The FOYA program each year recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery.

Janssen Sciences Ireland, part of Johnson & Johnson, was awarded the 2021 FOYA Project Execution Category Award in April 2021 for its BioCork2 – Large Scale Fed Batch Facility in Ringaskiddy, Ireland. Janssen embarked on expanding its biologics manufacturing facility to ensure a sustainable supply of lifesaving medicines for patients. The BioCork2 Project was initiated to add new drug substance fed batch capacity at 15,000 l scale.

The project had five key goals:

• Commitment to getting everyone involved home safely each day
• Ensuring no disruption to current production
• Compliance with EHS&S and Quality standards
• Ensuring a fully integrated approach with the current manufacturing site
• Delivering within budget and on schedule

The team was ultimately able to deliver on all five goals through partnership, teamwork, out-of-the-box thinking, and remaining focused on the end goal to get medicines to patients, commented ISPE.

With the assistance of Project Management Group (PMG) as designer and John Sisk & Sons as builder, the team constructed a 200,000 square foot facility on time and within budget with a strong safety performance record. Construction of the facility started in October 2017, with PPQ batches commencing in September 2020.

The project had up to 1,200 people working on site at one point with more than 50 different contractors, more than 60+ equipment vendors, and workers from more than 40+ different countries. This large and diverse workforce required a thoughtful and direct approach to safely involving everyone, which resulted in a DART rate of 0.056 with over 3.8 million person-hours worked without an incident.