BioMedAna OS · OPERATING LAYER

Deploy BioMedAna securely across sites and teams.

BioMedAna OS governs BioHub, Bio Twin and BioAgents with shared security, evidence lineage, review and deployment controls across sites, programs and teams.

Discuss a deployment ↗See the capabilities ↓

BioMedAna OSOne operating layer

BioHubEvidence

Bio TwinModels

BioAgentsWork

AllowedTwin model v2.1 promoted after held-out evaluation

✓ Access control✓ Data provenance✓ Model lifecycle✓ Human review✓ Audit trails✓ Multi-site ready✓ Multi-program ready✓ SOC 2 compliant

01 — OS CAPABILITIES

One operating layer.
Every deployment.

OS provides shared security, governance, deployment and collaboration controls for BioHub, Bio Twin and BioAgents across sites, programs and teams.

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The OS operating layer01 / 06 ↓ SCROLL TO EXPLORE

01Security

SOC 2 compliant platform foundation, access control and controlled environments.

02Governance

Evidence lineage, model versioning, approval workflows and audit trails.

03Deployment

Meet the process where it lives — connect existing sources without a rip-and-replace program.

04Multi-site collaboration

Consistent workspaces, roles and evidence across sites and teams.

05Multi-program & CDMO

Client and program isolation with reusable knowledge across a shared platform core.

06Model lifecycle

Version-aware model releases, drift monitoring and controlled rollout.

02 — ONE RELATIONSHIP

One name.
One relationship.

BioMedAna OS is the operating layer for BioHub, Bio Twin and BioAgents, governing security, deployment, collaboration and model lifecycle across the platform.

Explore trust & compliance ↗

01Hub + Twin + Agents, governed

OS applies a consistent set of controls across the connected products.

02Multi-site, multi-program

Consistent roles and isolation across sites, clients and programs.

03Model lifecycle

Versioning, drift monitoring and controlled rollout.

ONE PLATFORMBioMedAnaConnected intelligence

SELECT A CAPABILITY · EXPLORE THE CONNECTIONS

CONNECT THE EVIDENCE

Hub

Bring run histories, assays, process events and source records into shared scientific context.

Source lineage
Run context
Connected records

Explore Hub ↗

8 MODALITIES · ONE GOVERNED FOUNDATION

Keep every program in its scientific context.

From viral vaccines to chemical APIs, preserve program boundaries, source lineage, model versions and expert review. For vaccine programs, connect cell-bank and seed-virus identity with infection, harvest, recovery and inactivation evidence.

CHO · mAbMonoclonal antibodies CHO · MicrobialRecombinant proteins CAR-T · TIL · NKCell therapies AAV · LentiviralGene therapies and viral vectors Bacterial · YeastMicrobial and precision fermentation ASO · siRNARNA and oligonucleotides Small molecule · Reaction kineticsChemical & pharmaceutical APIs VAX · Cell cultureViral vaccines

Workflow availability and model suitability are evaluated for the product, process and intended use. Scientific and quality decisions remain with your team.

03 — PLATFORM CONTROLS

Practical controls.
Not a compliance slogan.

OS makes these controls consistent across every site, program and team using BioMedAna — the same six controls apply whether you run one site or twenty.

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Platform controls in context01 / 06 ↓ SCROLL TO EXPLORE

Identity & access

Role-based access, least privilege and controlled workspaces.

SSO/SAML, per-site workspaces, scoped permissions by role

Data provenance

Source-to-decision lineage for records, calculations and model outputs.

Every field traces to its source system, transform and reviewer

Model lifecycle

Version-aware configurations, review history and controlled releases.

Versioned releases, rollback, drift monitoring and change log

Human review

Evidence and approval context before consequential scientific action.

Approval gates on Twin recommendations before they inform a decision

Operational resilience

Monitored service operations, backups and recovery practices.

Monitored uptime, automated backups and documented recovery

Environment control

Clear separation between development, validation and production contexts.

Isolated dev, validation and production workspaces per deployment

04 — SHARED RESPONSIBILITY

Clear platform controls.
Clear customer ownership.

OS provides the platform safeguards; each site or program retains responsibility for intended use, validation scope, access policy and regulated procedures.

BioMedAna OS PROVIDESSITES & PROGRAMS GOVERN

Secure platform and service operations

Intended use and risk classification

Workspace, role and access controls across sites

Validation and qualification strategy

Evidence, model and decision lineage

User access, procedures and retention

System activity and review mechanisms

Final scientific and quality decisions

05 — DEPLOYED WITHOUT A RIP-AND-REPLACE

Value in weeks.
Not a year-long transformation.

OS is designed to meet data where it already lives, configure around each site’s process, and deliver measurable value without requiring a platform overhaul.

TYPICAL ENTERPRISE ROLLOUT8–12+ monthsNew platform layer across teams

BioMedAna TARGET8–12 weeksTo initial, measurable value

W1W2W3W4W5W6W7W8W9W10W11W12

ConnectWEEKS 1–2

Priority sources connected, read-only, in your environment

ContextualizeWEEKS 2–5

Runs, materials, events and assays aligned into scientific records

First modelsWEEKS 5–9

Baseline predictions validated against held-out historical runs

Governed decisionWEEKS 9–12

First evidence-linked recommendation reviewed in a real workflow

ILLUSTRATIVE 12-WEEK SHAPE — SCOPE AGREED PER DEPLOYMENTMilestone: first governed, evidence-linked decision ✓

06 — BUILT AROUND YOUR ORGANIZATION

Single site.
Or multi-program CDMO.

01Single-site organizations

One governed workspace across Process Development, MSAT and Manufacturing

02Multi-site organizations

Consistent roles, controls and evidence across every site

03CDMO & multi-program

Client and program isolation with reusable platform-level intelligence

WHY BioMedAna

Others solve pieces.
BioMedAna contextualizes the process.

Integration alone does not make a scientific record. A model alone does not make a decision. BioMedAna connects the full intelligence journey—from real-time evidence to governed action.

Connect

Live process + historical evidence

→

Contextualize

Modality-native process semantics

→

Predict

Physics + AI/ML + domain science

→

Decide

Evidence-linked, human-governed action

→

Traditional approach

BioMedAna

Platform-first implementation

Outcome-led engagement, starting from one decision

One-size-fits-all workflows

Configured for your modality and your data

Black-box predictions

Evidence-linked, physics-constrained AI

Dashboards & point analytics

Connect, contextualize, predict and act

Another data destination

Works with your existing data estate

Fragmented tools & tribal knowledge

One intelligence layer across teams

8–12+ month implementation cycles

Target initial value in 8–12 weeks

BioMedAna is designed to meet data where it already lives, configure around your process, and deliver measurable value without a rip-and-replace transformation.

Scientific depth. Connected execution.

The capabilities your teams need across the bioprocess lifecycle, compared with the tool categories they usually come from.

What your teams need	Data platforms	Digital twin tools	AI / ML platforms	Agent / workflow tools	BioMedAna
Reduce data-preparation effortConnected, contextualized evidence	Core	Varies	Varies	Varies	Hub
Focus experimentationDoE, hypotheses and experiment planning	Varies	Core	Varies	Varies	Twin + Agents
Understand and optimize process behaviorPhysics + biology + data + ML	Varies	Core	Core	Varies	Twin
Strengthen scale-up and transferSimulation, comparability and risk analysis	Varies	Core	Varies	Varies	Hub + Twin + Agents
Investigate manufacturing variabilityPAT, chromatography and batch analysis	Varies	Varies	Varies	Varies	Hub + Twin + Agents
Advance Quality and CMC readinessEvidence mapping, investigations, review packs	Varies	Varies	Varies	Varies	Hub + Agents
Expand team capacitySpecialist agents and authorized execution	Varies	Varies	Varies	Core	Agents
Apply modality-specific intelligenceScientific context, models and workflows	Varies	Varies	Varies	Varies	Hub + Twin + Agents
Coordinate work with oversightIntegration, governance and traceability	Varies	Varies	Varies	Varies	OS

Core = typical category focus. Varies = offering- and implementation-dependent. BioMedAna entries identify the principal contributing offerings. Illustrative category comparison, not a vendor-by-vendor assessment.

07 — QUESTIONS WE GET OFTEN

Straight answers before the pilot.

Is OS a separate product from Hub, Twin and Agents?

No. OS is the operating layer that surrounds BioHub, Bio Twin and BioAgents. It governs their security, access, deployment and lifecycle rather than holding scientific data on its own.

Can OS isolate data across sites or clients?

Yes. OS supports workspace and tenant isolation for multi-site organizations and CDMO/multi-program deployments, while still allowing platform-level intelligence to be reused where appropriate.

Does OS replace our existing IT and security stack?

No. OS is designed to operate within existing identity, network and security architecture rather than replace it.

Plan governance around the scientific workflow

Use the bioprocess data-readiness checklist to map source ownership and traceability, and the digital twin validation guide to define intended use and model review.

Explore technology transfer and PPQ evidence handoffs and how connected platform governance supports data, models and agents.

Start with one deployment

Map the sites, teams and controls BioMedAna OS needs to support.

We will define the security, governance and deployment path required for your organization.

Talk to BioMedAna ↗

Deploy BioMedAna securely across sites and teams.

One operating layer.
Every deployment.

Workspace permissions

Evidence lineage

Connect the existing estate

Cross-site collaboration

Program boundaries

Model release history

One name.
One relationship.

Hub

Keep every program in its scientific context.

Practical controls.
Not a compliance slogan.

Identity & access

Workspace permissions

Data provenance

Evidence lineage

Model lifecycle

Model release history

Human review

Approval workflow

Operational resilience

Operational readiness

Environment control

Environment boundaries

Clear platform controls.
Clear customer ownership.

Value in weeks.
Not a year-long transformation.

Single site.
Or multi-program CDMO.

Others solve pieces.
BioMedAna contextualizes the process.

Scientific depth. Connected execution.

Straight answers before the pilot.

Is OS a separate product from Hub, Twin and Agents?

Can OS isolate data across sites or clients?

Does OS replace our existing IT and security stack?

Plan governance around the scientific workflow

Map the sites, teams and controls BioMedAna OS needs to support.

Deploy BioMedAna securely across sites and teams.

One operating layer.Every deployment.

One name.One relationship.

Hub

Keep every program in its scientific context.

Practical controls.Not a compliance slogan.

Identity & access

Data provenance

Model lifecycle

Human review

Operational resilience

Environment control

Clear platform controls.Clear customer ownership.

Value in weeks.Not a year-long transformation.

Single site.Or multi-program CDMO.

Others solve pieces.BioMedAna contextualizes the process.

Scientific depth. Connected execution.

Straight answers before the pilot.

Is OS a separate product from Hub, Twin and Agents?

Can OS isolate data across sites or clients?

Does OS replace our existing IT and security stack?

Plan governance around the scientific workflow

Map the sites, teams and controls BioMedAna OS needs to support.

One operating layer.
Every deployment.

One name.
One relationship.

Practical controls.
Not a compliance slogan.

Clear platform controls.
Clear customer ownership.

Value in weeks.
Not a year-long transformation.

Single site.
Or multi-program CDMO.

Others solve pieces.
BioMedAna contextualizes the process.