Business Xpansion Journal - November/December 2008

facility in Greenfield to keep a toxicology complex running; economic development officials in Sullivan, Tenn. say GlaxoSmithKline is actively pursuing a buyer to maintain a penicillin and amoxicillin plant that it will be decommissioning. While the community may be losing a business, notes Richard Venable, CEO, NETWORKS-Sullivan Partnership, the new occupant of the facility will have access to a trained workforce.

The Sullivan County region is home to the headquarters for King Pharmaceuticals and Graceway Pharmaceuticals, LLC. The county is ideal not just for the manufacture of pharmaceuticals but also for the distribution of the products, says Jack Lawson, director of economic development, NETWORKS-Sullivan Partnership. For instance, Graceway has manufacturing facilities located throughout North America and is able to tap into the advantages

Sullivan County offers in regard to logistics needs, including Foreign Trade Zone designation status and access to interstates 81 and 26. “We are nine hours from 77 percent of the U.S. population,” Venable says. The community is also within 15 minutes of three lakes, which provide the abundant fresh water that is required by biopharma companies.

What’s more, in addition to the GlaxoSmithKline manufacturing facility, Sullivan County has 600 acres available in industrial and business park acreage. “We have recently purchased 322 acres in Bristol, which includes rail services,” Venable says. “And we have 166 acres of business parks located at the intersection of interstates 81 and 26.”

Moving north to New Jersey, a nascent biopharma cluster is developing in the city of Vineland, where the industry can access state-issued Urban Enterprise Zone status. The community

has also established a fund for economic development which is a revolving loan fund that provides long-term mortgages of up to 20 years at a rate of 5 percent. “What is working to our advantage, even though New Jersey is not the lowest cost state in the country to do business, this 20-year fixed rate mortgage will accept a second lien position, allowing a primary lender in front of us so we can leverage our funds even further,” says Jim Lelli, director of economic development, city of Vineland.

Another property related incentive in Vineland is that the city’s industrial commission buys and builds industrial parks. “We acquire the land, subdivide it, run the infrastructure to the curb, able to keep a lid on prices,” Lelli notes. “We don’t want to compete with commercial developers, but we don’t want the prices to get out of hand.”

Lelli says the land becomes an incentive, at $45,000 an acre with utilities in place, which is quite lower than prices

ENSURING PROPER SET UP OF REGULATED SYSTEMS BY RAY BOUKNIGHT

There are many challenges that pharmaceutical and life sciences companies face when relocating or expanding their research facilities to make sure all the moving pieces are reconnected properly and within strict industry guidelines for validation. There are many things that need to be considered including proper power for the equipment, physical security, HVAC considerations, air cleanliness, separation of processing lines to avoid contamination, easily cleanable floors, walls and ceilings and proper temperature and humidity controls to name only a few. Here are some things to consider during the transfer and installation of regulated systems.

If the systems are already in use, there should be existing documentation that defines the current configuration of the system. This is commonly referred to as Installation Qualification (IQ) documentation. The IQ establishes the documented evidence that the hardware platform and the supporting infrastructure components have been installed according to the manufacturer, vendor or custom-developed installation specifications. It documents verification of how the components of the system were installed, when they were installed, who was responsible for the installation, the qualifications of the installers, and documents specifics regarding the installed components. After installation, a performance qualification should be performed to ensure that a system performs as intended in the specified operating range. This execution process is conducted using a company-specific predefined dataset or actual live data.

If this documentation does not already exist, then an as-is set of documentation should be generated to have evidence of the current configuration for the current processing. This documentation would then be used during the install process for the new location of the equipment. Lastly, there should be Standard Operating Procedures (SOP) that document the everyday processes. The SOPs are designed to support system operating environments and to specify procedures necessary for a system to remain in a validated state. Controls and procedures should (as a minimum) cover the following areas:

* Problem reporting

* Change management/configuration management * Backup/recovery/archiving

* Operating procedures

(system use, system administration)

* Periodic reviews

* Training

* Security administration

* Database administration (where applicable)

There are other validation documents associated with this process. Additional information can be found at www.interphasesystems.com / services_validation.asp.