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.
End-to-end programme management for complex automation and MES programmes — schedule, risk, stakeholder coordination and commissioning close-out.
Specialist DCS, MES, CQV and process safety engineers placed on a contract or permanent basis. Pre-vetted, sector-specific, available across seven European countries.
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
We have configured DCS and MES systems across the full mammalian process train — from seed train automation through capture chromatography, viral inactivation, downstream polishing and UF/TFF to bulk drug substance formulation. Our Process Automation Engineers understand what is happening inside the vessel, not just what the control system needs to do.
Microbial Fermentation
High-pressure, fast-cycle processes where induction automation, DO cascade configuration and foam management demand DCS engineering that goes well beyond generic settings. We configure the full fermentation control sequence — from inoculation through automated induction to harvest — without requiring an operator to make real-time process decisions.
Antibody Drug Conjugates (ADC)
The most containment-critical process in biotech — where closed system integrity, HPAPI handling and multi-step downstream purification (HIC, CEX, AEX) demand a control architecture that enforces the safety case rather than relying on operator decisions. We configure DCS and MES across the conjugation reaction, purification train, microfluidizer integration and lyophilisation where required.
Fill-Finish & Aseptic Processing
Where drug product is made — and where EU GMP Annex 1 has made automation a regulatory requirement. We configure DCS and MES for aseptic filling, lyophilisation cycle control and compounding as an integrated system — DCS controlling the line in real time, MES executing the recipe and building the electronic batch record automatically.
Buffer & Media Preparation
The foundation of every bioprocess. MES manages weigh and dispense — recipe-driven material selection, lot assignment and electronic dispensing records. DCS manages everything that follows — WFI addition, agitation, temperature, pressure and transfer. We configure ILD systems for real-time conductivity feedback control across the full operating flow range, whether diluting buffer concentrates, caustic solutions or process chemicals.
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. We build CIP and SIP sequences as ISA-88 phase logic within the DCS, managed as MES recipes, with automated deviation detection and electronic cycle records. No paper-based cycle logs. No gap between what the DCS executed and what the record shows.
Utilities — Clean & Black
WFI, purified water, clean steam, HVAC and cleanroom pressure cascade on the clean side — chilled water, compressed gases and effluent on the black side. All configured within the DCS framework as GMP-critical systems, with proper alarm philosophy and standardised interfaces to the broader facility control architecture.
Our Work
05Selected Projects
PBR to EBR — PAS-X MES and SAP Integration, Vaccine Conjugate PPQ
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.
Single-Use Buffer Facility — DeltaV & Syncade, 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 Biologics Facility — DeltaV, Syncade & Kneat, 24/7 Through PPQ
Six 20,000L bioreactors, 27,500m² facility. 3,000 recipe objects. 6,500+ Kneat documents. 24/7 on-site through PPQ.
NPI into Existing CDMO Platform — Gap Analysis, Raman PAT & Adaptation
New drug product introduced into live validated platform — gap analysis, Raman in-line PAT integration, dual-product adaptation under change control.
DCS Recipe Optimisation & MES Migration — DeltaV to PharmaSuite
Full DeltaV recipe layer redesign and Syncade to PharmaSuite migration — every qualified parameter preserved, all DCS-MES interfaces specified and tested before engineering batches.