MannKind Case Study

Getting a New Facility Back on Track

MannKind Case Study

Getting a New Facility Back on Track

MannKind Project Highlights

  • New 240,000 sq. ft. Biomanufacturing Plant
  • Danbury, CT
  • 2007: Assessed issues causing project delays and cost over-runs
  • 2007: Implemented project controls, reporting metrics, and execution plan
  • Took project from behind schedule and over budget to completed with no issues at FDA inspection
MannKind Case Study - Getting a New Facility Back on Track

MannKind Project Highlights

  • New 240,000 sq. ft. Biomanufacturing Plant
  • Danbury, CT
  • 2007: Assessed issues causing project delays and cost over-runs
  • 2007: Implemented project controls, reporting metrics, and execution plan
  • Took project from behind schedule and over budget to completed with no issues at FDA inspection

Growing from a discovery company to a biologics manufacturing company can be a treacherous path. Construction of GMP facilities is often chaotic, with multiple contractors and suppliers involved. Specialized project management focused on quality throughout construction is essential for the successful commissioning and validation of the facility.

This was the situation that MannKind Corp. faced when building its own 240,000 square-foot biomanufacturing plant to make its innovative inhalable insulin product, Afrezza®.

In immediate need of expert validation support, MannKind reached out to ICQ. At the time of ICQ’s involvement, construction of the plant in Danbury, Connecticut was well underway. The building shell was up, utilities were being installed, and equipment was arriving on site. ICQ’s team of validation engineers quickly assessed the issues causing delays and cost over-runs and developed a plan to implement solutions.

“During the new facility build-out we found ourselves behind schedule in completing the validation deliverables and the project was in jeopardy of being severely over budget.”

Kimberly Byrd, Former Associate Director for Validation, MannKind

“ICQ implemented a complete set of project controls that included tools for reporting metrics, determining accurate staffing plans and managing budget estimates, as well as providing an overall execution plan that very quickly turned the project around and enabled my team to get things back on track. In the end, the biologics manufacturing facility was commissioned and qualified with no issues noted during the FDA inspection.”

Kimberly Byrd, Former Associate Director for Validation, MannKind

“ICQ implemented a complete set of project controls that included tools for reporting metrics, determining accurate staffing plans and managing budget estimates, as well as providing an overall execution plan that very quickly turned the project around and enabled my team to get things back on track. In the end, the biologics manufacturing facility was commissioned and qualified with no issues noted during the FDA inspection.”

Kimberly Byrd, Former Associate Director for Validation, MannKind

Building a GMP facility means focusing on the details. Every major biopharma project, whether a brand-new facility or a major renovation, will have some challenges. Leveraging our decades of combined experience over many GMP build-outs helps ICQ teams to plug into a construction project at any stage to solve problems or lead CQV management.

“Our goal is always to help clients solve the challenges in front of them. We operate in an intensely regulated environment, and the fundamental first step for these companies is to have a manufacturing facility that meets all its marks, with rigorous quality management systems in place to maintain equipment and systems in a validated state and to ensure adherence to quality requirements over time.”

Michael Bogan, President, ICQ

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Integrated Commissioning & Qualification Corporation (ICQ) is a leading provider of commissioning, qualification and validation services.

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