Case Study
Multi-Modality GMP Buffer Facility — DeltaV & Syncade from Process Design to Swissmedic Licence
The Challenge
One platform. Three modalities. Multiple clients. Full segregation throughout.
A global biopharmaceutical contract manufacturer was establishing a new dedicated GMP buffer manufacturing facility in Switzerland — a multi-customer, buffer-only facility supplying process buffers for mammalian cell culture, microbial fermentation and mRNA vaccine manufacturing programmes running concurrently. One platform. Three modalities. Multiple clients. Full segregation throughout.
The multi-modality, multi-customer scope defined the automation challenge. The DCS and MES had to manage separate recipe sets, separate quality standards and separate batch record structures for mammalian, microbial and mRNA programmes simultaneously — with no cross-contamination of lot genealogy between customer batches and no compromise to any programme’s data integrity.
Within that context, the COVID-19 mRNA vaccine buffer supply was the highest priority — the mRNA manufacturing programme this facility served was operating under an extraordinary global health timeline and the buffer facility’s operational readiness was a hard dependency for that programme.
The facility used single-use technology throughout — changing the automation design fundamentally. Without permanently installed instrumentation in vessels that change every batch, every measurement, every control loop and every transfer sequence had to be designed around a disposable system. In a multi-modality facility, that challenge was compounded across three processes with different CPPs, different buffer compositions and different quality expectations. The facility also required a Swissmedic manufacturing establishment licence before any GMP material could be produced.
The Scope
Rockstone was engaged at the process design stage — before equipment was specified and before the process area layout was fixed. Our Process Automation Engineers contributed to process flow design for the buffer manufacturing areas, specifying instrumentation positions, control loop requirements and MES interface points as part of the facility design from the outset.
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DeltaV DCS — process area control across three modalities
DeltaV was configured for the full buffer preparation process area — single-use mixing system control, WFI addition sequencing with inline conductivity and pH monitoring, and single-use transfer sequencing across the facility. The multi-customer model required DeltaV configuration that segregated each production campaign clearly — separate batch identities, separate alarm management and no shared control sequences across concurrent customer programmes.
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Syncade MES — multi-customer segregation and full traceability
Syncade was configured with separate recipe sets for each modality and each customer programme, weigh and dispense module managing raw material lot assignment independently per programme, and electronic batch records structured to meet each programme’s specific documentation requirements from a single platform. The DeltaV-Syncade interface ensured every controlled addition and transfer was automatically captured in the correct customer batch record in real time.
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Swissmedic licensing support
Testing and qualification support was delivered across the full DeltaV and Syncade process area scope — supporting the facility through the technical testing and documentation required for the Swissmedic establishment licence application and GMP inspection.
The Outcome
- Licensed Swissmedic licence and GMP certificate
- On schedule COVID-19 mRNA vaccine buffer supply met
- Zero cross-contamination across three modalities
The facility was operational within the required timeline. Every buffer make across all three modalities was traceable, auditable and regulatory-submission ready for each customer independently — from a single facility, running concurrently, with no compromise to data integrity or batch record completeness for any programme.