are not project-calibrated.

UNDERSTANDS
  • Cell-bank and seed-virus lineage
  • MOI and infection timing
  • infectious titre trajectories
  • viability
  • recovery and inactivation evidence
PREDICTS
  • Infectious titre at harvest
  • peak titre
  • cell-specific yield
  • harvest-window scenarios
  • model uncertainty

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
TWIN · SPATIAL EXPLORERINTERACTIVE CONCEPT

3D view · use the controls to explore the concept.

↔ DRAG TO EXPLORE
Synthetic geometry and dimensionless inputs. Explore the interaction; these visuals do not predict process performance.

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 L12 runs · 48 relationshipsCOMPUTEEngineering CalckLa · OTR · P/V · tip speedkLa 8.8 h⁻¹ · OTR okCOMPUTEProcess SimulationTiter / viability trajectoryTiter 4.9 g/L · VCD peak d9ANALYZEQuality ScoreComposite CQA scoreCQA score 0.86ANALYZETrade-off OptimizerPareto search, 3 objectives3 Pareto candidatesANALYZEOperating WindowRecommended range + riskDO 30–45 % · feed 3–4 g/L/dDECIDEDecisionReviewable recommendationFeed 3.5 g/L/d → review
RUN LOG

    Starting a new run…

    09 — REAL PRODUCT

    A decision workflow.
    Not a model gallery.

    Skip product journey ↓
    THE INTELLIGENCE JOURNEY01 / 03 ↓ SCROLL TO EXPLORE
    02 / INVESTIGATE · BIOMEDANA HUB

    Follow the signal. Find the context.

    Align batch trajectories, feed events and assay results before drawing a conclusion.

    ↗
    BioMedAna HUB● LIVE · ILLUSTRATIVE WORKSPACE
    HUB / INVESTIGATEEXAMPLE DATA
    Example runs0
    Feed conditions0
    Delayed-feed difference−0.0%vs control
    TITER TRAJECTORIES Hover to inspect · click a condition to toggle
    0246DAY 0DAY 7DAY 14
    │ feed start
    FINAL TITER g/L
    Control5.2
    High feed4.9
    Delayed feed3.8
    KEY OBSERVATIONTrajectories diverge after the delayed feed start (day 6).Next: check glucose and lactate profiles for R009.

    Association in illustrative data; not a root-cause conclusion.

    Illustrative data · expert review requiredHUB / 01
    03 / SIMULATE · BIOMEDANA TWIN

    Explore the process before the next run.

    Compare model scenarios, assumptions and uncertainty before committing material.

    ↗
    BioMedAna TWIN● LIVE · ILLUSTRATIVE WORKSPACE
    TWIN / SIMULATEEXAMPLE DATA
    Predicted final titer5.59 g/L
    Uncertainty± 0.22
    Evidence rangeWithinsupported by prior runs
    PROCESS RESPONSE Live scenario vs saved scenarios A–C
    0246DAY 0DAY 7DAY 14
    SCENARIO INPUTS auto-exploring · drag to take over
    ● Inside the evidence range
    • Growth: logistic kinetics fitted to 12 runs
    • Feed: daily bolus, constant composition
    • Scale: 2 L fed-batch, no scale correction
    Assumptions visible. Scientist review required.
    Illustrative data · expert review requiredTWIN / 02
    05 / DECIDE · BIOMEDANA ASSIST & AGENTS

    Turn the work into a reviewable next step.

    A study proposal, its assumptions and its evidence—ready for your experts.

    ↗
    BioMedAna ASSIST & AGENTS● LIVE · ILLUSTRATIVE WORKSPACE
    ASSIST & AGENTS / DECIDEEXAMPLE DATA
    Study factors0
    Conditions in study0
    Review statusDraft
    CANDIDATE STUDY Predicted titer · click to include or exclude
    FEED START (DAY)
    FEED RATE (g/L/day) →

    Day 3, 3 g/L/day: predicted 5.3 ± 0.30 g/L (illustrative)

    REVIEW GATE

    Ready for a scientist.
    Not the bioreactor.

    Confirm safe ranges, controls, randomization and statistical power.

    Illustrative data · expert review requiredASSIST & AGENTS / 03

    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.

    Skip card journey ↓
    Modeling across the lifecycle01 / 05 ↓ SCROLL TO EXPLORE
    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

    Evaluate digital twin options

    Read the hybrid digital twin guide before setting pilot acceptance criteria, then use the bioprocess digital twin validation checklist to define model scope and held-out tests.

    Explore AI-powered soft sensors for bioprocessing, AI for bioprocess scale-up and compare BioMedAna and Basetwo on hybrid modeling, evidence and review workflows.

    Common questions about BioMedAna Twin

    What is a bioprocess digital twin?

    It is a model of a process connected to relevant process evidence. Teams use it to test scenarios and estimate outcomes such as yield, quality or scale-up behavior within a defined use case.

    What makes BioMedAna Twin hybrid?

    BioMedAna combines process science and physics constraints with data-driven methods. Each model still needs validation on representative data and clear limits for its intended use.

    Can Twin control a manufacturing process automatically?

    BioMedAna positions Twin outputs as evidence-linked recommendations for human review. Any control integration or authorized action depends on deployment scope and governance.

    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 ↗

    Scientific AI governance: principles and evidence

    Read the FDA–EMA Good AI Practice white paper for the ten principles and a scientific review workflow, and the draft Annex 22 white paper for GMP scope, testing and lifecycle evidence.