Sandoz AG
Standalone IT/OT infrastructure for an independent pharmaceutical champion
- Pharmaceuticals (Generic and Biosimilar Medicines)
- Basel, Switzerland
- January 2026
A4BEE prepared this analysis from publicly available sources. It reflects our own reading of Sandoz AG's published strategy and is not endorsed by, or produced in cooperation with, Sandoz AG. Company website
Strategic priorities
Sandoz AG is a global leader in generic and biosimilar medicines, headquartered in Basel, Switzerland, and operating manufacturing sites across Poland, Slovenia, Austria and India. In October 2023, it completed its legal separation from Novartis — a USD 20+ billion spin-off that left Sandoz to operate independently for the first time in decades. The separation came with USD 581 million in separation and transformation costs in 2024 alone, driven primarily by the need to exit Transitional Service Agreements (TSAs) with Novartis for critical IT and OT support, rebuild or replace enterprise systems, and establish independent cybersecurity operations.
The immediate operational challenge is dual: Sandoz must continue running its high-volume manufacturing network — including the Stryków site producing 5 billion tablets per year and the Warsaw site running 21 product types across 12 lines — while simultaneously absorbing production from three recently closed manufacturing facilities. The technology debt accumulated during the Novartis era means that legacy equipment at multiple sites lacks modern connectivity, creating data islands where production information is trapped in local SCADA screens or spreadsheets.
Sandoz has committed USD 350 million to a multi-year transformation programme targeting 24-26% EBITDA margins and USD 1.1 billion in vertical integration investment for biosimilar manufacturing in Slovenia. Against this backdrop, the digital priorities are clear: exit TSA dependency with independent high-availability infrastructure, connect legacy equipment for real-time OEE visibility, enable operators with modern UX, establish industrial cybersecurity across the OT network, and automate ESG monitoring to support Net Zero 2050 commitments.
-
01
Biosimilars Growth Engine
Drive 30% sales growth through a 28-molecule biosimilar pipeline and USD 1.1B investment in end-to-end biosimilar manufacturing capacity in Slovenia, targeting a USD 300B market opportunity over the next decade.
-
02
Operational Excellence and Margin Expansion
Reduce manufacturing sites from 18 to 15, achieve 24-26% EBITDA margin through automation and Industry 4.0 process standardisation across Polish manufacturing sites, and absorb production from consolidated facilities.
-
03
Vertical Integration and Supply Chain Control
Maintain competitive advantage through in-house API production, finished dosage manufacturing and device development at the Cambridge centre, reducing dependency on third-party manufacturers.
-
04
Sustainability and ESG Leadership
Achieve Net Zero by 2050, PEC/PNEC ratio below 1 for all manufacturing sites by 2030, zero waste to landfill, and BSI AMR certification for antibiotics production — with executive compensation tied to ESG goals.
Challenges we see
- Digital Integration
Exiting Novartis TSA dependency while maintaining manufacturing continuity
Following the October 2023 spin-off, Sandoz operates under Transitional Service Agreements with Novartis for critical IT and OT support. The TSA arrangement costs hundreds of millions of dollars annually and creates business continuity risk as the company must manage its manufacturing network while simultaneously building standalone capability.
Where TSA exit timelines are not matched by infrastructure build-out, the company pays twice — both the TSA cost and the transformation investment. Parallel infrastructure build with containerised high-availability architecture means the independence date and the TSA exit date can coincide.
- Operations Manufacturing
Extracting real-time visibility from legacy equipment across multiple sites
High-volume sites in Poland — including Stryków at 5 billion tablets per year and Warsaw running 21 product types across 12 lines — rely on legacy equipment that lacks modern data connectivity. Production information sits in local SCADA screens or Excel files rather than flowing to a central visibility layer.
Where equipment data is local to each machine, the first signal of a capacity constraint or quality deviation is an operator's observation, not a dashboard alert. Retrofit connectivity with real-time OEE monitoring means capacity constraints are visible before they become production shortfalls.
- Operations Operations
Building operator trust in automated systems as skills requirements evolve
The rapid transition from Novartis ownership to standalone operations, combined with new automation deployments, has created workforce uncertainty. Operators accustomed to legacy SCADA systems experience 'Black Box Anxiety' and sometimes revert to manual mode, undermining automation ROI.
Where operator UX replicates the mental model of the physical process — a visual P&ID rather than a database screen — the transition from manual to automated is a matter of familiar design, not new skills. The system earns trust by looking like what the operator already knows.
- Digital Integration
Protecting OT systems as the network becomes independent from Novartis
During the Novartis era, Sandoz's OT systems were protected by centralised enterprise security. As Sandoz builds independent network infrastructure, the integration of factory machines with ERP and cloud systems creates new attack surfaces that were previously managed at group level.
Where OT networks were protected by perimeter security at group level, an independent OT network needs its own zero-trust architecture from day one. Retrofitting security onto an already-connected network is harder and riskier than building it in from the start.
- ESG Regulatory
Meeting PEC/PNEC environmental targets as production volume increases
Sandoz has committed to PEC/PNEC ratio below 1 for all sites by 2030 and links executive compensation to ESG goals. Continuous wastewater API level monitoring is required, but manual sampling and fragmented data collection cannot produce the evidence quality or frequency that regulators and investors expect.
Where wastewater monitoring depends on manual sampling at discrete intervals, the window for detecting a exceedance is the interval between samples — potentially days. Continuous IoT-based monitoring means an exceedance is detected within minutes of occurring, not at the next scheduled sample.
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.
-
Independent high-availability IT/OT infrastructure as TSA exit accelerates
Sandoz is paying hundreds of millions of dollars annually in TSA costs while remaining dependent on Novartis IT and OT support. Prolonged TSA dependency limits operational agility and creates business continuity risk during the critical post-spin-off period.
Build standalone, containerised high-availability manufacturing network infrastructure using Incus clusters and modern orchestration, enabling true operational independence from Novartis on a timeline that aligns with TSA exit commitments.
- Sandoz Risk Management Report, 2024
- Sandoz Capital Markets Day Presentation, 2024
-
Legacy equipment OEE connectivity across Stryków and Warsaw sites
Legacy equipment at high-volume Polish sites lacks modern connectivity, trapping production data in local SCADA screens and Excel files. This prevents real-time OEE monitoring and obscures capacity constraints before they become production shortfalls.
Retrofit industrial data acquisition systems on legacy tablet presses and packaging lines, providing real-time OEE dashboards and potentially extracting 5-10% additional capacity from existing assets as production from closed sites is absorbed.
- Sandoz Capital Markets Day Presentation, 2024
-
Operator UX modernisation to reduce cognitive load and build automation trust
Legacy SCADA interfaces are cluttered and unintuitive, causing alert fatigue and cognitive overload for operators who must reconcile data from multiple systems. 'Black Box Anxiety' leads to manual override behaviour that undermines automation investments.
Deploy UX-first dashboard redesigns that visually replicate physical P&IDs, reducing operator cognitive load and building trust in automated systems to achieve sustainable 'Lights Out' operation in appropriate contexts.
- Sandoz workforce transformation analysis, 2024
-
Industrial cybersecurity zero-trust architecture for the independent OT network
Sandoz's OT systems were previously protected by Novartis's centralised enterprise security. As the company builds independent infrastructure, OT/IT convergence creates new attack surfaces without the protection of the former parent company's security architecture.
Implement a Zero Trust Industrial Cybersecurity Framework across all manufacturing sites, building OT security architecture from the ground up as the independent network is constructed — rather than retrofitting it after connection.
- Sandoz Risk Management Report, 2024
-
Automated ESG monitoring platform for wastewater and environmental compliance
Sandoz has committed to PEC/PNEC ratio below 1 for all sites by 2030 with executive compensation tied to ESG goals. Manual wastewater sampling and fragmented data collection cannot produce the evidence quality or frequency that regulators and investors require.
Deploy continuous IoT-based wastewater monitoring at all manufacturing sites, automatically ingesting API concentration data into an ESG platform that produces regulatory reports and investor-grade sustainability metrics without manual data assembly.
- Sandoz ESG Commitment Documentation, 2024
What we'd propose
- Digital CDMO
Independent high-availability infrastructure for TSA exit
We design and deploy a standalone, containerised high-availability manufacturing network for Sandoz using Incus-based cluster architecture and modern orchestration tooling, enabling true operational independence from Novartis IT infrastructure on a timeline aligned with TSA exit commitments.
-
Containerised application platform
Deploy containerised application workloads across geographically distributed clusters, enabling workloads to fail over between sites without manual intervention and reducing the blast radius of any single site disruption.
-
Network architecture design and migration
Design independent network architecture for all manufacturing sites, executing a staged migration from Novartis TSA infrastructure that maintains operational continuity throughout the transition period.
-
TSA exit governance framework
Establish a TSA exit governance framework that maps dependencies between Novartis systems and Sandoz operations, identifying critical path items and establishing fallback procedures for each major migration milestone.
- TSA costs stop when the infrastructure is production-ready, not on an arbitrary calendar date.
- Business continuity maintained throughout migration through staged cutover with rollback capability.
- Containerised architecture reduces future infrastructure costs compared to the Novartis TSA arrangement.
-
- Digital CDMO
Legacy equipment OEE connectivity and real-time visibility platform
We retrofit industrial data acquisition systems on legacy tablet presses, coating machines and packaging lines at the Stryków and Warsaw sites, ingesting real-time equipment data into a central OEE platform that provides production managers with a live view of availability, performance and quality across all lines.
-
Industrial edge data acquisition
Install industrial edge devices on legacy equipment that capture PLC signals, cycle counts, reject rates and quality parameters without disrupting existing control systems or requiring equipment downtime.
-
Real-time OEE dashboard
Build a real-time OEE dashboard aggregating data from all connected equipment, giving production managers live availability, performance and quality metrics across the Stryków and Warsaw sites with configurable alert thresholds.
-
Predictive maintenance layer
Layer predictive analytics on top of the OEE data to identify equipment degradation patterns — rising reject rates, increasing cycle time variance — before they cause unplanned downtime.
- 5-10% additional capacity extracted from existing assets through real-time constraint identification.
- Unplanned downtime reduced as predictive models surface degradation before it becomes a failure.
- Production absorption from closed sites managed through existing equipment with better utilisation visibility.
-
- Digital Lab
Operator interface redesign for trust and sustained automation adoption
We redesign the operator interface layer across SCADA and HMI systems using a UX-first methodology that maps directly to the physical process — P&ID visual language, intuitive alarm management, and role-based views that reduce cognitive load and build sustained trust in automated systems.
-
UX audit and design system
Conduct contextual UX research with operators at the Stryków and Warsaw sites to understand current pain points, then develop a unified design system that replicates physical process mental models in the digital interface.
-
SCADA/HMI modernisation
Modernise SCADA and HMI interfaces using the new design system without replacing the underlying control infrastructure, minimising validation burden while delivering a step-change in operator experience.
-
Alert management framework
Implement an alarm rationalisation framework that reduces alert fatigue by filtering, prioritising and contextualising alerts so operators see only what requires their judgement, not a flood of system notifications.
- Operator trust in automation systems increases when the interface reflects how the physical process actually works.
- Manual override incidents reduced as operators feel confident that automated systems are showing them the right information.
- Lights Out operation achievable in appropriate contexts as operator confidence in automation builds.
-
- Digital CDMO
Zero-trust cybersecurity architecture for independent OT network
We implement a comprehensive Zero Trust Industrial Cybersecurity Framework across Sandoz's manufacturing network as it separates from Novartis infrastructure — covering network segmentation, device identity management, continuous monitoring, and incident response procedures designed specifically for OT environments.
-
OT network segmentation and architecture
Design and implement a zero-trust network architecture for all manufacturing sites, with strict network segmentation between IT and OT zones, identity management for every networked device, and micro-segmentation within the OT network itself.
-
OT security monitoring centre
Establish an OT security monitoring capability with centralised visibility into security events across all sites, using OT-specific monitoring tools that understand industrial protocols and operational technology risk profiles.
-
Incident response procedures for OT
Develop OT-specific incident response procedures that account for the unique constraints of manufacturing environments — where shutting down a system for investigation has its own operational consequences.
- OT attack surface reduced to a defined, monitored perimeter rather than an implicit trust zone.
- Independent security operations possible from day one of TSA exit, without relying on Novartis infrastructure.
- Regulatory compliance with cybersecurity requirements for pharmaceutical manufacturing demonstrated through architecture documentation.
-
- Enterprise AI
Automated ESG monitoring platform for environmental compliance at scale
We deploy continuous IoT-based wastewater monitoring systems at Sandoz manufacturing sites, automatically ingesting API concentration data into an ESG platform that produces PEC/PNEC ratio calculations, regulatory reports and investor-grade sustainability metrics without manual data assembly.
-
Continuous wastewater monitoring network
Install IoT sensors in wastewater streams at all manufacturing sites to continuously measure API concentrations, replacing manual sampling with automated, contemporaneous data capture that detects exceedances within minutes.
-
ESG data aggregation platform
Build an ESG data platform that aggregates water, energy and waste data from all sites, automatically calculating PEC/PNEC ratios, Scope 1 and 2 emissions, and waste diversion rates against 2030 targets.
-
Regulatory and investor reporting automation
Configure automated reporting modules that produce regulatory submissions and investor ESG disclosures directly from the platform data, eliminating the manual data assembly that introduces errors and delays into quarterly reporting cycles.
- Environmental exceedances detected within minutes rather than at the next scheduled sampling interval.
- Quarterly ESG reporting produced automatically from live sensor data, reducing manual effort and error rates.
- Evidence quality sufficient to support investor ESG ratings and regulatory submissions without retrospective data compilation.
-
Digital maturity: today and target
Scored out of 100 across six dimensions. The target is what Sandoz AG's own published ambition implies — not a perfect score.
- IT infrastructure independence 25 → 85
- Post-spin-off TSA dependency means IT infrastructure is still heavily dependent on Novartis systems. Independent architecture is in early planning and build-out stages.
- Manufacturing data connectivity 30 → 80
- Legacy equipment at Stryków and Warsaw sites lacks modern data connectivity. OEE visibility is partial or absent at most lines, with data held locally in SCADA screens or spreadsheets.
- Operator interface modernity 35 → 75
- Legacy SCADA and HMI systems designed during the Novartis era remain in place. UX redesign and operator enablement programmes are in early scoping.
- OT cybersecurity posture 30 → 85
- OT security was managed as part of Novartis group security. Independent OT security architecture is being built as the network separates from Novartis infrastructure.
- ESG data automation 25 → 80
- Environmental monitoring depends on manual sampling at multiple sites. Automated IoT monitoring is not yet deployed; ESG reporting requires significant manual data assembly.
- Digital capability and change 40 → 75
- Post-spin-off workforce uncertainty and 'Black Box Anxiety' among operators indicate that digital skills development and change management are still in early stages despite automation investment.
Check this yourself
Our Service Portal has free self-assessments and market comparisons. These are the ones that line up with what we've read above — no sales call required.
-
Self-assessment
Electronic Batch Record (eBR) Readiness
Check how far your batch records are from paperless, and what the next step is.
-
Self-assessment
Find Your LIMS
Answer a few questions about your lab and get a shortlist of LIMS that fit it.
-
Market comparison
European CDMOs Compared
The 2026 landscape: who does what, at what scale.
-
Market comparison
Digital Lab: Equipment & Integration Map
Which lab instruments connect to which systems, and where the gaps usually are.
Think we've read this right?
Talk to usRelated reading
-
Cybersecurity for industrial automation and control systems in Life Sciences
Pharma specific hardware and software development is far more complex than only Cybersecurity, but securely designed Product may address...
-
Zero Trust Security Principles
The drive to find new resources for innovation and process improvement in life science companies is becoming more based on technologies.
-
OPC UA protocol support in embedded systems
OPC Unified Architecture (OPC UA) is a modern standard for data exchange, increasingly used in industrial environments.
-
Digital Twin Maturity Model – self-assessment tool
Initially, defining what a digital twin even is seemed simple - we have a real product and its virtual counterpart, and we combine the two.
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 Sandoz 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].