FOYA Winners Share Lessons Learned in Facilities Development
What do recipients of ISPE’s prestigious Facilities of the Year Award (FOYA) know that has helped their projects succeed? What are the lessons learned from achievements in facilities development, including forward-looking projects that encompass and inspire changes in the industry? Pharmaceutical Engineering® spoke with nine FOYA winners from recent years about the lessons they learned and their advice for those challenged with building a new facility or renovating an existing one.
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.”
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.”
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.”
FOYA Projects Featured in this Article
FOYA AWARD: Project Execution 2020
Location: Tyrellstown, Dublin, Ireland
Total Facility Size: 500,000 square feet
Mission: To transform an existing Bristol Myers Squibb Active Pharmaceutical Ingredient site into a state-of-the-art Biologics Drug Substance Manufacturing Campus that includes consideration for future commercial projects.
FOYA Judges said: “The project demonstrated an exemplary, positive collaboration between all project stakeholders and team members. The project was extremely fast-tracked, with mechanical completion achieved for the manufacturing building within 26 months of start of detailed design, which coincided with the start of construction on site. The project was completed safely, on time, on budget, delivered a successful Process Performance Qualification campaign, achieved LEED Silver rating, and is well on the way to delivering product to patients. The facility now serves as a much sought-after employer in the area and provides a comfortable, aesthetic work environment for employees.”
FOYA AWARD: Social Impact 2021
Location: Saraburi Province, Thailand
Total Facility Size: 119,469 square feet
Mission: Providing equal access to vaccines for all Thai citizens in a zero-waste facility.
FOYA Judges said: “Increased patient access, such as the kind GPO offers, prevents drug shortages by manufacturing critical medications for patients at home and helps mitigate the consequences of rapidly developing public health crises through rapidly deployed vaccines. GPO’s sustainability in its facility design has reduced the environmental impact of GPO on Thailand and, ultimately, the world.”
FOYA AWARD: Operational Agility:
COVID-19 Impact 2021
Location: Grand Rapids, Michigan, US
Total Facility Size: 61,500 square feet
Mission: To develop a state-of-the-art, customer-centric facility with plenty of manufacturing flexibility.
FOYA Judges said: “This project was selected for creating a facility that was able to support a pressing need of the day, response to the COVID-19 pandemic. GRAM’s sense of urgency, commitment to creative project execution and collaboration are commendable and the facility design reflects flexibility, speed, and operational agility.”
FOYA AWARD: Project Execution 2021
Location: Ringaskiddy, County Cork, Ireland
Total Facility Size: 200,000 square feet
Mission: To expand the existing biologics manufacturing facility to ensure a sustainable supply.
FOYA Judges said: “Janssen and their partners worked as an integrated team throughout the project to ensure the workers were focused on safety, compliance, and schedule always. The team overcame many issues during the more than three years of execution, including proceeding forward during the COVID-19 pandemic, which happened as they completed construction and started in full commissioning.”
FOYA AWARD: Honorable Mention 2020
Facility Location: Raritan, New Jersey, US
Mission: To construct a facility in rapid fashion where a cell therapy (JNJ-4528) for patients with multiple myeloma can be manufactured for clinical studies and commercial launch, in conjunction with partner Legend Biotech.
FOYA Judges said: “Janssen used an innovative Commissioning, Qualification, and Validation and hybrid parallel construction approach on the project. The project team expertly executed the innovative Johnson & Johnson Specification, Design, and Verification (SD&V) program for manufacturing systems and equipment and designed utility systems with a focus on sustainability.”
FOYA AWARD: Honorable Mention 2021
Project: Commercial Phage Production Facility Upfit
Location: Morrisville, North Carolina, US
Total Facility Size: 12,000 square feet
Mission: To provide a cGMP commercial phage production environment with maximum flexibility to generate, purify, and aseptically fill therapeutic doses of antibacterial phage to fight critical unmet medical needs and diseases.
FOYA Judges said: “The design attributes and operational procedures Locus Biosciences incorporated into their new facility go beyond the Regulatory requirements.”
FOYA AWARD: Facility Integration & Project Execution 2019
Location: Hangzhou, China
Total Facility Size: 341,000 square feet
Mission: To design, construct, qualify, and deliver a $195 million Biotechnology Campus on time and on budget with a blemish-free safety record.
Pfizer won two awards for the same project.
FOYA Judges said: “Overall, Pfizer’s Global Biotechnology Center had a very high degree of integration from the selection and development of the large molecule network manufacturing platform to the design of the Hangzhou facility and to the program that enabled construction completion within 25 months.”
“The Hangzhou Global Biotechnology Center was completed with a perfect safety record; zero lost time injuries, with 2.7 million hours of site activity. The project team trained 3,700 workers on Pfizer’s safety program. Additionally, the project was completed on time and on budget.”
FOYA AWARD: Honorable Mention 2019
Location: Social Circle, Georgia, US
Total Facility Size: 1,100,000 square feet
Mission: To build a manufacturing facility that could meet the current demand for Takeda’s plasma-derived therapies, expand to adapt to increased demands, and support the emotional, physical, and financial well-being of employees while adhering to strict safety standards.
FOYA Judges said: “The project brought together an unprecedented collaborative effort of subject matter experts from around the world to successfully design, develop and construct a state-of-the-art facility that not only meets Takeda’s production goals but positively impacts the wellness of employees and was built with a stellar safety record.”
FOYA AWARD: Social Impact 2020
Location: Silver Spring, Maryland, US
Total Facility Size: 31,486 square feet
Mission: To build a facility that would integrate into the existing United Therapeutics campus and the Silver Spring community, where United Therapeutics could increase the production of Unituxin to provide it to patients with a rare pediatric cancer and to conduct research for numerous other life-threatening illnesses.
FOYA Judges said: “This project faced unique challenges and obstacles to build the facility but never lost focus on why they were doing this work—to provide medicine for an unmet medical need. The project also took the time to consider the impacts to the community both during and after construction, even including external artwork for the facility.”View FOYA Previous Winners