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North Carolina leads the southeastern United States in research and manufacturing in the pharmaceutical and biotechnology spaces. The state has key manufacturing sites spanning from the mountains to the coastal plain, and ranging from small molecule to complex biotechnologies. What started in the state as typical pharmaceutical production and processing, has developed into advanced biotechnology including tissue, cell, and gene therapies. All of the complex processes rely on advanced aseptic processing to deliver complex, life improving therapies to patients.
A hub for advanced aseptic processing wouldn’t exist without the support of the educational system and statewide institutions that promote, nurture, and cultivate the growth in the industry. North Carolina is the home of the UNC System of colleges and universities and to highly regarded private universities. These educational institutions are key players in the research and in the training of the advanced technical workforce needed to create the products and therapies that are being made in the state. These preeminent universities impart the knowledge and skills to take on the tasks of designing, testing and performing advanced aseptic operations for the many sites in North Carolina and beyond.
A highly skilled and highly knowledgeable workforce fosters the innovation and the development of pharmaceutical and biotechnological processes. For every therapy produced, there is a robust process for its production and that process has to be developed, refined and ultimately perfected by the process engineers and scientists who bear that responsibility. Many of the challenges in advanced aseptic processing are faced head on by the process engineers and the manufacturing scientists at the site of manufacturing. As the process is developed and the refinements take hold, the manufacturing operations team gets involved to ensure that the process is executable. The cooperation between engineering, manufacturing sciences and the operations teams is key to perfecting the process, allowing production of therapies for their patients. One area where the process requires deliberate design and engineering efforts is in product transfers. The seemingly innocuous process of moving product from one vessel or one tank to another can be highly complex when trying to maintain sterility under aseptic practices. An engineer can investigate everything from the vessel design to the connection configuration and the interconnecting tubing that makes the connection. Seems simple but can become very complex as the process engineer navigates through all of the factors, materials and design elements that are involved. Multiply that complexity by the number of actions in an advanced aseptic process and you have a huge effort required to make it possible.
Ultimately, the processing of therapies using advanced aseptic processing principles comes down to knowledge and skill that is applied to the process. The process is the integration of the facility, the process equipment and the skilled workforce that pulls all of that together. The union between those three elements are the basis for successful effective and efficient aseptic processing. Here in North Carolina, we get that and that is why we have so many leaders in the aseptic processing space across this state. It starts with the great educational opportunities here and ends with some of the most technically advanced manufacturing sites on the planet.
