Meet the 2022 FOYA Project Execution Category Winner: Janssen Biologics
Winners in this category exemplify the application of novel tools and approaches to delivering projects that improved efficiencies, overcame unusual challenges, promoted effectiveness, and organized stakeholders and project team participants in ways that led to successful outcomes such as efficiency, delivery, quality, product yield, consistency, and cost of goods.
Janssen Biologics won the Facility of the Year Award (FOYA) in this category for designing and building the expansion for their Vaccines Facility (VF) and securing regulatory approval for commercial production of the COVID-19 vaccine in record time. Janssen Biologics also won this year’s Facility of the Year Award (FOYA) in the Social Impact Category for the expansion of its VF.
Janssen Biologics provides commercial and clinical manufacturing services in the field of biotherapeutics and vaccines. It is part of the family of companies of Johnson & Johnson (J&J) and is located in Leiden, the Netherlands. This Dutch city also houses Janssen Vaccines and Prevention, where research and development activities on infectious diseases and vaccines take place and which developed the Janssen COVID-19 vaccine. As part of the Leiden campus, Janssen Biologics was in a unique position to contribute to the pressing need for vaccines at the height of the pandemic. They produced the drug substance that helped supply the vaccine to the world from a newly expanded facility.
As COVID-19 spread across the world, Janssen Vaccines and Prevention developed several potential candidate vaccines, which showed tremendous potential during clinical trials. With successful candidates in the pipeline, J&J researched the production capacity within their network and determined that Janssen Biologics could meet production needs if their Vaccines Facility was expanded. The plans available at the time aimed for expanding the facility in five to seven years. However, the current health crisis drove Janssen to develop an enhanced, fast track project execution approach to design and build a new facility in nine months and to secure regulatory approval for the initial commercial batches of the vaccine in twelve months.
Expanding Janssen Biologics’ Vaccines Facility was a big operational challenge. New tools helped the project team to ensure full alignment with business needs and to drive accountability within the teams. Above all, the project required flexibility, resilience, and teamwork from the talented and motivated people of Janssen Biologics. “We worked around the clock to ramp up the production of the COVID-19 vaccines in challenging times, together with many partners”, said Henri van Drunen, General Manager of Janssen Biologics. “As a big site, we have shown that we are agile and innovative as well. Thanks to our driven and expert colleagues we are ready to face the health challenges of today and tomorrow.”
Good collaboration defined this project. Hans Weverling, Program Lead, emphasized that excellent long-term relations with local partners enabled everybody to move fast. “We worked together with trusted teams, from local construction partners to global partners within J&J. This helped us in moving forward quickly and realizing our ambitious planning.” The early contractor engagement during the design activities significantly reduced the number of handovers and transition of information throughout the construction supply chain and led to the feeling of inclusion and a first-time-right approach.
Another strategy that helped J&J to fast-track the project, was to work closely with the city of Leiden from the beginning of the project. “Our ties with local authorities contributed to our success”, Weverling explained. “We always followed rules and regulations, but efficient collaboration enabled us to complete all steps needed in record time.” For instance, city officials agreed to a phased permit authorization approach which allowed J&J to start some of the construction activities in parallel with design development efforts. This strategy allowed for a smooth review and approval process by the municipality of Leiden, leading to a complete building permit without any delays.
On 1 July 2020, the team laid the groundwork for construction, literally, when the first construction pile for the expansion facility was driven into Leiden soil. The official approval of the facility by the European Medicines Agency came one year and one day later, on 2 July 2021.
Ultimately, this project is an inspiring landmark that proves that if stakeholders’ goals are aligned, facilities can be developed on a highly accelerated schedule while complying with regulatory requirements, benefitting the community and the planet, and upholding project and product safety.
FOYA Judges
About Janssen: Janssen Pharmaceuticals is a global biopharmaceutical company that aims to create a future where disease is a thing of the past. As part of the Pharmaceutical Companies of Johnson & Johnson, they focus on areas of medicine where the need is high, the science is compelling, and the opportunity to make a difference is great.
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.
