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AiCuris Anti-Infective Cures AG

Lean R&D toward a 2026 filing

A German antiviral biotech running 70 global trial sites, managing external CDMOs and lab automation together

Industry
Anti-Infective Biopharma
Headquarters
Wuppertal, Germany
Public information as of
January 2026

A4BEE prepared this analysis from publicly available sources. It reflects our own reading of AiCuris Anti-Infective Cures AG's published strategy and is not endorsed by, or produced in cooperation with, AiCuris Anti-Infective Cures AG. Company website

Strategic priorities

AiCuris is a German biopharma focused on anti-infective drug development, headquartered in Wuppertal with subsidiaries in the US (AiCuris U.S. Inc.) and UK. The lead asset is Pritelivir, an antiviral for immunocompromised patients that received FDA Breakthrough Therapy Designation and is on track for an NDA submission in 2026. The pipeline includes AIC468, an antisense oligonucleotide platform. AiCuris operates without internal manufacturing — all production is outsourced to external CDMOs managed by the CMC and Supply Chain organisation.

The Wuppertal site houses high-throughput screening and synthetic biology platforms, including the CompuGene programme for computational gene design and a CyBio FeliX automated liquid handling system for sample preparation. Researchers spend up to 65 percent of their time on manual data collection and cleaning rather than scientific analysis — a significant productivity constraint in a lean organisation that cannot easily add headcount.

The 2026 NDA submission is the dominant business event. The FDA Breakthrough Therapy Designation creates an accelerated development path that makes regulatory data integrity non-negotiable. The challenge is maintaining 21 CFR Part 11-compliant audit trails across 70 global clinical trial sites while simultaneously modernising the Wuppertal R&D lab and integrating data from multiple external CDMOs — all within a lean organisation that has no manufacturing infrastructure of its own.

Challenges we see

  • Operations R&D Efficiency

    Researchers spending 65 percent of time on manual data collection instead of scientific analysis

    The Wuppertal high-throughput screening and synthetic biology platforms — including CompuGene and the CyBio FeliX automated liquid handler — still require significant manual sample preparation and data transcription steps. Critical biological KPIs are tracked in disconnected Excel spreadsheets rather than flowing automatically from instruments.

    When researchers spend the majority of their time on data collection and cleaning, the organisation's effective R&D capacity is a fraction of what it could be. A team of 10 researchers operating with automated data pipelines is more productive than a team of 15 running on spreadsheets.

  • Digital Supply Chain

    Manual reconciliation between CDMO data formats and internal QA standards

    As a virtual manufacturer with no internal production, AiCuris depends entirely on its CMC and Supply Chain teams to manage external CDMOs. The Tech Transfer phases require reconciling CDMO data formats with internal QA requirements — a process that currently runs on paper-based records and manual comparison.

    When CDMO batch records arrive in a format that does not automatically match internal QA requirements, the reconciliation process consumes CMC team time and introduces the risk that discrepancies are caught late rather than early — a particular risk in the months before an NDA submission.

  • Digital Integration

    Research data trapped in instrument-specific software and disconnected systems

    Research data at Wuppertal sits in instrument-specific software — the CyBio Composer platform, disconnected LIMS and ELN systems — that does not exchange data automatically. Cross-departmental data analysis requires exporting, reformatting, and manually combining datasets.

    When biological insight requires correlating data from the CyBio FeliX with gene expression data from a separate system, the time cost of the data assembly step means that not all correlations are attempted — limiting the scientific questions the organisation can ask.

  • Operations Infrastructure

    Air-gapped legacy lab instruments requiring manual USB data transfers

    Legacy laboratory instruments at Wuppertal use RS-232, early Profibus, or proprietary protocols and are not connected to cloud infrastructure. Data transfer between instruments and the central research database requires manual USB stick transfers — creating both cybersecurity risk and a manual process burden on researchers.

    When data transfer from a legacy instrument requires a USB stick, the instrument becomes a potential malware entry point into the research network, and the data from that instrument is always at least one manual step behind the data from connected instruments.

  • Compliance Regulatory

    Maintaining FDA-compliant audit trails across 70 clinical trial sites

    The FDA Breakthrough Therapy Designation for Pritelivir mandates an accelerated development path with 100 percent compliant ALCOA+ audit trails across all clinical sites. The 70 global clinical trial sites each generate data that must be incorporated into the NDA submission in a format that satisfies FDA scrutiny.

    When 70 clinical trial sites each use their own data management practices and the consolidation into an NDA submission package happens retrospectively, the risk is that data gaps, inconsistencies, or transcription errors are discovered during the submission preparation — with insufficient time to resolve them before the deadline.

Opportunities, by urgency and business impact

Each bubble is one opportunity, numbered to match the list below. Further right means it bites sooner; higher means a bigger effect on the business. A bigger bubble means a bigger implementation effort.

Source: A4BEE analysis of public sources

  1. Automated laboratory data capture and real-time KPI visualisation

    Researchers spend up to 65 percent of their time on manual data collection and cleaning rather than high-value scientific analysis, with critical biological KPIs tracked in disconnected Excel spreadsheets.

    Deploy automated data capture from laboratory instruments with real-time visualisation dashboards that integrate calculated biological metrics alongside sensor data — collapsing the data collection time burden and freeing researcher capacity for scientific analysis.

    • Wuppertal research platform operational analysis
    • CyBio FeliX and CompuGene platform documentation

  2. Industrial data platform integrating CDMO, Wuppertal, and clinical trial data

    The German R&D headquarters and the newly established US subsidiary operate on disconnected data architectures, while CDMO production data and clinical trial results sit in separate systems that cannot be viewed together.

    Build an ontology-based Industrial Data Platform serving as the Single Source of Truth, integrating LIMS data from Wuppertal, production data from CDMOs, and clinical trial results — providing unified visibility for the executive team and the data infrastructure for a clean NDA submission.

    • AiCuris CMC and Supply Chain organisation structure
    • 2026 Pritelivir NDA submission requirements

  3. Legacy instrument IoT gateway retrofitting for secure data acquisition

    Air-gapped legacy instruments in the Wuppertal labs cannot communicate with modern cloud systems, requiring manual USB data transfers that pose both security and efficiency risks.

    Deploy industrial IoT gateways supporting RS-232, Profibus, and Ethernet to move data directly from legacy instruments to a secure cloud environment without manual USB transfers — eliminating the security risk and the manual data transfer burden simultaneously.

    • Wuppertal legacy instrument inventory
    • RS-232 and Profibus connectivity specifications

  4. ALCOA+-compliant paperless clinical trial data environment

    Maintaining 100 percent compliant audit trails across 70 global clinical trial sites is a monumental task with current manual processes, creating regulatory risk for the Pritelivir NDA submission.

    Implement a paperless laboratory and clinical data environment with automated auditing capabilities that ensure real-time GxP compliance and ALCOA+ data integrity — providing FDA inspectors with an electronic record trail that is complete, consistent, and attributable from first data point to submission.

    • FDA Breakthrough Therapy Designation requirements for Pritelivir
    • 70-site clinical trial data management requirements

  5. MTP-based laboratory automation integration for the CompuGene platform

    The CyBio FeliX and CompuGene platform automation is siloed and requires custom scripting for any reconfiguration, limiting the pace at which researchers can reconfigure assays for new drug candidates.

    Standardise laboratory equipment using the NAMUR 2658 MTP standard to create Plug and Produce modularity, enabling researchers to reconfigure assays via drag-and-drop rather than rewriting code — reducing the specialist automation engineering dependency.

    • CyBio FeliX and CompuGene platform reconfiguration requirements
    • NAMUR 2658 MTP standard implementation case studies

What we'd propose

  • Digital Lab

    Industrial IoT Gateway Deployment for Wuppertal Legacy Instruments

    We deploy industrial IoT gateways at Wuppertal to connect legacy RS-232 and Profibus instruments to a secure cloud environment, enabling automated data acquisition from air-gapped equipment without requiring hardware replacement or USB transfers.

    • RS-232 and Profibus gateway deployment

      Legacy instruments connected without hardware replacement

      Install validated IoT gateway units on legacy laboratory instruments at Wuppertal — including RS-232-compatible devices, Profibus-connected equipment, and older instruments with proprietary protocols — that stream data directly to the secure cloud environment, replacing the manual USB transfer workflow with continuous automated data acquisition.

    • Cybersecurity isolation layer

      Air-gap maintained, data flows, threats blocked

      Implement a demilitarised zone architecture that allows data to flow from legacy instruments to the cloud while blocking inbound connections — maintaining the air-gap security model while eliminating the USB transfer that requires physical media crossing the security boundary.

    • Unified instrument data dashboard

      All instruments visible in one research dashboard

      Build a research dashboard that aggregates data from all connected Wuppertal instruments — new and legacy — into a single visualisation environment where researchers can see the status of all instruments, the data they are producing, and the experiments in progress, regardless of the protocol each instrument uses.

    • USB data transfers are eliminated, removing a malware entry point and freeing researchers from the manual data transfer workflow that interrupts their work multiple times per day.
    • Legacy instruments become first-class participants in the research data environment, contributing their data automatically to every analysis rather than requiring manual export.
    • The IoT gateway deployment is the foundation for the unified instrument dashboard that gives researchers a real-time view of all experiments across the Wuppertal site.

    We've done this before

    See how we do Digital Lab
  • Digital Lab

    MTP-Based Laboratory Automation Integration

    We implement the NAMUR 2658 Module Type Package standard across the CompuGene platform and CyBio FeliX automation to enable Plug and Produce modularity — reducing experimental setup times, eliminating custom scripting dependencies, and freeing specialist automation engineers for higher-value work.

    • MTP equipment packages for CyBio FeliX

      Automated liquid handler described in standard format

      Create MTP-compliant equipment packages for the CyBio FeliX liquid handling platform and the CompuGene gene design system, covering assay parameters, liquid class definitions, and workflow sequences — enabling assay reconfiguration through drag-and-drop rather than custom script writing.

    • Assay reconfiguration workspace

      Researchers reconfigure assays without specialist help

      Build an assay library and workflow editor that allows researchers to design, configure, and launch new assays on the CyBio FeliX using pre-validated MTP modules — reducing the lead time for a new assay configuration from days of specialist engineering work to hours of researcher configuration.

    • Automation engineer productivity dashboard

      Engineering capacity visible and optimisable

      Deploy a dashboard that tracks automation engineering utilisation across the Wuppertal site, identifying the highest-value projects for specialist engineering time and revealing which assay configurations have been absorbed into the MTP library and can be launched without engineering support.

    • The specialist automation engineering bottleneck is resolved because routine assay reconfigurations can be executed by researchers without engineering support — multiplying the effective capacity of the automation team.
    • Assay turnaround time decreases because the MTP library encodes institutional knowledge about the CyBio FeliX that was previously held by individual engineers.
    • The organisation's ability to respond to new drug candidates with rapid assay development is accelerated, directly supporting the pipeline expansion objectives.

    We've done this before

    See how we do Digital Lab
  • Enterprise AI

    Ontology-Based Industrial Data Platform for CDMO Integration

    We build an ontology-based Industrial Data Platform that serves as the Single Source of Truth for AiCuris — integrating LIMS data from Wuppertal, production data from external CDMOs, and clinical trial results into a unified architecture that provides the data infrastructure for the 2026 NDA submission.

    • CDMO data connector library

      All CDMO data streams connected regardless of format

      Build validated data connectors for each external CDMO's data export formats, mapping production batch records, in-process analytics, and quality results into the unified ontology — so that CDMO data is available in AiCuris's internal format without manual reformatting.

    • Wuppertal LIMS and ELN integration

      R&D data from Wuppertal unified with CDMO and clinical data

      Integrate the Wuppertal LIMS and ELN systems into the ontology-driven data platform, connecting the CompuGene platform, CyBio FeliX results, and gene expression data with CDMO production data and clinical trial results — creating the unified research view that the NDA submission preparation requires.

    • Clinical trial data aggregation for NDA submissions

      70-site data in one submission-ready format

      Configure a clinical data aggregation layer that ingests data from all 70 global clinical trial sites, normalises it to the required submission format, and presents it for NDA submission package assembly — reducing the retrospective data compilation effort that currently creates timeline risk before the submission deadline.

    • The CMC team's CDMO reconciliation work is reduced because CDMO data arrives in AiCuris's internal format automatically rather than requiring manual comparison and reformatting.
    • The NDA submission data package is assembled from a structured database rather than compiled retrospectively from 70 sites' disparate data management practices — eliminating the data consolidation risk that appears in the months before a submission deadline.
    • Executive visibility into the Pritelivir development programme improves because CDMO production data, Wuppertal research data, and clinical trial results are accessible in one place rather than requiring separate queries to each data source.

    We've done this before

    See how we do Enterprise AI
  • Digital Lab

    Real-Time Process Intelligence and Research KPI Visualisation

    We implement a comprehensive data intelligence layer that automates the calculation of critical biological KPIs and presents them through high-performance dashboards — aligned with laboratory P&ID layouts — enabling researchers to monitor experiment status and biological metrics in real time.

    • Automated KPI calculation engine

      Biological metrics calculated automatically from raw data

      Build a KPI calculation engine that ingests raw instrument data and automatically computes the biological metrics that researchers currently calculate by hand — cell viability, gene expression coefficients, enzyme activity rates — eliminating the manual calculation step that currently consumes significant researcher time.

    • Research experiment dashboard

      Every active experiment visible on one screen

      Deploy a real-time research dashboard that shows the status of all active experiments across Wuppertal — instruments running, samples in queue, results trending, KPI values versus expected ranges — enabling researchers to see the full picture of the lab's activity without visiting each instrument.

    • Cross-assay correlation analysis

      Correlations across instruments found automatically

      Configure an automated correlation engine that identifies relationships between data from different instruments — correlating gene expression results from the CompuGene with cell viability data from the CyBio FeliX — surfacing insights that would not be found in a single-instrument analysis.

    • Researcher time spent on manual data collection and cleaning decreases from 65 percent of their working hours toward the 20-30 percent that organisations with automated data pipelines achieve — a significant productivity gain in a lean organisation.
    • The correlation engine surfaces biological insights that would not be found by examining each instrument's data in isolation — accelerating the scientific discovery cycle.
    • The real-time experiment dashboard gives lab management visibility into utilisation and throughput that was previously unavailable, enabling better resource allocation decisions.

    We've done this before

    See how we do Digital Lab
  • Digital Lab

    GxP-Compliant Paperless Clinical and Research Data Environment

    We deploy a paperless laboratory and clinical data environment meeting ALCOA+ requirements across Wuppertal and all 70 clinical trial sites — providing 100 percent attributable, complete, consistent, and timely electronic records that satisfy FDA 21 CFR Part 11 requirements for the Pritelivir NDA submission.

    • Electronic clinical record deployment at 70 sites

      Every clinical site on electronic records, not paper

      Implement validated electronic data capture at all 70 clinical trial sites, covering patient data entry, sample tracking, and study outcome recording — replacing paper-based data collection with structured electronic records that automatically satisfy ALCOA+ requirements from the first entry.

    • Real-time ALCOA+ compliance monitoring

      Data integrity issues flagged at the time they occur

      Configure automated ALCOA+ compliance monitoring that flags missing data, out-of-range values, and attribution gaps at the time they occur rather than at the end-of-study data review — enabling corrective actions while the clinical sites are still active.

    • NDA submission package generator

      Submission data compiled from validated electronic records

      Build an NDA data package generator that extracts clinical trial data from the validated electronic records and formats it into the structure required by FDA for a Breakthrough Therapy NDA submission — reducing the retrospective compilation effort that creates timeline risk.

    • The Pritelivir NDA submission is protected from data integrity findings because every clinical site is on validated electronic records — FDA inspectors reviewing the ALCOA+ compliance of 70 sites' data are reviewing a consistent, auditable system rather than paper records of varying quality.
    • The retrospective data compilation risk that typically appears in the months before a submission deadline is eliminated because the NDA data package is a retrieval from a validated database rather than an assembly from disparate sources.
    • The Wuppertal research lab benefits from the same paperless infrastructure, reducing the manual transcription errors that currently affect research data quality.

    We've done this before

    See how we do Digital Lab

Digital maturity: today and target

Scored out of 100 across six dimensions. The target is what AiCuris Anti-Infective Cures AG's own published ambition implies — not a perfect score.

Source: A4BEE analysis of public sources
Data Integration 35 → 85
Research data at Wuppertal sits in instrument-specific software and disconnected LIMS/ELN systems. CDMO production data and clinical trial results are in separate systems. The ontology-based data platform that would serve as the Single Source of Truth does not yet exist — data integration requires manual export, reformatting, and combination by researchers.
Process Automation 45 → 90
The CyBio FeliX automated liquid handler and CompuGene platform are operational but require custom scripting for any reconfiguration. Researchers spend 65 percent of their time on manual data collection and cleaning rather than scientific analysis — the productivity gap between the current state and what automated data pipelines would deliver is substantial.
Cybersecurity 40 → 85
Legacy instruments requiring USB data transfers create an air-gap violation each time a USB stick is used. The Wuppertal lab network is increasingly a target for industrial espionage — the combination of air-gapped instruments and manual USB transfers represents a cybersecurity risk that has not been formally assessed or mitigated.
Regulatory Compliance 55 → 95
Clinical trial data is collected across 70 global sites with varying degrees of electronic data capture maturity. The FDA Breakthrough Therapy Designation creates heightened scrutiny of data integrity. The paperless, ALCOA+-compliant data environment required for the NDA submission has not yet been implemented.
Lab Equipment Connectivity 30 → 80
A significant proportion of Wuppertal laboratory instruments are not connected to the research data network. The IoT gateway programme has not begun, and the legacy RS-232 and Profibus instruments remain air-gapped — each representing both a data integration gap and a cybersecurity vulnerability.
Analytics and Visualisation 40 → 85
Critical biological KPIs are tracked in Excel spreadsheets and disconnected instruments. No real-time research dashboard exists. Researchers who want to see the status of all active experiments must visit each instrument individually rather than accessing a consolidated view.

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This is an independent analysis prepared by A4BEE from publicly available information as of January 2026. It reflects A4BEE's own interpretation and opinion, is not affiliated with, endorsed by, or verified with AiCuris Anti-Infective Cures AG, and may be incomplete or inaccurate. All company names and trademarks are the property of their respective owners. To request a correction or removal, contact [email protected].