MannKind

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, Ms. Byrd 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.

“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,” Ms. Byrd said. “In the end, the biologics manufacturing facility was commissioned and qualified with no issues noted during the FDA inspection.”

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-in to 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,” said Michael Bogan, ICQ president. “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.”