2021 Category Winner for Project Execution & Overall Winner

Janssen Sciences Ireland

Location: Ringaskiddy, Ireland
Project: BioCork2 – Large Scale Fed Batch Facility

Project Execution      overall winner

Janssen Pharmaceuticals is a global biopharmaceutical company with the goal to create a future where disease is a thing of the past. Janssen, part of Johnson & Johnson family of companies, focuses on areas of medicine where the need is high, the science is compelling, and the opportunity to make a difference is great. To support this mission, Janssen embarked on an expansion of its biologics manufacturing facility in Cork, Ireland, to ensure a sustainable supply of lifesaving medicines for our patients.

The BioCork2 Project was initiated to add new drug substance fed batch capacity at 15,000 L scale. It was situated at Janssen’s existing Ringaskiddy Biologics Facility, which had been in operation for approximately 10 years. The project had 5 key goals, which were:

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

The team was ultimately able to deliver on all 5 goals through partnership, teamwork, out-of-the-box thinking, and remaining focused on the end goal to get medicines to our patients.

With the assistance of Project Management Group (PMG) as designer and John Sisk & Sons as builder, the team was able to construct 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.

Janssen, PMG, and Sisk worked as an integrated team throughout the project in decision making to ensure the workers were focused on safety, compliance, and schedule always. The team overcame many issues during the more than 3 years of execution, but the main challenge was to keep the project proceeding forward during the COVID pandemic, which happened as we completed construction and started in full commissioning. Despite this, because of the teamwork approach, the project timeline was not affected.

To ensure flawless execution and start-up, Janssen hired many of the future operators and technicians for the facility early for offsite training and they assisted on commissioning & qualification activities. This ensured smooth operational startup and the ability to begin the ramp up to full utilization.

  • Project Execution -  Janssen Sciences
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For these reasons, the Janssen Science Ireland BioCork2 Project is recognized with the 2021 ISPE FOYA “Project Execution” Category Award.

Supply Partners

Manufacturer/Owner Name - Janssen Sciences Ireland (JSI)
Engineer/Architect (A&E) – PM Group
Construction Manager – John Sisk & Sons
Main/General Contractor - John Sisk & Sons
Piping Subcontractor - Radley Engineering
HVAC Subcontractor - Kirby Engineering & Construction
Automation and Control Supplier - Zenith Technologies, a Cognizant Company
Major Equipment Suppliers/Contractors:

  • Bioreactors – ABEC
  • Clean Steam Generators – Stilmas
  • Electrical and Instrumentation – STS Group
  • Clean Process Piping – Jones Engineering