CQV Delivery for a Greenfield Oncology Manufacturing Facility

Executing a Complex Greenfield Build While Managing Vendor & Resource Constraints

An international oncology manufacturer undertook one of the most comprehensive greenfield oncology manufacturing builds in the Mid-Atlantic region.

The program required rapid scaling of validation, calibration, and qualification activities across multiple systems. All while maintaining strict GMP compliance and aggressive delivery timelines.

Internal engineering teams required a trusted partner capable of absorbing execution responsibility. A single source would reduce the vendor management burden and enable leadership to remain focused on strategic priorities.

Full-Spectrum Commissioning, Qualification, & Validation Support

Ellab was initially engaged for validation support and later expanded into a full-service CQV partnership. Over the course of the 24-month program, we deployed a dedicated team of ten full-time consultants who became an embedded extension of the client’s engineering organization.

We supported the project across the full life cycle, from early-stage planning and specification development through system execution and final qualification.

The team delivered:

• Validation plans.
• Specifications, including URS, FS, and DS documents.
• Executed qualification protocols across facility, utility, manufacturing, and laboratory systems.

Comprehensive CQV & Engineering Scope

The new GMP manufacturing site included multiple cleanrooms, HVAC systems, manufacturing equipment, laboratory equipment, warehouses, and cold storage units, all of which required CQV activities.

Key equipment included:

• Depyrogenation tunnels
• Isolators
• Capper/stopper
• Autoclaves
• HVAC systems
• Cleanrooms
• Blast freezers
• CTU (refrigerator, freezer, incubators)
• Walk-in cold rooms
• Warehouse qualification

In addition, we provided calibration services and engineering support to ensure continuity of execution and schedule adherence.

Integrated Execution & Team Augmentation

Ellab consultants worked side by side with client teams in an embedded model that minimized handoffs and improved coordination. This embedded model minimized handoffs, reduced reliance on multiple third-party vendors, and improved coordination across disciplines.

Scalable CQV Delivery with Timeline Discipline & Regulatory Alignment

We successfully delivered the full CQV scope for the greenfield oncology facility – on time and in accordance with regulatory requirements.

The ability to scale from discrete validation services to full system ownership enabled the client to streamline execution, reduce vendor complexity, and accelerate readiness for GMP operations.

Establishing a Long-Term Trusted Partnership

Through consistent performance and deep integration with the client team, we established ourselves as a long-term partner. The Ellab team became a trusted extension of their validation team, enabling leadership to focus on strategic objectives while relying on us for execution excellence across CQV, engineering studies, and equipment calibration.

Planning a Greenfield Build or Major Expansion?

Ellab’s CQV experts are ready to support your next project from conceptual design through facility qualification and process validation. Contact us for a free consultation and learn how our integrated delivery model can reduce risk and accelerate compliant startup.