Navigating the Execution Phase of a Commercial Biotech Project

Bringing a new biomanufacturing facility online is both an exciting and critical phase for any company in the industry. At Liberation Labs, we know firsthand that this stage—where concepts become reality—can make or break a venture. It’s not just about breaking ground; it’s about navigating the complexities of engineering, construction, and financial risk to ensure a smooth transition from vision to viable commercial operation. Every decision made in this stage—from selecting the right partners to choosing the optimal project delivery model—has lasting implications for efficiency, cost, and long-term success.

The Tightrope of Commercialization

A useful analogy for biotech commercialization is the famous re-entry scene in Apollo 13: too shallow an angle, and the spacecraft bounces off the atmosphere; too steep, and it burns up. Similarly, companies must strike the right balance—moving too fast can lead to costly operational inefficiencies, while excessive caution can result in running out of funds before operations even begin. Success hinges on strategic execution, balancing risk, and making smart, timely decisions.

Many companies underestimate the degree of integration required across engineering, procurement, and construction to ensure a smooth transition into operations. Delays in one area can cause cascading issues in others, leading to increased costs and prolonged startup times. This is why it’s essential to build flexibility into project plans while maintaining clear accountability and risk management at each phase.

Understanding Project Execution

Once funding is secured, project execution begins, covering the period from detailed engineering to construction completion. This phase is about translating early engineering work into a fully operational facility. The choices made at this stage—including selecting the right engineering and construction partners—determine the project’s ultimate success.

The execution phase typically involves:

• Detailed Design: Translating engineering concepts into actionable blueprints covering civil, structural, mechanical, electrical, and control systems. This stage ensures that every aspect of the facility aligns with process requirements and regulatory standards.
• Procurement: Managing equipment purchases, vendor contracts, and ensuring long lead-time items arrive on schedule. Efficient procurement planning minimizes supply chain disruptions and unexpected delays.
• Construction: Clearing the site, laying foundations, installing utilities, and assembling the facility itself. Effective site management and scheduling are crucial to preventing bottlenecks and keeping costs under control.
• Mechanical Completion: The point at which construction ends, and the facility is ready for commissioning and startup. At this stage, rigorous quality assurance measures must be in place to ensure all systems are properly installed and tested.

Contract Structures: Choosing the Right Model

How a company engages contractors depends on factors like financing structure and speed to market. Here’s a look at common contractual approaches:

Each approach comes with trade-offs. At Liberation Labs, we take a strategic approach—leveraging our expertise in scaling novel bioprocesses while ensuring flexibility where it matters. Choosing the right contract structure is not just about cost; it’s about aligning incentives, managing risk exposure, and ensuring that project objectives are met on time and within budget.

Managing Costs Throughout Execution

Project costs ramp up differently over time. A rough breakdown for a commercial-scale biotech facility:

• Project Development (FEED/FEL3): ~2-3% of total capital cost. This stage ensures feasibility and provides the foundation for accurate cost estimation and scheduling.
• Detailed Design: ~6-8%. The more detailed this stage, the fewer surprises emerge during construction.
• Procurement (Equipment Purchase): ~30%. Equipment purchases should be strategically timed to align with construction milestones and mitigate risks of delays.
• Execution (Construction): ~60%. The largest and most variable cost component, requiring close management to avoid overruns.

Many companies underestimate the impact of early-stage design choices on long-term operational costs. We integrate process engineering expertise early in the design phase to optimize facility performance and reduce costly redesigns.

Looking Ahead

We are laser-focused on the successful execution of first-of-a-kind biotech manufacturing projects. We navigate the critical path between innovation and commercialization, ensuring that our facilities are built efficiently, cost-effectively, and with long-term operational success in mind. By leveraging cutting-edge project management methodologies and industry best practices, we mitigate risks, drive efficiency, and set new benchmarks for biomanufacturing execution.

As we continue to scale up biomanufacturing capacity, the industry must also evolve in its approach to project execution. Standardization, modularization, and digital integration are becoming critical levers for improving speed to market while maintaining cost discipline.

What challenges have you encountered in scaling biomanufacturing facilities? Share your thoughts in the comments or reach out—we’d love to continue the conversation.

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