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.