UMBI And Parenteral Drug Association Join Forces To Provide Good Manufacturing Practices Training Program

Rockville, MD- In an effort to foster workforce training and education programs, the University of Maryland Biotechnology Institute (UMBI) and the Parenteral Drug Association (PDA) have entered into an agreement to develop a joint Good Manufacturing Practices (GMP) Training Program. This new, cutting edge GMP Training and Biomanufacturing Program will be located at UMBI’s expanded Shady Grove campus and will provide students and industry employees with the opportunity to gain workforce experience in a fully functional GMP facility. This is the first GMP Training program of its kind in the I-270 Technology Corridor.

“By leveraging the investment of this state-of-the-art GMP facility and our expertise with that of the Parenteral Drug Association, we will move forward quickly to provide hands-on workforce training in the manufacturing of biologicals and expertise in the technical aspects of CGMP operations,” said Dr. Jennie Hunter-Cevera, president of UMBI. “This is a winning combination which will provide Maryland with the ability to meet both industrial and academic training needs.”

UMBI and the PDA will be jointly responsible for the development and conduct of the new training program which will train the present day and future workforce in the manufacturing of licensed pharmaceuticals under GMP conditions. They will also establish an Advisory Committee to assist in the development of training curricula and performance goals and objectives, and will be recruiting members of the biotech community, both academic and industrial, to serve on this committee.

“This agreement will facilitate the industry’s ability to provide hands-on training to students and academics wishing to embark on careers in pharmaceutical sciences and manufacturing,” said Gail Sherman, Vice President of Education, and Director, PDA Training and Research Institute. “Traditionally, PDA provides training to those already in the pharmaceutical and biotechnology industry. This endeavor gives us the opportunity to provide the local industry the expertise most needed when recruiting for positions within their companies and retaining existing staff.”

“We expect the combination of this new GMP facility and the collaboration we are entering into with the PDA to increase awareness and knowledge of the requirements to produce pharmaceutical products,” said Dr. Daniel Kuebbing, Director of UMBI’s GMP Training and Biomanufacturing Program.

UMBI’s state-of-the-art GMP facility includes: 6,000 square feet of clean rooms, 1,100 square feet of QC labs, 2,000 square feet of wet lab space, and additional support space for storage, change rooms and offices is part of the 140,000 square foot expansion at UMBI Shady Grove.
“By investing in Maryland’s biotech workforce through programs such as the Good Manufacturing Practices training program at UMBI’s Shady Grove campus, we are working to ensure Maryland remains a leader in biotechnology, a critical component of Governor Ehrlich’s vision of technology dominance,” said Maryland Department of Business and Economic Development Secretary Aris Melissaratos.
Home to more than 350 innovative bioscience companies, Maryland has the fourth largest concentration of bioscience activity in the country. In fact, FierceBiotech.com recently identified Maryland as one of the top five regions for biotech innovation. In June 2005, Maryland was recognized by Ernst & Young as one of the top three centers for biodefense in the United States. Maryland was also recently ranked second in the nation by the Milken Institute for biopharmaceutical innovation. Maryland continues to lead the nation in academic and federal research and development dollars per capita. Much of Maryland’s success and competitiveness can be attributed to the State’s significant commitment and long-term investment in bioscience infrastructure — totaling more than $450 million.

For more information on the GMP facility please contact Dr. Kuebbing, Director of UMBI’s GMP Training and Biomanufacturing Program at 240-315-6350, or e-mail him at gmp@umbi.umd.edu. To apply to serve on the Advisory Board please contact Ms. Sherman, Vice President of Education, and Director, PDA Training and Research Institute at 410-455-5981, or e-mail her at sherman@pda.org. Interested parties may also contact Dr. Kuebbing for more information on the Advisory Board.

To read about this story in the Baltimore Business Journal, click HERE or in the Washington Business Journal, click HERE

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About PDA
Connecting People, Science and Regulation
The Parenteral Drug Association (PDA) is a nonprofit international organization and a leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 10,000 members worldwide. More information about PDA is available at www.pda.org.
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About UMBI
UMBI is Maryland's premier biotechnology research institute within the University System of Maryland. It was established in 1985 and is dedicated to putting bioscience at the forefront to meet societal needs. UMBI’s new GMP Training and Biomanufacturing Program will be located at the expanded Shady Grove campus adjacent to the Center for Advanced Research in Biotechnology. The facility will foster the production of biologics under contract for Phase I/II clinical trials under CGMP (Current Good Manufacturing Practices) as regulated by the FDA. The program will also provide process and analytical method development services. The program’s training function will include both workforce training and certificate and degree programs. shadygrove.umbi.umd.edu/gmp or www.umbi.umd.edu

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Celebrating our 20th anniversary year, UMBI is Maryland's premier biotechnology research institute within the University System of Maryland and was established in 1985. The University of Maryland Biotechnology Institute (UMBI) consists of five major research and education centers and is dedicated to advancing the frontiers of biotechnology. UMBI’s centers of research include: CARB, the Center for Advanced Research in Biotechnology located in Rockville; CBR, the Center for Biosystems Research located in College Park; and COMB, the Center of Marine Biotechnology, MBC, the Medical Biotechnology Center, and IHV, the Institute of Human Virology, all located in Baltimore. For more information, visit www.umbi.umd.edu