Biomanufacturing

A state-of-the-art biomanufacturing training facility is yet another key component of the workforce development and service strategies of the JMU Center for 21st Century Manufacturing. Since biotechnology is a relatively new technology, there is only a very small pool of experienced people at the present with the skills needed for biomanufacturing and more importantly, there is no academic program anywhere in the world that provides hands-on experience in cGMP biomanufacturing. The term "cGMP" refers to "current Good Manufacturing Practices," the set regulations and guidelines established by the FDA for the design and operation of manufacturing facilities of pharmaceuticals and medical devices. The facility will focus on workforce skills required for the design and management of biopharmaceutical manufacturing facilities of the future.

As envisioned, the facility would have a production platform with bioreactors capable of producing live cells containing genetically engineered DNA molecules that are expressing foreign proteins. Coupled to the bioreactors will be sophisticated purification systems capable of producing highly purified biomolecules comparable to biopharmaceutical products currently in clinical trials or on the market. The production platform and surrounding shell will be designed and operated according to cGMP regulations and guidelines. The facility would meet FDAs standards for validation in water, air, containment, sterility, and environmental release. In support of the facility would be a media prep room with an autoclave, an analytical lab for quality assurance (QA) and quality control (QC), and a research lab for creating genetically engineered cell lines. The entire shell and production platform would be interfaced with computer systems to enable monitoring, documentation, production control, and some automation.

The proposed biomanufacturing facility addresses the need for technologists who will design, build and manage biopharmaceutical manufacturing facilities of the future. The facility will also serve the training needs of future regulators who develop and enforce federal guidelines governing these processes. Another facet of biomanufacturing the facility will serve is the need for tracking and validating the facilities and biotechnology products of the future. At the present, there is a shortage of experienced people with such specialized skills and hands-on experience required for biomanufacturing and for compliance with cGMP rules and guidelines.

The computer and management of information systems are an integral part of biomanufacturing. Highly skilled people are needed to monitor, document and manage the production process as well as manage the quality assurance and quality control aspects of biomanufacturing. The JMU Center of 21st Century Manufacturing will have the expertise in these areas and will collaborate with industry and the FDA to create a comprehensive and relevant training programs. Since the biomanufacturing process requires careful environmental monitoring, the center will address environmental issues and develop appropriate hands-on training programs.


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Last update: May 19, 1999.