2022 Category Winner Project Execution

Janssen Biologics BV in Leiden, the Netherlands, is a J&J biopharmaceutical production and laboratory testing facility that produces clinical and commercial bulk active pharmaceutical ingredients and provides analytical testing services for J&J’s global portfolio of vaccines. The site also houses J&J’s Vaccine Launch Facility (VLF), an innovative manufacturing facility that supports large-scale production of vaccines for late-stage clinical trials as well as the launch of new vaccines on a large scale for global public use. The existing VLF represented an opportunity to enable large-scale COVID-19 vaccine drug substance manufacturing by building a new, 25,000 square-foot sterile manufacturing facility adjacent to the existing VLF.

A fast-track project was developed to design and build the new facility within 9 months and to secure regulatory approval for initial commercial batches produced in the facility within 12 months. The ambitious timeframe required a Herculean effort and flawless collaboration on the part of all involved parties, including best-in-class design and construction partners and an integrated, cross-functional team within J&J.

In addition to an aggressive timeframe, the project faced other challenging circumstances including completing the project while simultaneously enabling the production of small-scale vaccine batches without any operational impact and ensuring the safety and wellness of the entire project team during the height of the pandemic by observing additional safety protocols to prevent COVID exposure

Work began on the facility in July 2020, and construction was completed in the first quarter of 2021. Regulatory approvals were received within 11 months of the project start date, beating the team’s target by a month. This unprecedented delivery was made possible by early contractor engagement, unique project/program methodologies to enable rapid decision-making, and processes/tools that ensured close end-to-end collaboration/alignment with business stakeholders.

J&J’s “safety-first” culture resulted in 19,200 person-days without a single lost-time incident, no serious safety incidents during 600,000 total person-hours (including 153,000 construction hours), zero lost work-day cases, no serious injuries, and no non-planned impacts on operations.

The project delivered additional benefits to the community in the form of sustainability features, including water efficiency, HVAC energy recovery, LED lighting and associated energy-saving controls, and low-emitting materials in building construction.

The project also led to the hiring of more than 250 full-time employees and up-skilling existing employees to enable increased manufacturing output.

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.

For these reasons, ISPE honors the Janssen Biologics Vaccine Launch Facility Expansion Project with the 2022 ISPE FOYA Project Execution Category Award.

Supply Partners and Key Participants:

Manufacturer/Owner Name: Janssen Biologics B.V. (affiliate of Johnson & Johnson)
Engineer/Architect (A&E): DPS Engineering (Netherlands) B.V. (affiliate of DPS Group)
Construction Manager: John Sisk & Son (Europe) Ltd. (affiliate of John Sisk & Son)
Main/General Contractor:

• Van Lith Bouwbedrijf B.V.
• Kuijpers PHF Services B.V. (affiliate of Kuijpers)

Clean Room Contractor: Cleangrad d.o.o.
Piping Subcontractor: Engie
Electrical Subcontractor: Elektravon Elektrotechniek (part of De Groot Installatiegroeop)
Automation and Control Supplier + Process Equipment Commissioning & Qualification: Agidens Life Sciences B.V.
Automation and Control Suppliers: Honeywell B.V. (part of Honeywell Building Solutions)
Major Equipment Suppliers/Contractors:

• WHP
• Cytiva Europe GmbH
• Merck Millipore Ltd.
• Sartorius Stedim Systems GmbH