FOYA Winners Share Lessons Learned in Facilities Development

Patience is key when embarking on a new project and the approach to facilities planning is a long one, according to project leads for FOYA-winning projects. “Overseeing any project is a journey and each day is a little, or sometimes, a lot different from the one before,” said Eric Schnake, Global Engineering Capital Projects and Portfolio Lead for Takeda Pharmaceutical Company’s Plasma Operating Unit. “A project is a little life all in itself. It can take two to three years to complete, or longer. It is not a sprint, it is a long-term commitment, it has a life of its own and goes through cycles.”

The first of those cycles starts with planning, and good planning starts with determining the “why” for your project. “The business case for doing the work is likely the most important and common early consideration on all projects. I can’t remember a time in my decades in the pharmaceutical industry when a customer simply said, ‘I want it and I don’t care what it costs or how long it takes,’” said Thomas Piombino, Vice President, Americas, IPS-Integrated Project Services, LLC. “However, I’ve learned that the cost is not always measured in dollars. In the case of the United Therapeutics project, the cost and schedule of the facility construction was a factor, but the real cost was not meeting the therapeutic needs of their pediatric patient community.” (See the Sidebar that presents an overview of the projects discussed in this article; complete profiles of the projects are at ISPE.org/facility-year-awards)

Proper Planning First

Proper planning at the beginning of a project can save major headaches and setbacks later on. Even if the design stage takes longer than originally imagined, it is important to take the time you need to make sure all the details are in place. “Make sure business requirements are aligned with business scope and objectives,” said Schnake. “You may have people pushing you to get started right away but you have to be able to absorb some of the push back on schedule to make sure that when you start, it is going to work. Balancing the cost and schedule impact with future performance is key. The performance of the plant always has to win. At the end of the day, nobody will remember if the project is a little late or a little over budget, but if you can’t meet capacity, they will remember that.”

Bob Myers, Global Engineering Director, Pfizer, agreed. “Define a clear scope and stick to the scope. Focus on safety and make it integral to the project success, and understand and plan for any country-specific project requirements, permits, inspections, and approvals.” As part of the planning for Pfizer’s Biotechnology Campus in Hangzhou, China, local codes and standards were incorporated early in the design to avoid redesign and schedule delays. They also worked with the Hangzhou Economic Development Area to make sure all documents were in order for imports and road-tested various ground transportation routes.

The COVID-19 pandemic has highlighted worldwide supply chain and labor issues. David Mallonee, Associate Director, Project Management Design Division, IPS-Integrated Project Services, offered advice on how to incorporate lessons learned from the pandemic into project planning going forward. “Modularization and off-site fabrication have become commonplace in our industry. The benefits are well known but one that has risen to the top recently is the result of the supply chain and labor shortages we are experiencing right now. Most projects that started just prior to the pandemic did not understand how much impact this would have on their project costs and timelines. We are all learning from these challenges and adapting to them. Integrating supply chain knowledge and logistics management into project execution has become paramount. The right mix of modularization and off-site fabrication is a great way to mitigate these issues.”

Thailand’s Government Pharmaceutical Organization (GPO) learned how changes to design can become a major setback to a project. “There was a significant design review to follow evaluated requirements for BSL-2 plus production facilities. Consequently, an additional budget had to be approved by the Thai government, which took a long time to get due to political instability in Thailand at the time,” said Withoon Danwiboon, Managing Director of GPO.

“The delayed budget approval also affected the contract management. We learned that having the right design from the very beginning was crucial. In addition, it is advisable to work with the FDA early for facility designing steps.”

Location Considerations

Once a plan is in place, determine where to locate the facility. Often, a project’s location is predetermined due to existing facilities, which can be added on to or renovated. When embarking on a greenfield project, a new development on an undeveloped lot, there are many factors to consider. Both Grand River Aseptic Manufacturing (GRAM) and United Therapeutics chose their sites because of proximity to existing facilities.

GPO’s facility was a new build and Danwiboon said access to supplies and infrastructure were key criteria when they were looking at sites. “To produce an egg-based vaccine, vaccine quality egg supply is crucial. There are several local egg suppliers around Saraburi province. Transportation to the nearest airport or seaport and product distribution were also taken into account. One of the main reasons we decided to locate our vaccine plant in Saraburi province was that there are several industrial estates located in the area. In other words, supporting systems, such as electrical power, city water, transportation, communication, and healthcare, were available and accessible. Moreover, because many industrial facilities had been constructed in the neighborhood, Saraburi province had many skilled workers and a large construction workforce, which minimized skilled labor shortages.”

Having existing space that can be renovated may make the location decision easier, but renovation projects have the challenge of trying to make something new fit into an already existing infrastructure. “It is important to have a clear understanding of the capabilities of existing infrastructure—including critical utilities, electrical, chilled water, HVAC, and compressed gases—to ensure there is adequate capacity and identify redundancy gaps in light of business continuity,” said Jeffrey Reinhardt, Director, Advanced Therapies Supply Chain, Janssen.

“Renovating a facility, as we did at Locus Biosciences, requires a careful design and a well thought-out plan to minimize production interruption,” said Paul Garofolo, CEO, Locus Biosciences. “But this melding of old and new also presents an opportunity to address current problems and to extend the longevity of existing infrastructure as well as facilitate the upgrading and change-out of obsolete systems.”

Team Building

After determining the why and where, the next step to a successful project is to identify who will be on the facility team.

“Build the best team you can get and then retain them for the duration,” said Alan Bateman, Make Asset Management Site Lead, Janssen. The project team for Janssen’s BioCork2 project was comprised of people from 40 different countries. Janssen relied on interactive workshops and visits with global partners, and integrated the teams, management techniques, and values throughout project execution to ensure that the transition from concept to fully operational plant was smooth and seamless.

Bristol Myers Squibb’s (BMS) Multi-Product Cell Culture (MPCC) Project was a major success due to their “One Team” project philosophy. “A ‘One Team’ project approach was promoted by BMS from the outset and ensured the project team focused on the end result, and the collective success of the project,” said Noel Heaney, General Manager Cruiserath Site, BMS.

“All team members partnered with a focus on open communication, transparency, collaboration, flexibility, fairness, rapid and local decision making, and safety. The ‘One Team’ approach was a key reason why the project was successfully completed on time, on budget, and to the highest safety standards,” said Anthony Carter, Director, Project Realization, BMS. “A key driver behind the ‘One Team’ philosophy was the assertion that ‘bad news does not get better with age.’ This promoted open communication and transparency and resulted in a collaborative team of individuals from multiple companies working together for a common goal, with the intent of resolving issues as ‘One Team’ together for patients.”

Myers added that once the team is in place, it is important to empower them to make decisions, partner with world-class companies and top local contractors, treat all partners as peers, develop shared goals, and encourage a philosophy of mutual respect for all people.

After determining the why and where, the next step to a successful project is to identify who will be on the facility team.

Challenges are bound to arise with any project. Some, like Pfizer’s need to transport 77 production modules from Europe to Shanghai to Hangzhou safely and on schedule, can be foreseen and planned for ahead of time. Others, like political unrest and global pandemics, are not as easily predictable, but with the right design and the right team, it is easier to determine next steps to overcome challenges and get the project back on track, or sometimes switch tracks.

“Every project, especially one at this scale, comes with challenges,” said John Wichelt, Vice President, Client Pharmaceutical Services, GRAM. “The most unexpected and unpredictable challenge we met was having a pandemic start while we were in the middle of qualifying GRAM’s new equipment. We had contractors from out of the country on site for equipment startup and qualifications, and when the news arrived about COVID-19, they had to leave immediately. Our team stepped up right away, went to virtual sessions with the contractors, and performed all the startup and qualification activities themselves. This was a huge success and allowed the project to stay on schedule, which ultimately resulted in GRAM becoming one of the companies to manufacture a vaccine for COVID-19.”

“The most challenging aspects of this project were timing and safety, in that we were midstream when the pandemic hit,” said Garofolo. “Despite COVID-19 presenting significant challenges across the industry, we were able to successfully complete a world-class modular cGMP viral vector manufacturing facility through continued innovations and dedicated partners. Construction began on 4 November 2019, and was complete 12 August 2020, and there were no COVID-19 cases or impacts on any worker and zero recordables or lost time.”