ISPE honors the Janssen Biologics Vaccine Launch Facility Expansion Project – in which Agidens was responsible for the process automation and the commissioning qualification & validation – with the 2022 ISPE Facility of the Year Awards Project Execution Category Award.
Janssen Biologics BV in Leiden 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.
Pieter Tilkens, General Manager Life Sciences at Agidens: “Together with our other business units, the Dutch Life Sciences division worked with might and main on this challenging project. This recognition from the ISPE is also a crowning achievement for Agidens.”
Henri van Drunen, General Manager at Janssen Biologics: “I am immensely proud of what we have achieved as a team. Together with many partners, we have worked continuously in challenging times to scale up our vaccine production.”
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.
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.
The ISPE Facility of the Year Awards (FOYA) is an annual program that recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, to reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery.
ISPE’s Facility of the Year program is about much more than just the science and technology of the facilities. More importantly, it’s about recognizing the shared commitment and dedication of individuals working for different companies worldwide to innovate and advance pharmaceutical manufacturing technology for the benefit of all global consumers.