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A More Efficient Way to Deliver Critical cGMP Facilities

Collaborative delivery approaches are ideal for complex, fast-paced cGMP construction that fuels groundbreaking treatments and cures.

This article is included in the Great Things: Issue 11 edition of the DPR Newsletter.

workers inside an in-progress cGMP facility
On Theragent’s CDMO facility in Arcadia, CA, a design-build arrangement helped the team navigate sequencing of work and supply chain challenges for more predictable outcomes.
Solutions to help

Build Faster

When a company is in the business of creating life-saving medicines, speed to market is critical. Project delivery solutions that get new facilities online faster while bringing out the best of a high-performing team is vital. In those situations, collaborative delivery is the prescription.

Eliminating the typically siloed environment of traditional design-bid-build approaches, collaborative delivery demands teamwork, communication and partnership that leads to enhanced schedules, lower real costs, and safer work environments, all while delivering innovative solutions. Collaborative delivery is ideal for complex, fast-paced cGMP construction that fuels groundbreaking treatments and cures.

“In the cGMP manufacturing world, constantly staying on the leading edge while making sure we meet our operational needs really leads to some interesting challenges within a project design scope,” said Andy Campbell of United Therapeutics’ (UT) corporate real estate team. “It's a fun challenge to have.”

a man driving a forklift down the aisle between storage shelves in the warehouse

Four Steps to Collaborate for Success:

  1. Identify Qualified Partners
  2. Set Clear Expectations and Priorities
  3. Own Early Decision Making
  4. Trust but Verify
What are Collaborative Project Delivery Methods?

In an April 2024 white paper, FMI noted that owners, engineering firms and construction firms are strategically selecting alternative delivery methods more frequently. While traditional design-bid-build delivery will always exist, it is no longer the default for many capital projects.

Collaborative delivery, which encompasses methods such as design-build, Engineering, Procurement and Construction Management (EPCM), and Integrated Project Delivery (IPD), focuses on the alignment of people, processes and goals by removing silos. When a team is positioned and incentivized to work together, solving problems becomes easier and can lead to efficiencies that expedite the project from concept to turnover.

“The delivery method will drive behaviors and certain outcomes of a project,” said Gary Schoenhouse, chief technical officer at GeneSuites.

aerial view of a building amongst the trees
The sustainability goals for UT's latest cGMP warehouse exceeded any that had ever been attempted on a facility of this type, requiring extensive collaboration to inform real time cost estimating for different green strategies. Photo Credit: Danny Sandler

“Having a collaborative design and construction process ensures we can run full speed. We need a good bench of trusted partners that can react quickly and who understand our mission.”

- Andy Campbell, United Therapeutics 

The Value of Reduced Rework

An integrated project team can help identify challenges before they arise. That’s because expert knowledge from the designer, builder and trades can be used early on to influence the design sequence, identify prefabrication opportunities, and improve procurement processes. The advantage for owners is reduced rework. The trust engendered by a collaborative set up also fosters an environment where creative solutions and innovative thinking can thrive—tailored to project goals—leading to better outcomes, including cost efficiency.

When rework can account for anywhere between 9-20% of total project costs, owners are understandably focused on how to best invest in their projects. A traditional design-bid-build arrangement, or even a Construction Manager at risk (CMAR) method, is familiar and often favored as a means of achieving cost efficiency upfront.

“There is a perception that you get better value with CM or CMAR,” said John Duffy, Principal at Affiliated Engineers, Inc. (AEI). “But when your project is one of a kind, it’s a bit foolish to think that the delivery strategy should follow what’s always been done. You do need a different approach.”

Duffy points to UT's design-build cGMP warehouse in Research Triangle Park, NC. The sustainability goals exceeded any that had ever been attempted on a cGMP facility of this type, encompassing not only a site net zero energy goal but also zero embodied carbon and LEED® Gold and ENERGYSTAR® certifications.

“When we started to put in passive strategies to reduce energy consumption, it was very helpful to have [the contractor] involved with real time cost estimating,” said Duffy. “The collaborative approach helped us figure out where to spend the money by determining the benefits and tradeoffs.”

As the builder working with Hanbury Associates and AEI, DPR Construction helped qualify suppliers and led discussions with different manufacturers. This enabled the team to integrate both prefabricated assemblies and the exact equipment into the design in a more complete package that did not require later revisions.

Interior of a lab
Optimizing Project Delivery for cGMP Facilities

For owners in the life science space, whether they’re building a biotech research & development or pharmaceutical manufacturing facility, getting science from bench to product is paramount. To build fast requires early decision making enabled by collaboration. In his 25+ years of experience working with some of the biggest companies in the industry, Schoenhouse says he’s seen more cGMP projects moving to establish target value upfront.

“I think owners are seeing the benefit of bringing in their design, construction and subcontractor teams to do more design-assist, especially on fast-track projects,” said Schoenhouse. “In order to really achieve those schedules, you need to bring those teams on early.”

cGMP facilities pose unique challenges. Beyond the potential for evolving project requirements, from a technical perspective there are many complex systems. Aligned teams are more agile in the face of challenges, ranging from eliminating or reducing downtime on existing buildings to managing and incorporating rapidly changing technology.

On the Theragent CDMO Facility project in Arcadia, CA, the team’s mantra of “patients are waiting” was a stark reminder of the high stakes in meeting a tight construction schedule. The design-build delivery method was critical to overcoming permitting challenges, ensuring procurement of raw material on time, and coordinating multiple construction subcontractors. The team successfully completed design, permitting and construction in 18 months in conjunction with trade partners across the country.

Another cGMP facility in Carlsbad, CA, emerged out of the global public need for COVID-19 vaccines, so speed was paramount. The project was completed for Thermo Fisher Scientific in just nine months—including design, permitting and construction—using a design-build contract.

“Having a collaborative design and construction process ensures we can run full speed,” said Campbell, speaking of UT’s approach to their building projects. “Speed to market is incredibly critical because the science is always going to change at some point. No two projects are alike, and we need a good bench of trusted partners that can react quickly and who understand our mission.” The UT facility was delivered on budget 30 months after kicking off design and construction.

manufacturing equipment
Four Steps to

Set Up Collaboration for Success

While very applicable to cGMP and other life sciences projects, collaborative delivery is suited for any project on the leading edge with an accelerated schedule and high quality standards.

four workers gather around an ipad
1. Identify Qualified Partners

All projects rely on teamwork, but team chemistry is critical to successful collaborative delivery. Beyond identifying partners who can perform the work, owners should also look for how their potential partners set themselves up to work together.

DPR’s design management framework, for example, provides dedicated in-house expertise—a “master facilitator”—on fast-track complex projects. In this setup, a DPR design manager works alongside the design team to help streamline integration with trade partners and the preconstruction team. These managers focus on milestone alignment planning, and ensure input from procurement, estimating and constructability during the design process. The goal is to eliminate rework.

“An analogy I like to use is, an electrical engineer cannot do their work without a mechanical engineer, and an architect cannot do their work without a structural engineer,” said Shannon Chase, a DPR design integration manager with nearly 25 years of experience working in the cGMP space. “A design team needs feedback from the construction team. Bringing those aspects together creates a more seamless project that has a higher chance of meeting schedule and budget needs.”

Far from overstepping the design professional’s expertise, it bolsters the design process. “In my role, I can speak the language of the design team and be that interpreter between the design and construction teams,” said Chase.

man points to whiteboard while group looks on
2. Set Clear Expectations and Priorities

Identifying project expectations—from team behaviors to key technical requirements—is essential to making decisions easier and faster. Setting these expectations upfront aligns the team around common goals, project priorities and execution approach. It also ensures that communication and decision making are viewed through the lens of established project goals.

For many large pharmaceutical companies, expectations may also need to be aligned with the owner's project roadmap and engineering standards, developed over decades of project execution. Even with schedule pressures, Chase notes that alignment gained using the roadmap demonstrates even large-scale programs can succeed with a collaborative approach.

“With a fast-track project, it does take a lot of deliberate management and tracking to make sure that multiple workstreams and different phases of design and execution are progressing,” said Chase. “Or if there are deviations, they're being communicated and aligned within a mark that it is acceptable. The roadmap is intended to encompass lots of different types of projects, and you need to agree on which aspects of the roadmap apply.”

It’s critical to set up the integrated team culture from the beginning. But how is a culture established? Chase says it helps to have specific, tangible execution elements that foster communication and openness: a milestone alignment plan, roles and responsibility matrix, clear meeting structure and cluster group organization, a process for decision making and escalation, and communication tools that are easy to use for multiple partners.

Most importantly, the team needs to talk. “Documentation, like action planning logs, dashboards and work plans are the expectation,” said Chase. “You can’t just write things down and post documents.”

a group of people in a meeting setting looking out at a bim screen
3. Own Early Decision-Making

Decisions in the design and procurement process can have long-lasting effects on the project schedule and building operations. Teams map out decision-making and establish milestones at the beginning of the project. Once those milestone decisions are set, they become constraints. All members of the team, including the owner, need to understand and consider who the real stakeholders are when considering the impacts of potential changes.

“It’s hard for owners to do this, especially in the context of going fast,” said Schoenhouse. “What decisions need to be made, and when is the last responsible moment for doing this? It’s ok for things to be fluid up to a point, but it eventually needs to be fixed. It’s up to owners to set decision points along the way.”

For this reason, Schoenhouse emphasizes the importance of setting boundaries around what changes can be made, and by whom. Moreover, everyone—including the designer and builder—needs to be willing to say ‘no’ once a constraining decision has been made.

Schoenhouse points out that failure to have a system in place for managing potential changes can have adverse consequences, and potentially result in delayed completion. He points to one project where the owner’s maintenance team did not like the placement of something. Even though construction was by that time 20% complete, the team made changes that impacted the structural system. The design had to be reworked. Additional steel had to be procured. The costs to both budget and schedule were significant.

Two workers smile looking at ipad
4. Trust but Verify

Trust starts with the owner. Savvy owners verify the team’s qualifications and experience, while trusting them to do what is best for their project. When owners can balance being able to rely on their team’s expertise—and also get involved—creativity and innovation follow.

“Part of what makes a great collaborative project is understanding that everyone has their own area of expertise,” said Campbell. “What we look for in a partnership is someone that’s going to be there with us, who will raise their hand the second something pops up, and work through it together.” For Campbell, being “an intelligent owner” means being part of the solution with their partners to foster teamwork and constant communication. It also means doing the due diligence necessary to vet team members, including those brought in by the general contractor.

“There’s some risk involved anytime you bring in a new partner, especially for critical trades, you're really putting your project success in their hands,” he said. “There's a real benefit, even for new trades, to perform.”

More than anything else, it’s the trust forged by collaboration that can help manage and mitigate against risk. “There’s a lot of risk in a cGMP project,” said Campbell. “Especially when it comes to the schedule and startup systems. And if you’ve got the right people on board early, you can account for those things.”

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