BioXion Modules

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AI is not a module — it is a cross-platform intelligence layer

BioXion's AI operates as a context-aware intelligence layer embedded across every module — not as a standalone feature. It continuously evaluates program data, detects risks specific to your modality and development phase, scores readiness, and surfaces actionable signals. A dedicated Regional Intelligence layer handles country-specific regulatory requirements as overlays on the core FDA/EMA/ICH/Swissmedic backbone — so regional gaps surface automatically at the step level, without managing separate roadmaps per market. Powered by Claude API / Azure OpenAI Switzerland North. Swiss-hosted. Entity-masked. Non-GxP. Every AI output is fully explainable and traceable.

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One connected system — from first clinical batch to commercial supply

BioXion is built on a bidirectional linking model. CMC connects vertically to every operational module. Modules connect horizontally to each other. A quality event links to the CDMO batch it originated from. An analytical deviation links to the CMC step it affects. A supply risk links to the manufacturing campaign it threatens. This connected architecture is not limited to clinical development — BioXion is designed to remain the operational intelligence backbone through Phase III and into commercial manufacturing, post-approval changes, and product lifecycle management.

Phase 1 — In development

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Phase 1

CMC Development Navigator

The orchestration core of BioXion

CMC is not just one module — it is the primary orchestration layer that drives the entire platform. AI-generated development roadmaps span the full lifecycle from Preclinical through Commercial, covering Drug Substance, Drug Product, Analytical, and Regulatory workstreams. Every step carries regulatory context, document linkage, and AI evaluation scope. Supports all 9 therapeutic modalities with modality-specific intelligence — including a dedicated Gene Therapy track addressing viral vector-specific requirements that differ fundamentally from classical biologics. A Custom Modality option supports novel or user-defined development frameworks.

Small MoleculemAbADCmRNARecombinant ProteinViral Vector VaccineCell TherapyGene TherapyOligonucleotideCustom Modality

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Phase 1

AI Dashboard — Program Intelligence

The intelligence surface of the platform

The Overview dashboard is where BioXion's AI layer becomes visible. Program readiness is scored continuously based on the state of all connected data — with automatic escalation when critical risks are detected. Risk signals are prioritized by severity and phase context, with each signal fully explained and linked to the regulatory basis that triggered it. Cross-module impact propagates automatically: a risk in one area surfaces as a signal across all affected modules. The Regional Intelligence layer flags country-specific requirement gaps per step — without requiring separate workflows per market.

Readiness scoringRisk prioritizationRegional intelligenceCross-module signalsFull explainability

Phase 2 — Roadmap 2026

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Phase 2

CDMO Oversight

Contract Manufacturing Intelligence incl. Tech Transfer

Centralized oversight of all CDMO relationships — tech transfer milestones, GMP batch deliverables, audit findings, and risk status per partner and site. Fully linked to CMC steps and to Quality and Supply Chain modules. The AI Partner Reliability Index provides an objective, data-driven assessment of each CDMO partner — replacing subjective relationship management with quantified performance intelligence.

Tech transferAI Partner IndexGMP batchesAudit tracking

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Phase 2

Analytical Intelligence

Method Lifecycle Management

Full analytical method lifecycle — development, qualification, validation, tech transfer, and stability. Linked to CMC steps vertically and to Quality horizontally. AI monitors method performance in real time with modality-specific evaluation criteria, surfacing risks before they reach formal review cycles. Method transfer readiness is assessed automatically against destination site capabilities.

HPLC / LC-MSBioassayICH Q2(R2)Method transferStability

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Phase 2

Quality Intelligence

Quality Systems & Event Management

Unified view of deviations, CAPAs, change controls, and upcoming audits — each linked to the relevant CMC step, analytical method, or CDMO activity. Quality events propagate automatically as risk signals across all connected modules. AI distinguishes isolated incidents from systemic process signals — providing early warning that disconnected QMS tools cannot deliver.

DeviationsCAPAChange controlAudit readinessCross-module impact

Phase 3 — Planned 2027

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Phase 3

Regulatory Intelligence

Global Submissions, Compliance & Market Intelligence

Full submission portfolio management — IND, BLA, CTA, MAA, and CMC variations — across FDA, EMA, ICH, and Swissmedic, with regional market overlays. Each submission carries an AI Readiness Score linked directly to CMC step completion and module data. New regulatory guidance is monitored continuously and mapped to active submissions — flagging gaps before they become deficiencies at inspection or review.

FDA / EMA / SwissmedicAI Readiness ScoreRegional overlaysGuidance monitoring

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Phase 3

Supply Chain Intelligence

Inventory, Logistics, Cold Chain & Commercial Readiness

Real-time visibility into raw material availability, CDMO capacity, and supply risk mapped to the development and commercial program. Unlike point solutions, BioXion Supply Chain is designed to stay operational beyond clinical development — remaining the supply intelligence backbone through commercial manufacturing, post-approval change management, and product lifecycle. Linked horizontally to CDMO and CMC for end-to-end traceability.

CDMO capacityCold chainInventoryCommercial lifecycleDemand planning