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Meet the 2022 FOYA Social Impact Category Winner: Janssen Biologics

Marcy Sanford
Janssen Pharmaceuticals

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.

2022 Category Winners for Social Impact: Catalent

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. Catalent is the other winner of the Social Impact FOYA for 2022.

Janssen Biologics won the Facility of the Year Award (FOYA) in this category for delivering its single-shot COVID-19 vaccine around the world, thereby contributing to the fight against the pandemic. Janssen Biologics also won this year’s Facility of the Year Award in the Project Execution Category for its Vaccines Facility (VF) expansion.

Janssen Biologics provides clinical and commercial manufacturing services of complex medicines and vaccines. As part of the family of companies of Johnson & Johnson (J&J), Janssen Biologics contributes to improving access and affordability of healthcare and creating healthier communities. Vaccines are a major part of this effort. As the COVID-19 pandemic hit, Janssen Biologics expanded its Vaccines Facility, helping J&J to supply its vaccine to the world.

Access and affordability were incorporated in the design and distribution strategy of the vaccine. J&J committed to making its COVID-19 vaccine available on a not-for-profit basis. The vaccine was designed to be convenient and cost-effective to distribute and administer, as it may be stored at regular refrigerator temperatures. These factors are particularly relevant in developing countries where people have remote access to healthcare centers and where expensive ultra-cold storage facilities and cold chain infrastructure are limited.

To provide the world with the COVID-19 vaccine, J&J needed to increase production capacity. Janssen Biologics’ Vaccines Facility (VF) in Leiden was identified as having the capacity for expansion. The VF expansion was a fast-track project to increase the commercial manufacturing capacity of vaccine drug substance at Janssen Biologics. The two-story, 25,000 square foot expansion was completed nine months after the start of the construction and received regulatory approval for commercial production in only twelve months.

In this period, Janssen Biologics upscaled the downstream process to allow large-scale batch processing and an increased manufacturing cadence. The improvements gave Janssen Biologics a significantly increased downstream capacity. The project team worked in extended shifts, including weekends, to meet the challenging timelines and minimize the impact on existing production. Remarkably, the facility expansion activities were performed while small-scale COVID-19 vaccine downstream batches were produced, without any operational impact. “We had a number of things to accomplish simultaneously,” explained Erik van Veldhoven, Director of the Vaccines Facility. “We were building a new factory, started up small-scale vaccine production, and worked under new COVID conditions. This demanded a lot from the team and the individual, and I am extremely proud of what we have realized together combining technology and the knowledge available in the team.”

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Early contractor engagement and industry best practices resulted in an enormous reduction of the project timelines and an increased execution efficiency. This agile approach improved global patient access to the new vaccine. Henri van Drunen, General Manager of Janssen Biologics, emphasizes that the experience of this fast-track facility expansion will help J&J to quickly respond to similar situations in the future. “By expanding our vaccine manufacturing services, we are now able to produce our vaccines on large-scale and deliver them around the world. We are looking forward to continuing our efforts and making a positive impact on communities, today and tomorrow.”

This project is an example of a socially responsible response to an urgent public health need.

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.