Single-Use Facility Concept for Viral Antigen Production (Cell Culture)

About the Project

The project involved data collection from various sources, followed by cleaning and analysis to identify trends and patterns. We developed interactive dashboards that allowed stakeholders to visualize data in real-time. The insights gained led to improved inventory turnover and targeted marketing strategies, resulting in a 20% increase in sales over the following quarter.

Single-Use Facility Concept for Viral Antigen Production (Cell Culture)

FMD antigen single-use facility — concept to URS

Single-Use Facility Concept for Viral Antigen Production (Cell Culture)

Single-use 1000L, cell culture line

What We Did

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Aligned the concept with commissioning logic (FAT/SAT expectations)

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Reviewed draft design and defined material/personnel flows

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Built a risk-based segregation strategy to reduce cross-contamination and mix-ups

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Drafted a URS framework for single-use bioreactors and key downstream equipment

Deliverables

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Draft Design Audit report + risk register

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FAT/SAT outline and acceptance criteria

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Flow diagrams (materials, personnel, waste)

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URS packages (bioreactors, harvest, inactivation, filtration, buffers/media)

Outcome

Vendor-ready documentation, clearer CAPEX pathway, reduced rework, accelerated technical decision-making.

Ready to Strengthen Your Compliance?

Whether you're preparing for an audit, managing a CAPA response, or building risk assessment frameworks — we deliver practical, GMP-ready solutions.