Projects

MannKind Corporation

TECHNOSPHERE INSULIN MANUFACTURING FACILITY

 

  • Project Overview
  • Project Details

LOCATION:
Danbury, Connecticut

COMPLETED:
October 2008

TOTAL SQUARE FOOTAGE:
100,000 sq. ft. new construction
20,000 sq. ft. renovation

PROJECT SERVICES:
Construction Management

AWARDS:
The MannKind facility is the first project to ever receive ISPE’s Facility of the Year awards in two categories—Equipment Innovation and Process Innovation Categories for the 2010 Facility of the Year Awards program.

Torcon was the Construction Manager on MannKind Corporation’s Technosphere Insulin manufacturing plant project. 

The project consisted of interior demolition and renovations to an existing two story production building. Approximately 70,000 sq. ft. of the existing space was renovated to house new manufacturing operations. An attached 12,000 sq. ft. central utility plant was also upgraded with new equipment and services. Renovations occurred within the same building as MannKind’s ongoing clinical manufacturing suite, which remained in operation throughout construction.  Extensive planning and phasing were used to keep these areas cGMP compliant.  

At the same time as the renovation work was proceeding, Torcon built a 180,000 sq. ft. addition to the plant. Two fill and packaging suites with associated support rooms were fit-out as part of this phase of work. Each of the four suites (two finished and two shelled for future) can accommodate three fill/packaging lines. The entire second floor of the new building was fit-out for office, meeting, dining and support operations. The new building also includes 9500 sq. ft. of material and product storage space, most of which is refrigerated.

The project provides space for bulk manufacturing operations with solution prep, formulation, a Cryogranulator, and two lyophilizers for freeze drying bulk product.  Product is then transferred to the packaging building for primary packaging into the cartridges for inhalation.

Utility upgrades encompassed new WFI stills, tanks and distribution loops and clean steam generation and distribution.  New HVAC systems were also installed including new electrical gear, boilers and chillers.

Torcon provided comprehensive preconstruction services including estimating, scheduling and procurement, working closely with the designers and owner as an integrated team. Our team participated in design reviews and made significant value engineering and constructability recommendations.

Work was phased to complete the renovation prior to the new packaging area. This approach permitted commissioning, validation and regulatory review to begin early.

The MannKind facility is the first project ever to receive ISPE’s Facility of the Year awards in two categories.