Engineering Clarity for Biotech Manufacturing.
We design, integrate and validate the DCS, MES and compliance systems at the heart of GMP-regulated facilities — aligning process, automation and quality from concept to go-live.
Start a projectFrom concept to go-live.
- / 01 Life sciences Pharmaceutical & biotech only
- / 02 European hubs IE · UK · DE · CH · DK · AT · RO
- / 03 Embedded delivery Start-up through go-live
- / 04 GMP-ready EU GMP, ICH & FDA aligned
We go beyond staffing. We build, deploy and deliver.
01Distributed control system design, configuration and optimisation — built around your process, your platforms and your validated requirements. DeltaV, Siemens PCS 7 and Rockwell, delivered to GAMP 5.
Werum PAS-X, Siemens Opcenter, Syncade and PharmaSuite — from recipe design and electronic batch records through to MES-ERP integration and operational readiness.
Commissioning, qualification and validation from IQ through to PQ — including CSV and computer system validation, aligned to GAMP 5 and EU GMP Annex 11.
DCS and MES gap analysis across source and receiving sites — mapping CPPs, CQAs, alarm philosophy and control logic. Paired process and automation engineers, from gap identification through to validated close-out and NPI readiness.
Bridging facility design, manufacturing operations, and automation requirements.
End-to-end programme management for complex automation and MES programmes — schedule, risk, stakeholder coordination and commissioning close-out.
Engineering the safety layer that protects your people, your process, and your licence to operate.
Specialist DCS, MES, CQV and process safety engineers placed on a contract or permanent basis. Pre-vetted, sector-specific, available across seven European countries.
Connecting your manufacturing systems, data and operations — so decisions are based on what’s actually happening on the floor.
AI-assisted engineering tooling for DCS and MES design — built on real project experience, designed for GMP-regulated environments.
Why Rockstone
02A focused partner for the most critical layer of manufacturing.
Where others emphasise scale, we emphasise precision.
Where others sell transformation, we deliver operational readiness.
Where others provide resources, we provide ownership.
Our Approach
03Manufacturing Areas
04From seed train to fill-finish — the manufacturing environments where our Process Automation Engineers configure DCS and MES systems that are standardised, integrated and designed to talk to each other seamlessly.
Mammalian Cell Culture
Our Process Automation Engineers have configured DCS and MES systems across the full mammalian manufacturing train — from seed train automation through capture chromatography, viral inactivation, downstream polishing and UF/TFF through to bulk drug substance formulation. We understand what is happening inside the vessel, not just what the control system needs to do. That understanding is what allows us to find a control gap in the viral inactivation hold sequence or a recipe logic issue in the polishing chromatography before it becomes a validation finding rather than after.
Microbial Fermentation
Microbial fermentation is faster, more aggressive and less forgiving than mammalian cell culture. Growth rates are higher, oxygen demand more volatile, and the induction phase — where the culture switches from growing biomass to producing the target protein — is where most DCS implementations fall short. Standard out-of-the-box DCS configuration cannot define the threshold for induction and respond to it automatically. Our Process Automation Engineers configure the full fermentation control sequence as an integrated DCS and MES system — DO cascade, feed management, foam control and automated induction — running from inoculation to harvest without requiring an operator to make real-time process decisions.
Antibody Drug Conjugates (ADC)
ADC manufacturing is the most technically demanding and fastest-growing process type in biotech. It combines two complete manufacturing pathways — the biological production of the antibody and the chemical synthesis of the cytotoxic payload — and brings them together in a conjugation reaction that requires precise chemical control, containment engineering and a downstream purification train significantly more complex than standard mAb downstream. Our Process Automation Engineers understand the full sequence and configure the DCS and MES integration to match every step — as one connected system, not a series of standalone skid controllers.
Fill-Finish & Aseptic Processing
Fill-finish is where drug substance becomes drug product — and where the revised EU GMP Annex 1 has made automation a regulatory requirement, not just an efficiency preference. Our Process Automation Engineers configure DCS and MES for aseptic filling environments as an integrated system: DCS controlling the filling line, the lyophiliser and the supporting process equipment in real time; MES executing the batch recipe, capturing every in-process result and building the electronic batch record that QA needs to release the batch. The two systems are configured to talk to each other — so that a DCS event triggers the correct MES workflow and the batch record reflects exactly what happened on the line, automatically.
Buffer & Media Preparation
Buffer and media preparation is treated as background infrastructure at most facilities. It is not. When the ILD control logic is wrong, the solution going into the downstream column is wrong. When the MES recipe for a media make does not capture the right raw material lot, the batch genealogy has a gap. We configure DCS and MES for buffer and media preparation as primary process systems — the same level of control engineering, recipe management and data integrity attention as the bioreactor or the filling line.
CIP / SIP Systems
Poorly designed CIP/SIP automation is one of the most consistent sources of GMP deviation we see — and one of the most preventable. The control logic determines whether a cleaning or sterilisation cycle achieves its validated endpoints every time, or whether an operator is compensating for a sequence that does not quite work. Our Process Automation Engineers build CIP/SIP automation so the cycle runs, the endpoints are hit, the record is complete and there is no ambiguity about whether equipment was clean and sterile before the batch started.
Utilities — Clean & Black
Utilities are GMP-critical systems. They are not background infrastructure. When a WFI generation system drifts out of specification, when a cleanroom pressure differential deviates, when a clean steam quality excursion goes undetected — the impact lands directly on the batch, the batch record and the regulatory inspection that follows. Our Process Automation Engineers configure DCS systems for both clean and black utilities with the same rigour as the process equipment — standardised control architecture, proper alarm management and clean integration with the broader facility DCS.
Our Work
05Selected Projects
Paper to Electronic Batch Record — PAS-X MES and SAP Integration for a Pneumococcal Conjugate Vaccine PPQ Campaign
14-valent pneumococcal conjugate vaccine PPQ campaign — paper to electronic batch record transition with PAS-X and SAP integration before the first PPQ batch ran.
Multi-Modality GMP Buffer Facility — DeltaV & Syncade from Process Design to Swissmedic Licence
Multi-customer, multi-modality GMP buffer facility — mammalian, microbial and mRNA vaccine programmes — designed in, automated and licensed from day one.
Large-Scale Mammalian Biologics Facility — Full DeltaV & Syncade Build, Kneat eValidation System and 24/7 CQV Support Through PPQ
Six 20,000L bioreactors, 27,500m² facility. 3,000 recipe objects. 6,500+ Kneat documents. 24/7 on-site through PPQ.
New Product Introduction into Existing CDMO Platform — Automation & MES Gap Analysis, PAT Integration and Adaptation
New drug product introduced into live validated platform — gap analysis, Raman in-line PAT integration, dual-product adaptation under change control.
DCS Recipe Layer Optimisation and MES Migration — DeltaV Redesign and Syncade to PharmaSuite, Large-Scale Mammalian Facility
Full DeltaV recipe layer redesign and Syncade to PharmaSuite migration — every qualified parameter preserved, all DCS-MES interfaces specified and tested before engineering batches.