What does it take to successfully decommission an operating cGMP manufacturing site and meet surrender plan and lease obligations in the process?
Tons of coordination.
When you have a manufacturing facility producing biological materials you must use extreme attention to detail and coordination, and plan, plan, plan for the facility to close safely and properly.
For Organogenesis, we successfully shutdown their long standing 90,000 square foot facility in Torrey Pines.
16-months of planning went into a phase shutdown process that required coordinating with 40-50 different vendors, consultants, and stakeholders, in order to properly close permits, manage decontamination, logistics, stock transfers, emergency generator and equipment removal, IT and tech transfer, office breakdown, meet lease expectations, and finalize all documentation.
Keys to Intersect’s success include the development and management of a day-to-day coordination schedule, weekly and daily meetings, and tons of communication. We also had amazing help from our friends at Dynamic Space Solutions.
On a side note, we also oversaw the planning, design, and construction of a new state-of-the-art 22,000 square foot lab-office space that houses Organo’s Process Development and Quality Control groups. This space had to be complete to support the facility decommissioning schedule.
Intersect is a key partner in the success of any complicated project. We can bring clarity and structure to the most complex requirements, and through meaningful collaboration, build relationships that last for many years.