Paragon (Now Catalent) Case Study

Building Success for Contract Manufacturing

Paragon (Now Catalent) Case Study

Building Success for Contract Manufacturing

Paragon (case study heading image)

Paragon Project Highlights

  • 151,000 sq. ft. Gene Therapy and Vaccine Biomanufacturing Facility
  • Baltimore, MD
  • 2018: Implemented project controls, resource loading, schedule integration, and budget controls
  • 2019: Integrated a CQV program, including utility systems, environmental monitoring, and computer systems
  • 2019: Completed facility start-up
  • Helped Paragon achieve milestones prior to regulatory inspections and reduce regulatory burdens for future changes and repairs
Paragon Bioservices building front
Paragon (case study heading image)

Paragon Project Highlights

  • 151,000 sq. ft. Gene Therapy and Vaccine Biomanufacturing Facility
  • Baltimore, MD
  • 2018: Implemented project controls, resource loading, schedule integration, and budget controls
  • 2019: Integrated a CQV program, including utility systems, environmental monitoring, and computer systems
  • 2019: Completed facility start-up
  • Helped Paragon achieve milestones prior to regulatory inspections and reduce regulatory burdens for future changes and repairs

Driven by two decades of success helping companies develop and manufacture complex biopharmaceuticals, Paragon Bioservices launched a dramatic expansion in 2018: construction of a 151,000 square-foot flexible contract biomanufacturing facility to produce gene therapies, vaccines, and other advanced biologics.

Located near the Baltimore/Washington International Airport, the new GMP facility planned to feature multiple flexible manufacturing suites with single-use systems that can be readily configured for customers’ processes. The facility also designed for state-of-the-art upstream and downstream labs, plus an aseptic fill-finish line.

Paragon soon realized they needed support for construction coordination and CQV program development to achieve their milestone dates to remain on schedule and be ready for regulatory inspections. So, Paragon turned to ICQ Consultants for assistance.

“We have a ‘build it and they will come’ model, so we began this project with a set of assumptions on design, equipment-set and utility needs. As we have signed up customers to use the space, many of those assumptions have changed to fit the needs of the customers. So, we have had to be very dynamic in our approach.”

Chris Holmes, Vice President of Facilities and Engineering, Paragon Bioservices

“I’ve worked with many other firms and I have never seen one as flexible, creative or able to bring on additional staff as our needs evolve, like ICQ. Mike Bogan’s years of experience certainly come through and his leadership to drive things that are really important helps us get everyone here at Paragon on board with what needs to happen to stay on track. I have nothing but praise for Mike and the people from ICQ.”

Chris Holmes, Vice President of Facilities and Engineering, Paragon Bioservices

“I’ve worked with many other firms and I have never seen one as flexible, creative or able to bring on additional staff as our needs evolve, like ICQ. Mike Bogan’s years of experience certainly come through and his leadership to drive things that are really important helps us get everyone here at Paragon on board with what needs to happen to stay on track. I have nothing but praise for Mike and the people from ICQ.”

Chris Holmes, Vice President of Facilities and Engineering, Paragon Bioservices

“In our first month on site, we focused on project controls, resource loading, schedule integration, and controlling the budget,” said Michael Bogan, President of ICQ. “We then got to the point where everything was coordinated and we could produce an updated 5,000 item schedule and all our metrics in 15 minutes to track progress.”

Mike led a team of 16 ICQ staffers working full-time at the Paragon site, applying the best practices and innovative strategies for commissioning, qualification, and validation programs that ICQ has developed over many engagements.

For example, ICQ instituted a risk assessment-based change management process for the Paragon facility instead of a traditional change control process. ICQ engineers also established effective system boundaries for the facility, which is essential for limiting the regulatory burden of needed changes or repairs in the future.

After an initial limited engagement, Paragon asked ICQ to lead the entire CQV program, including utility systems, environmental monitoring, integrating computer systems, and facility start-up.

“What we have implemented is a sound platform for Paragon that gets them a more efficient and compliant buildout with programs in place to support ongoing operations.”

Michael Bogan, President, ICQ