Meet the 2022 FOYA Social Impact Category Winner: Catalent
Winners in this category exemplify application of novel approaches, standards, and practices which result in efficient processing, resourceful utilities, and business advantage by increasing patient access and preventing drug shortages through in-country-for country manufacturing; outbreak, epidemic, or emerging health crisis response via rapid deployment and fast-track drug production; and designs which overcome specific geographical challenges.
Given the unique challenges surrounding the COVID–19 pandemic, there are two projects the FOYA judges are recognizing in the category of Social Impact. Under normal circumstances, projects of this type are challenging. However, the global public health driver to execute these projects in record time, and deliver commercially approved vaccines, in large volumes, was unprecedented and therefore deserves recognition for Social Impact. Janssen Biologics is the other winner of the Social Impact FOYA for 2022.
In 2017, after moving into a new one-million-square-foot facility in Bloomington, Indiana, Catalent turned their attention to an existing shell space at their site, known as Building C. Their plan was to tear down half of that unused shell space and rebuild it into a state-of-the-art aseptic fill-finish building with vial and syringe filling lines supporting biologic products. The project, dubbed Project Mercury, started in July 2019 with the goal of providing maximum flexibility to respond to industry needs, but like most plans made and started in 2019, Catalent’s pivoted in 2020.
On March 11, 2020, as the Catalent team was installing structural steel at the site, the WHO declared a global pandemic. Shortly after, Catalent was approached by a vaccine candidate producer to secure manufacturing capacity, however, it would require Catalent to complete Project Mercury and be ready to produce by January 2021, a year earlier than previously planned. Catalent immediately added more members to the Project Mercury team and began modifying their plans.
Originally, the plan was to integrate Building C into the rest of the Catalent facility with warehousing, packaging, inspection, and other core functions happening at the main facility next door. But Catalent still faced many unknowns surrounding the kind of vaccine they would be manufacturing, so they made a bold choice to ensure their ability to produce any kind of life-saving therapies or vaccines: they upgraded the building to segregated viral manufacturing.
While this decision would ready Catalent for any type of vaccine and provide future flexibility beyond the pandemic, it meant adding several new and complex requirements:
- Automated visual inspection equipment
- Cartoner
- Palletizer
- QC labs
- Cold chain warehousing
- Dedicated material entrance and exit
- Segregated HVAC
- Modified air pressure cascades
- Additional airlocks
The new equipment alone would normally require a nine-to-twelve-month delivery lead time. With only eight months until opening day, Catalent had to find a supplier with equipment at the ready so they could have the facility re-designed, built, installed, and qualified by the end of the year. The team also had to add dock spaces, lab space, two stability chambers, two levels of cold storage, as well as inspection, packaging, shipping—all squeezed into the same footprint as the original design and requiring sensible incorporation into a completed program. The design team dug in immediately and completely overhauled the original plans.
In addition to these challenges, Catalent faced supply chain issues, potential worker fatigue, and fear of an internal COVID-19 transmission; but by planning thoroughly and being flexible when necessary, Catalent completed a brand new building that has room for continued expansion and offers future capacity for new technologies.
Catalent’s Project Mercury was delivered in the face of the global pandemic. With an unknown manufacturing process for a vaccine candidate under development, the team pivoted on existing projects to ensure success, adding 40% more scope including secondary packaging and inspection. The project added 40,000 square feet to cover the most stringent of the unknown needs of the process, reducing the risk to supply. The project team also cut six months off their schedule. The team beat the clock while managing the complexities of execution within the COVID-19 restricted environment and delivered the needed capacity to meet important pandemic demands.
FOYA, the judges
About Catalent: Catalent is a global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is an industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of nearly 7,000 products to over 1,000 customers annually. Catalent’s expert workforce exceeds 19,000, including more than 2,500 scientists and technicians.
Nominate Your Facility for the 2023 FOYA Program!
Apply for a chance to join this prestigious list of innovative game-changers and let ISPE honor your organization as a 2023 FOYA program winner. Applications must be submitted by 2 December 2022.
