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Biomay AG

Connecting two CDMO sites from source to scientist

Industry
CDMO for microbial biopharmaceuticals (plasmid DNA, mRNA, recombinant proteins)
Headquarters
Vienna, Austria
Public information as of
February 2026

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

Strategic priorities

Biomay opened the 4,000-square-metre Seestadt headquarters in 2022 as a tenfold increase in microbial manufacturing capacity, with parallel suites from 3-litre single-use bioreactors for personalised batches up to 750-litre stainless steel runs for commercial supply. The October 2023 expansion of the downtown mRNA Competence Center added end-to-end mRNA and LNP (lipid nanoparticle) formulation services on a second Vienna site.

In April 2025 the company received FDA approval for recombinant Cas9 nuclease manufacturing at the Seestadt site, qualifying it as a cGMP (current Good Manufacturing Practice) supplier for the US gene-editing market and following its 2021 role as a DNA template supplier for the Pfizer-BioNTech COVID-19 vaccine. Biomay joined the Alliance for mRNA Medicines in 2024 and launched GMP (Good Manufacturing Practice) LNP services in March 2025.

The Manufacturing Science and Technology (MSAT) team runs process and analytical development that has to translate into cGMP batch records across two manufacturing footprints. The operational priority is letting data from bioreactors, chromatography skids and analytical instruments at either site reach the MSAT and quality organisations in the same structure, so scale-up, tech-transfer and release work can run from a shared view rather than from reconciled extracts.

Challenges we see

  • Operations Manufacturing

    Scheduling parallel suites from 3L personalised to 750L commercial runs

    The Seestadt facility runs four simultaneous 3-litre single-use bioreactor suites for personalised batches in parallel with 750-litre stainless steel fermentation and downstream suites, while the downtown mRNA Competence Center adds another set of process and fill-finish capacity. Resource and suite scheduling now sits across hundreds of operations per week.

    When scheduling lives in spreadsheets and shared files, the room for conflicting bookings and last-minute shuffles scales with the number of parallel suites, so the predictability of every campaign depends on whatever tooling the planning team happens to be using.

  • Digital Integration

    Reading process data across bioreactors, chromatography and analytical instruments

    Process data is generated by bioreactors, chromatography systems, weight terminals and analytical instruments from several manufacturers across the two Vienna sites. Each equipment class typically exports to its own vendor software, and there is no public evidence of an enterprise MES (Manufacturing Execution System) or fully integrated eBR (electronic Batch Record) layer.

    Where each instrument family keeps its data in its own export, the work of combining a run into one reviewable record is paid for again at every hand-off, and the cost rises with the number of equipment classes involved.

  • Operations Operations

    Bringing fifty-plus new staff onto cGMP operations

    Headcount has nearly doubled to around 100 employees following the Seestadt expansion. Onboarding more than fifty new people into a cGMP-regulated environment is a recurring programme rather than a one-off project.

    Where training relies on shadowing and on-the-job explanation, the time each experienced person spends bringing new staff up to speed reduces the time they can spend on the work only they can do, and the gap between onboarding intent and recorded competence is hard to measure.

  • Digital Integration

    Connecting older equipment at the downtown mRNA site without compromising security

    The downtown mRNA Competence Center was expanded and reconstructed in 2023, mixing older equipment with newer systems. Bridging air-gapped units to the central data platform has to satisfy IEC 62443 (the industrial cybersecurity standard) and the NIS2 directive on network and information security.

    Where legacy equipment is read by hand or by USB stick, every transfer is a manual control point outside the documented system, which becomes harder to defend as the connected estate grows.

  • Compliance Regulatory

    Sustaining audit-ready cGMP operations across ten times the volume

    Biomay received FDA approval for Cas9 nuclease manufacturing in April 2025 and previously supported the Pfizer-BioNTech COVID-19 vaccine as a DNA template supplier. Passing the FDA inspection without observations and holding that outcome while volumes rise is a stated focus for the QA leadership.

    As the volume of work that has to be documented rises with capacity, the time available for review and the time consumed by documentation compete for the same specialist hours, and the bottleneck tends to move toward the review rather than the underlying work.

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. Simulating IVT runs before they reach the GMP floor

    The MSAT team is responsible for technology transfer from process development into cGMP manufacturing, but its current toolkit does not include simulation of In-Vitro Transcription (IVT) reactions, the enzymatic step that converts a DNA template into mRNA. Failed wet-lab experiments and long tech-transfer cycles are the visible consequence.

    A digital twin of the IVT step that encodes capping efficiency, polydispersity and encapsulation efficiency lets the MSAT team test scale-up and parameter changes virtually before committing to GMP runs, so wet-lab effort is spent on the experiments most likely to succeed.

    • Biomay mRNA services page, biomay.com/products/mrna
    • Biomay Manufacturing Science and Technology team profile, biomay.com/company/management-team

  2. Unifying process data from both Vienna sites

    Bioreactors, chromatography skids and analytical instruments at the Seestadt and downtown mRNA facilities export into separate vendor packages, and there is no shared ontology or pipeline that lets MSAT, manufacturing and QA see the same run in the same terms.

    An ontology-driven industrial data platform that defines assay, run, batch, lot and instrument once and then loads both sites against it gives MSAT, manufacturing and quality a single source of truth, so cross-site questions are answered from one query rather than per-site extracts.

    • Biomay facilities and capacities, biomay.com/company/facilities
    • Biomay Manufacturing Science and Technology team profile

  3. Bridging older equipment at the mRNA site into the connected estate

    Equipment at the downtown mRNA Competence Center predates the modern OPC UA (Open Platform Communications Unified Architecture) standard, and the absence of documented connectivity means data is read manually or by USB stick and the equipment sits outside the OT (Operational Technology) network.

    A documented retrofit pattern that puts older equipment on the network through a hardened gateway, with protocol translation and IEC 62443 segmentation, brings the data into the shared model without changing the equipment or weakening the security posture.

    • Biomay facilities and capacities, biomay.com/company/facilities
    • Closed connectivity solution, a4bee.com article

  4. Running a paperless QC laboratory with instrument-direct capture

    Quality control at Biomay relies on manual cell counting, paper logbooks and isolated spreadsheets for critical analytical steps. Each transfer between instrument, logbook and Excel is a separate point to type, to check and to defend during an inspection.

    Instrument-direct capture into a Laboratory Execution System (LES) with automated cell counting and an electronic batch record replaces paper-based steps with their own audit trail, so release decisions are traced back to the analytical run rather than reconstructed for an inspector.

    • Biomay quality assurance leadership profile, biomay.com/company/management-team
    • From paper to performance: operational efficiency and compliance in labs, a4bee.com article

  5. Building modular MTP-compliant automation libraries

    Modular manufacturing using MTP (Module Type Package, the VDI/VDE/NAMUR 2658 standard for plug-and-produce process modules) and OPC UA is becoming the reference for flexible biomanufacturing. Building each new automation configuration from project-specific code makes every change a small engineering project.

    A reusable MTP-compliant module library with an OPC UA backbone means new process skids are assembled from tested modules, which shortens the engineering effort for each reconfiguration and aligns Biomay's automation with the standards the Alliance for mRNA Medicines is shaping.

    • Biomay Alliance for mRNA Medicines membership announcement, biomay.com news
    • Accelerating lab and manufacturing operations with MTP, a4bee.com article

What we'd propose

  • Digital Lab

    IVT digital twin for MSAT scale-up

    A process twin of the In-Vitro Transcription step that lets the MSAT team run virtual experiments on capping efficiency, polydispersity and encapsulation efficiency before committing to a cGMP batch.

    • Process simulation engine

      Virtual IVT runs

      Build a model of the IVT reaction that accepts template sequence, enzyme mix and process parameters and returns predicted yield and quality attributes, calibrated against historical Seestadt runs.

    • Golden batch overlay

      Compare against best runs

      Overlay a current run's process trajectory against the best historical profile so deviation from the golden batch is visible during the run, not only in the post-batch report.

    • Scenario testing interface

      Pre-GMP what-ifs

      Give MSAT scientists a tool to simulate scale-up from 3-litre to 750-litre conditions and to compare parameter sets side by side before recommending a tech-transfer campaign.

    • MSAT effort is spent on the experiments most likely to succeed rather than on wet-lab failures.
    • Scale-up scenarios are compared in silico before they enter the GMP suite.
    • Tech-transfer recommendations carry a traceable evidence base from the moment they are issued.

    We've done this before

    See how we do Digital Lab
  • Enterprise AI

    Ontology-driven data platform across both Vienna sites

    A single industrial data platform built on an agreed ontology for assay, run, batch, lot and instrument, so data from bioreactors, chromatography skids and analytical instruments at Seestadt and the mRNA Competence Center load into one shared model.

    • Shared biomanufacturing ontology

      One agreed set of terms

      Define assay, run, batch, lot and instrument as explicit entities with documented relationships, so a query written once returns comparable answers across both sites rather than two dialects of the same table.

    • Vendor-agnostic data ingestion

      Load from every instrument

      Connect bioreactors, chromatography systems and analytical instruments through OPC UA (Open Platform Communications Unified Architecture), MQTT and documented vendor drivers, with schema validation at the boundary so bad records fail loudly instead of silently.

    • Cross-site analytics layer

      Questions answered without tickets

      Expose the model through dashboards and a retrieval layer so MSAT, manufacturing and quality can ask questions of the combined data set without commissioning a new extract for each one.

    • Integration work is done once against a shared model instead of once per point-to-point interface.
    • Cross-site questions on yield, quality and utilisation are answered from one query.
    • New assays and equipment attach to the model rather than triggering another migration.

    We've done this before

    See how we do Enterprise AI
  • Digital CDMO

    Secure retrofit for legacy equipment at the mRNA site

    A documented retrofit pattern that puts older equipment at the downtown mRNA Competence Center on the network through a hardened gateway, with IEC 62443 segmentation and a protocol translation layer.

    • Hardened OT gateway

      Air-gap bridging with documented security

      Deploy a gateway that brokers the connection between legacy equipment and the data platform, with documented zones and conduits so the security posture can be reviewed rather than re-argued later.

    • Protocol translation layer

      Older protocols, modern transport

      Translate proprietary and serial protocols into OPC UA or MQTT so legacy equipment publishes data in the same form as newer instruments, without forcing a controller replacement.

    • IEC 62443 segmentation

      Zones from day one

      Define zones, conduits and remote-access rules to IEC 62443 before commissioning, so the mRNA site's security posture is shaped by design rather than added after the fact.

    • Older equipment joins the shared data model without a controller replacement.
    • Manual USB transfers and undocumented connections are replaced by a documented control point.
    • The same retrofit pattern is reusable as the Seestadt fleet ages and gets upgraded.

    We've done this before

    See how we do Digital CDMO
  • Digital Lab

    Paperless QC laboratory with instrument-direct capture

    A Laboratory Execution System (LES) that connects balances, plate readers, cell counters and chromatography data systems to the electronic batch record, with automated cell counting as the visible first step.

    • Instrument integration

      Results captured at source

      Connect balances, plate readers, cell counters and chromatography systems so analytical results arrive with instrument identity, method version and timestamp attached, instead of being read off a screen and typed into another system.

    • Electronic batch record

      Digital GxP documentation

      Write the analytical result into the batch record as data with its own lineage, so each release decision is traced back to the specific analytical run that produced it.

    • Real-time compliance checks

      Preventive rather than detective

      Verify analyst training and instrument calibration status in real time before allowing a critical step to be recorded, so the GxP (Good Practice) check happens at the point of work rather than during an inspection.

    • Paper logbooks and manual transcription steps are replaced by data with its own audit trail.
    • Release evidence is generated at the bench rather than assembled for an inspection.
    • Cell counting and similar repetitive QC tasks move from a manual bottleneck to an automated step.

    We've done this before

    See how we do Digital Lab
  • Agents

    AI agents for tech-transfer and batch record drafting

    Narrow, reviewable agents that take the document-assembly load off MSAT and QA: drafting tech-transfer reports from source records, checking batch record completeness against the template, and tracing every change a standards update touches. A named reviewer approves every output.

    • Drafting from source records

      First drafts from system data

      Generate the first draft of a tech-transfer report or a batch record section directly from the underlying process and analytical records, so the author edits and judges rather than assembles.

    • Template and completeness checking

      Gaps found before review

      Check a submitted batch record or tech-transfer report against its template and the site's own checklist, returning missing or inconsistent sections before it enters the human review queue.

    • Change impact search across the document set

      Which documents a change touches

      When a specification, method or standard changes, retrieve every controlled document that references it and rank them by how directly they are affected, so the update scope is known on day one.

    • MSAT and QA reviewers spend their time on judgement calls rather than on assembling first drafts.
    • The scope of a standards change is established by search rather than by recollection.
    • Every output is traceable to the source records it came from and signed off by a named reviewer.

    We've done this before

    See how we do Agents

Where QB Systems fits

Alongside our services we build QB Systems, hardware and software for bioprocess control. QB Systems is a product brand of A4BEE Sp. z o.o.

Applications
Bioreactors

Software-defined control for a bioreactor — a new QB vessel, an upgrade to one you have, or a retrofit of the existing PLC.

Deployment
Hybrid connectivity

QB talks to equipment already in place over OPC-UA or Modbus, leaving the vendor's own control in charge.

Scale
Pilot (50–300 L)

Stainless steel, where QB supplies the control software and integration and a certified partner builds the installation.

Digital maturity: today and target

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

Source: A4BEE analysis of public sources
Data integration 35 → 82
Process data lives in vendor-specific exports across both Vienna sites, and there is no public evidence of an enterprise MES or unified eBR layer. The shared-model work is ahead of the operation rather than behind it.
Process automation 45 → 78
Seestadt runs modern bioreactors and chromatography skids, but scheduling and release still rest on spreadsheet and paper-based steps. The opportunity is to extend the equipment automation outward into the surrounding documentation and decision flow.
IT/OT convergence 30 → 72
The Seestadt site is largely new and connectable, while the downtown mRNA Competence Center mixes older air-gapped equipment with newer systems. Closing that gap is what makes a cross-site view possible.
Digital twin capability 20 → 65
MSAT currently relies on wet-lab experimentation for IVT scale-up and tech-transfer. Adding a calibrated IVT twin is the first step on a multi-stage digital-twin roadmap.
Regulatory digitization 40 → 85
FDA approval for Cas9 manufacturing was received in April 2025, and the QA organisation is investing in paperless lab and electronic batch record work to keep audit-readiness while volume rises tenfold.
Modular automation standards 25 → 70
The Alliance for mRNA Medicines membership and the modular direction of biomanufacturing make MTP and OPC UA the natural target, but the installed library of compliant modules is still small.

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This is an independent analysis prepared by A4BEE from publicly available information as of February 2026. It reflects A4BEE's own interpretation and opinion, is not affiliated with, endorsed by, or verified with Biomay 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].