Biomanufacturing projects need a tailored design strategy that manages new technology scale-up risks and delivers cost-effective solutions. Moving from lab concepts to commercial production adds complexity. Companies must balance technical demands with cost and schedule certainty while reducing risks tied to first-of-a-kind (FOAK) facilities. Black & Veatch helps clients navigate this process with a stage-gated approach that takes projects from concept to construction and start-up.

Our approach combines the proven front-end loading (FEL) framework for de-risking process-heavy projects with the American Institute of Architects’ (AIA) nimble facility design principles. At the FEL-1 stage, we pair conceptual design with master planning to confirm project goals. This early phase applies a tailored design strategy focused on biomanufacturing’s unique requirements and risks. We integrate facility programming with process design, enabling early layout development for existing facilities or greenfield site selection. Supported by techno-economic analysis (TEA), these steps align technical decisions with financial viability, providing a roadmap for stakeholders and investors when change is least costly.

As projects progress to FEL-2 (pre-feasibility) and FEL-3 (feasibility/FEED), design definition deepens and cost estimates tighten — from ±50% at FEL-1 to ±10% at FEL-3, enabling bankable accuracy for financing. A key step at FEL-2 is a risk assessment, including a Project Definition Rating Index (PDRI) workshop that brings the design team and stakeholders together to identify gaps early and plan mitigation. Process design and technology selection follow, integrated with facility programming to create optimized 3D layouts. Site selection, permitting strategies and infrastructure planning are addressed during this stage to avoid delays and ensure compliance.

Lessons from FOAK projects highlight why early planning matters:

• Large-scale bioreactor performance often differs from lab-scale. Proper design margins for agitation, sparging and cooling help mitigate these risks.

• Cleaning systems must be purpose-built for each unit operation and effluent stream.

• Integrating batch and continuous steps may require additional tanks, recirculation lines and wider flow control bands.

• Building requirements and utility demands (electrical, thermal and wastewater) can significantly impact cost and footprint if not addressed early.

Our approach is collaborative and comprehensive. Engineering and construction teams collaborate early to ensure constructability, safety and cost control. Procurement strategies leverage qualified vendors to reduce technical and schedule risks, while safety programs such as Think, Plan, Act embed best practices throughout execution. Whether the project involves greenfield development or transformation of existing assets, Black & Veatch applies global engineering, procurement and construction (EPC) expertise to deliver predictable outcomes and accelerate time to market.

Tailored front-end planning is more than design. It’s a strategic investment in project success. With integrated FEL design of the process technology and the facility master planning, we help biomanufacturers turn breakthrough science into commercially viable reality.