A Decisive Trajectory: Achieving an Efficient, Sustainable, and Profitable Facility

Involving the scientists and researchers who will use the lab in its design and engineering process is vital for the facility's long-term effectiveness.

Successful commercial endeavors ultimately hinge on financial realities. But in a venture as intricate and critical as building a pharmaceutical/biotech manufacturing plant, focusing intensely on the bottom line will not result in the most overall value. Rather, focusing intensely on strategic planning sets project leaders on a decisive trajectory to navigate the many challenges of constructing these types of high-tech facilities today. To maximize investment, it takes a collaborative approach focused on achieving organizational goals aimed at operational outcomes.

The challenges that await

For start-ups embarking on their first venture into the production of medicines, or even those more established companies looking to expand operations, it is important to understand the challenges that await as they transition from clinical trials to manufacturing. The construction industry still feels the effects of the global COVID disruption while also struggling with issues predating the pandemic. Broken or beleaguered supply chains have greatly increased lead times for procuring equipment and materials. The continued shortage of qualified construction workers and tradespersons has also impacted schedules while driving up labor costs.

Other challenges have arisen as a result of technological advancements. Although these improvements have resulted in more efficient ways to manufacture better pharmaceuticals, they also mean that production lines and the equipment required to run them are more customized than ever. Almost every new development that comes from the science side of a company requires a rethinking of production mechanisms and configurations before progressing to facility design and construction.

In an industry as heavily governed as pharma/biotech, new regulations can also seriously impact how drugs and other medical products are produced and packaged. Stakeholders considering older facilities may seek efficiency gains from new equipment and other technologies. Still, they may need to realize the extent of renovation/redevelopment necessary to modify the facility infrastructure to accommodate the new equipment. New facilities can be "future-proofed" to ensure they have the flexibility to adapt in later stages of their lifecycle.

Breaking the mold on project delivery

While all these issues have made it more difficult and time-consuming to bring life-saving or health-improving products to market, successfully overcoming these challenges provides an opportunity to gain a competitive advantage. It begins by selecting project team stakeholders who can navigate the challenges that inevitably await, including a willingness to challenge the conventional methods for designing and constructing manufacturing facilities.

The relationship between owner and builder can be purely transactional. There was a time when that was standard operating procedure. In the Design-Bid-Build model, which is still commonly used today, roles and responsibilities are strictly defined and siloed to produce a facility that fulfills the list of scope items.

However, traditional models are insufficient in today's competitive world, where identifying and leveraging every possible advantage can be the difference between success and failure. Speed to market is essential for first-of-kind brand name products and especially for generic products, with years' market share ownership determined by who is the first to patent. Builder-led design-build can accelerate speed to market by greatly reducing the duration of a facility's design and construction. Ultimately, committing to an intensive and all-inclusive planning exercise and maximizing collaboration throughout every development phase is the key to a successful project. These are the very elements that have made the design-build delivery method increasingly popular across almost all industries. A variation of this method, in which the contractor plays the lead role, is proving especially beneficial today in the pharma and biotech industry.

In a labor market with limited skilled workers, it's essential to form early partnerships with qualified trade specialists who can handle complex systems.

Allowing the contractor to advance your best interests

Throughout the country, countless projects cannot move forward because equipment and materials costs have greatly exceeded the amount budgeted. Oftentimes, this is the result of a long period of time—years, in some cases—between items being specified during the design phase and the actual point of procurement.

The contractor-led design-build model helps avoid this project-threatening situation by moving procurement up in the development process. This ensures that cost estimates are more accurate and properly reflect price fluctuations. The contractor also has a much better understanding of the availability of specific materials and equipment at any given time and can use this knowledge to decisively identify the most viable solutions.

The labor shortage issue is also less of an impediment when a contractor takes the lead early in the process. An experienced and respected construction company will have developed strong relationships with trade partners and suppliers. These relationships will be pivotal for securing a qualified workforce to complete these sophisticated projects within their designated schedule.

When it comes to such complex facilities, delivering a high-quality project is dependent on selecting the right trade partners and subcontractors to join the team. A seasoned contractor can provide the ability to evaluate each prospective partner in relation to the specific work to be performed on a particular project, a skill that will contribute greatly to overall success.

Engaging the right trade partners early helps achieve cost certainty and optimal performance for critical scopes. This approach allows trades to understand the project goals, scope, and complexities and lock in their labor and accountability through partnership; quality and craftsmanship are prioritized over a bid-based decision.

This is particularly true for collaborations on accelerated projects. To successfully navigate the project, the team needs to be able to execute on tight timelines and defined budgets. This delivery method integrates all stakeholders, creating a nimble team that can quickly adjust and move forward. Success is set up from the outset when owner, contractor, and designer perspectives all come to the table together so that all stakeholders can align interests right from the very beginning in the interest of a successful project.

Rallying around a common goal

While selecting the right project team stakeholders is critical to the success of a contractor-led design-build project, what happens immediately after that team is assembled is equally essential. Even though specific tasks will occur at various points along the project schedule, the insights and expertise of everyone involved should be engaged at the project's onset.

One of the biggest threats to a project's budget and schedule is when something unexpected occurs. It might be an unaccounted-for obstruction buried on the building site, a permit that is slow to get approved, or a utility feed that lacks the specified capacity. The list of things that can go wrong is almost endless, but something seldom happens that hasn't occurred in the past. The unexpected can be anticipated and accounted for by bringing everyone together early. The lessons learned from the past and the best practices developed for addressing them can be used to mitigate surprises and keep the project progressing forward.

A second threat to a project schedule, one equally threatening to success, is setting milestones based on unreasonable or unattainable expectations. A realistic and executable schedule is best achieved by identifying the day the facility needs to start producing and then scheduling milestones retroactively from that target. This exercise should involve the entire team to ensure that every task and contingency is well considered. It should conclude with the commitment of everyone involved to put forth their very best effort to achieve the owner's goals and bring the project home on or before the target production launch date.

For owners eager to see shovels put to dirt, taking the time needed for a comprehensive planning period may make them anxious. However, once they understand the value of coming together as partners and collaborating, they will never want to return to Design-Bid-Build.

Using a construction-led design-build approach, where contractors are involved from the start, can significantly reduce project timelines compared to traditional methods, which allows owners to bring products to market faster in this competitive landscape.

Doing more with existing facilities

Although in the past many manufacturing facilities were understandably overbuilt, with much less specific attention given to the most efficient utilization of space, the mistakes of the past may provide opportunities in the future. A company operating from one of these legacy facilities might find that its plans to expand operations do not require a new plant, as presumed.

Before committing to a new build and the high investment it will require, a feasibility study should be done to evaluate the current space. There may be options where a reconfiguration of production lines or a simple build-out of an existing facility will provide enough space to accommodate the increased production capacity and increase efficiency in the building itself and how it operates. This is particularly true if part or all of the production process is automated or the intent is to introduce or modify automation. Facilities may need to be adapted to accommodate changes in both personnel and equipment.

Effective feasibility studies require designers, contractors, and owners to come together around the client's goals and capture input from end users. The team must evaluate the facility's potential uses and ascertain financial viability. For example, installing the latest production equipment may require overhauling the electrical system. Understanding the existing facility's infrastructure and the project's end goals enables the project team to design an optimal solution aligning with business performance objectives.

Getting your product to market

Because the needs and requirements of pharma and biotech facilities are so specific, and because speed to market is crucial to obtaining or maintaining market share and competitive advantage, it is important to choose project team stakeholders with specialized experience in today's market. Those project team stakeholder firms fully committed to serving pharmaceutical companies will seek to partner with designers, engineers, or managers with past experience working on the owner side. This allows the project to benefit from experienced perspectives and insights, facilitating a more seamless collaboration throughout the project lifecycle while reducing the project's time to complete. These stakeholders also have an in-depth understanding of timelines associated with clinical trials and FDA approvals, which is invaluable in developing optimal construction schedules.

Despite the many challenges facing the construction industry today, the prospects of building an efficient, sustainable, and profitable manufacturing facility are quite promising. These outcomes require the right stakeholder team, the right approach, and a commitment to collaboration, but the keys to success are no mystery. By taking to heart proven strategies, owners are on a trajectory to get their products to market.