2022 Category Winners for Social Impact: Janssen Biologics

Janssen Biologics, BV

Location: Leiden, The Netherlands
Project: Vaccine Launch Facility (VLF) Expansion

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.

The Johnson and Johnson vaccine was critical to resolving an unmet medical need during the COVID-19 pandemic by providing the world with a single shot COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. To provide the world with single-shot COVID vaccines, the J&J production capacity needed to be increased. The constrained timeline for the construction of the VLF expansion was one of the requisites for J&J to meet its COVID-19 vaccine supply commitment. An integrated and collaborative project execution approach involving various internal and external stakeholders was required to meet these challenging deadlines.

Janssen was granted regulatory approval (Emergency Use Authorization) of the drug substance batch 12 months after the first pile for the new downstream processing facility. The project team invested the equivalent of 300-man years in realizing the facility and rapidly hired and onboarded more than 250 new employees at their Leiden facility.

The construction activities were executed during an increased level of positive COVID

cases in the Netherlands. J&J kept the personal safety of all project team members as its top priority. J&J implemented various safety measures to reduce the risk of contractors being exposed to the COVID virus.

The additional Covid compliance measures implemented include:

• Use of Covid specific PPE.
• Additional supporting facilities for the construction team, such as a shared break room.
• Use of multiple shifts as they were required to reduce the number of contractors on-site or in specific facility areas.
• Thorough cleaning scheme of all construction facilities.

The impacts of the additional Covid restrictions on the construction workforce did not result in any significant stoppages or slowdowns of the work.

This project is an example of a socially responsible response to an urgent public health need and therefore the FOYA Judges deemed them one of the 2022 category winners for Social Impact.

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