Celebrating Best of the Best in Pharma & Biotech Manufacturing Facilities
The thirteenth annual Facility of the Year Awards (FOYA) banquet opened on Tuesday evening, 6 June, at the Crystal Gateway Marriott in Arlington, Virginia US. After welcoming honorees and attendees from the ISPE/FDA/PQRI Quality Manufacturing Conference, Dave DiProspero, Associate/Director, Pharmaceutical Process Technology, CRB Consulting Engineers, and Chair of ISPE’s Facility of the Year Awards (FOYA) Committee, introduced John Bournas, ISPE CEO and President.
“Tonight,” said Bournas said, “we are here to highlight the best of the best—exemplary projects that epitomize the spirit of FOYA.” The category award winners and honorable mentions hailed from the United States, Puerto Rico, Ireland and Indonesia. The latter, he noted, was being recognized for the country’s first FOYA award. These “eight remarkable facilities,” he added, “represent the diversity of thought that fuels intellectual discourse and debate, and fosters innovation which is the cornerstone of ISPE.
“We are proud to honor these facilities for their shared commitment to innovation—for advancing pharmaceutical technology by demonstrating creativity and excellence in facility design, construction, and operations,” Bournas said. “This group of winners is honored for their diverse projects in a variety of topics important to ISPE, our strategic plan, and to the future of the pharmaceutical industry.”
Mike Arnold, ISPE International Board of Directors Chair and Investigational Product Business Process Owner, Pfizer Global Clinical Supplies, also addressed the gathering, noting FOYA’s significance to ISPE. As he surveyed the poster display of FOYA winners earlier that day, he said, he felt as if he were “standing in the present and looking at the future.” He applauded the winners for being “creators of disruptive innovation.”
Jim Breen, Vice President and Lead, Biologics Expansion, Janssen Pharmaceuticals, and current Chair of the Facility of the Year Award Judging Committee, welcomed incoming Committee Chair and ISPE Board member Tony Crincoli, Executive Director and Head of Global Engineering Services, Bristol-Myers Squibb. Together they presented awards to the 2017 Category Winners and Honorable Mention recipients.
Cook Pharmica won in the Equipment Innovation category for its Flexible Filling Line project in Bloomington, Indiana, US. Meant to pursue Cook’s mission to add flexibility and capacity within an existing cGMP space by leveraging new technologies, this project was a collaborative development between owner, suppliers, and engineering experts. Together, they delivered a novel application of commercially available and custom-developed equipment manufacturing solutions that drove superior market-changing technology and supply chain flexibility in a unique “ready-to-use” vial platform.
As project sponsor and COO Ryan Hawkins accepted the award, he told the audience “Nobody completes projects like this alone.” He thanked his “great partners” and “talented team that made the difference.”
The Facility Integration award went to Bristol-Myers Squibb for its Biologics Development and Clinical Manufacturing Building project in Devens, Massachusetts, US, which was designed to transition BMS into a next-generation biopharmaceutical company. The project is an example of how to integrate new capabilities within an existing plant through careful design, good collaboration, and creative engineering. Modifications to the existing campus, with additions to the utilities, parking, garage, central utility building, pipe rack, and storm-water management, required a deliberate focus on planning and integration. The results were impressive, integrating the facility within the company’s broader mission and network of the assets.
As Morrey Atkinson, PhD, project owner and Vice President, Biologics Development and Clinical Manufacturing accepted the award, he explained that he was doing so in memory of a friend who had died from melanoma. “I’m working to make that a thing of the past,” he said.
Eli Lilly and Company earned two FOYA awards in 2017 for its Continuous Direct Compression Manufacturing Kits 2 and 3 project located in Indianapolis, Indiana, US, and Carolina, Puerto Rico. The first award was in the Facility of the Future category.
With a stated mission to design and implement a network of state-of-the-art continuous manufacturing process facilities, Lilly was recognized in this category for process development, production platform commitment, and deployment of three replicate operational continuous oral solid dosage (OSD) production facilities. Fundamental to the project’s success was the development of the progressive mass balance control scheme, which was anchored by advanced automation and process analytical technology, both key to insuring consistent control, low process variability, and high quality assurance.
Bret Huff, Vice President of Small Molecule Design and Development accepted the award. Noting the team’s refusal to compromise on speed, quality, or costs, he called the project a “win-win-win for everyone, but especially for the patients.”
The winner in the Operational Excellence category went to Abbott Diagnostics for its New Quality Approach project to create a sustainable continuous improvement culture at its Longford, Ireland site. The facility has increased productivity, improved changeover efficiencies, eliminated backorders, and enhanced product quality while also reducing cost per unit, cycle times, equipment downtime, and inventory holdings.
On hand to accept the award was Everett Tucker, executive sponsor for the program and Division Vice President, Operations Strategy and Engineering. He praised the “industry-leading body of work on display” among the honorees’ projects, and thanked his team for their “exceptional job delivering real results.”
Jazz Pharmaceuticals was the Project Execution category winner, for its “Project Rock” project in Athlone, Ireland. The project team—which had never built a pharmaceutical facility before—resolved to create a fully operational FDA-approved manufacturing plant in two years. The company drew on a variety of external sources, ensured that recruits were aligned with the company’s culture and objectives, and delivered a greenfield-licensed facility against very aggressive targets. The approach was highly pragmatic, and a model for lean project execution and integration of the investment from project phase to licensed GMP operations.
Accepting the award, Alan Mac Neice, Executive Director and site leader, said that the team “did something truly remarkable by not recognizing where boundaries were.”
Eli Lilly and Company’s second FOYA for its Continuous Direct Compression Manufacturing Kits was awarded in the Process Innovation category. The company’s forward-thinking approach was recognized for the implementation of continuous direct compression and other process innovations in OSD facilities across its manufacturing network.
Bret Huff also accepted this second award saying, “This is much more than just a facility—it’s all of the systems that go into it.”
Three projects earned Honorable Mentions, beginning with Nephron Pharmaceuticals for its Nephron South Carolina project in West Columbia, South Carolina, US. Nephron CEO and Owner Lou Kennedy had a hand in every aspect of the state-of-the-art facility. Her vision—a completely automated plant that would inspire children to want to learn about technology and science—was recognized for its use and integration of industry-leading technologies such as laser-guided vehicles, automated warehousing, robotics, and track-and-trace technology. Viewing and access areas were designed to facilitate visitor exposure to the pharmaceutical industry, helping to promote and advance pharmaceutical manufacturing careers.
Kennedy accepted the award with obvious delight. “It’s like an Oscar! Thank you so much!” she said.
The second Honorable Mention went to Novartis – UPenn and their Center for Advanced Cellular Therapies project in Philadelphia, Pennsylvania, US. The facility, an innovative center to advance personalized medicine, leverages pharmaceutical engineering principles to merge academic, corporate, and medical considerations. The project advances the development of new operating models to harness the potential of personalized cancer treatments.
Joseph Palombit, MBA, RA, LEED-AP, Senior Project Manager for Real Estate, Design and Construction for the University of Pennsylvania Health System accepted the award, thanking his team for working through the challenges of construction in an occupied facility.
The final Honorable Mention went to PT Kalbio Global Medika for its Biotech Facility project in Jakarta, Indonesia. Kalbio’s young and highly motivated project team exemplifies the can-do spirit and demonstrates the potential for biomanufacturing in the region. A point of pride for the company is its quality management system, designed in accordance with PIC/S standards, which integrates all aspects of manufacturing and supports Kalbio’s ambitions to expand its products to regional and international markets.
Christopher Sweeney, Senior General Manager, praised his “very young, hardworking, and dedicated team.” Noting that biotech is taking off in Asia, he also asked ISPE to “help bring knowledge and skills to the region.”
Join us at the 2017 ISPE Annual Meeting & Expo on 31 October 2017 in San Diego, California, USA, where the Overall Facility of the Year Award Winner will be announced.