Case Studies
Specialty Operations Solutions has been involved in the design, development and operations of a number of facilities throughout the country. Here are a few examples of our success:
University of Alabama-Birmingham
Making the Transition
The University of Alabama-Birmingham had a modest cell therapy program, providing that service in an outstanding academic clinical setting. In 2004, the school set a goal to establish a world-class cell therapy program. This ambitious endeavor required migrating to a CGMP manufacturing setting and facing the associated regulatory challenges that it would demand.
Contracted for GMP consulting, commissioning and ISO certification, Specialty Operations Solutions is providing the regulatory guide path and hands-on work to get the facility and its unique manufacturing equipment commissioned and qualified.
Through its comprehensive service offerings, SOS is able to provide UAB with fully integrated consulting expertise taking them through the complex process of ensuring that the facility is not only functional for the new processes they would be undertaking – but also that it will be in regulatory compliance for this new area of work.
North Carolina Animal Care Facility
Retrofitting for Success
When the owner of a specialized research facility was looking to maximize the value of an existing facility, they called on SOS to get the building customized and operational for new tenants.
Specialty Operations Solutions helped the property owner find new tenants for an existing space – enabling them to maximize the value of property that otherwise would sit empty. SOS provided solutions that saved time, money and ultimately delivered a functional facility with increased value for the owners and maximum functionality for the new tenants.
The wealth of expertise SOS provided put all parties at ease, providing critical direction on both construction issues and laboratory operations. The result provides both parties continual reassurance that their mutual needs would be met by the dedicated and experienced facility management team of SOS.
Wake Forest University Health Sciences
Balancing Functionality and Financial Viability
When Wake Forest University Health Sciences embarked on building a new research facility, it set out to reach two important objectives. First, to meet the needs of the researchers that would be utilizing the facility. Secondly, to meet those needs in an economically responsible way.
Building an “intense” research facility can be an extremely challenging and financially risky endeavor. Specialty Operations Solutions helped Wake Forest University Health Sciences get the best value for a major investment.
The broad experience of SOS enabled them to evaluate the building from both the operational and architectural view, providing an approach that better involved the users while ensuring commercial viability so that the project could be financed. The end result is a state-of-the-art facility that serves the University’s research needs while maximizing the value of its investment.
Current Projects
Here are a few of our current projects:
Wake Forest Institute of Regenerative Medicine – North Carolina
Programming, design services, project management and commissioning for a 22,000 SF expansion of the Wake Forest University Institute for Regenerative Medicine.
Confidential Client – North Carolina
BOD development, programming, project management, equipment selection, construction management, Quality Control, commissioning and turnover for new, four-floor GLP research animal care facility and drug development & safety center.
Confidential Client - Southeast US
Equipment acquisition, ongoing operations support, contract staffing, and external marketing support for new GLP research animal care facility.
Ohio State University Medical Center - Ohio
Provide a wide variety of services on existing and proposed future dispensing pharmacies operating under USP 797 protocols.
University of Alabama - Birmingham, AL
Provide commissioning and validation services on a new cGMP clinical manufacturing facility.