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Southern Indiana Life Sciences Training Institute. Sengyong Lee Ph.D. Associate Professor/Program Chair Ivy Tech Community College Bloomington, IN 47404 BIO 2007. The State of Indiana and the city of Bloomington. Biotechnology in the State of Indiana.
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Southern Indiana Life Sciences Training Institute Sengyong Lee Ph.D. Associate Professor/Program Chair Ivy Tech Community College Bloomington, IN 47404 BIO 2007
Biotechnology in the State of Indiana • 4.5 percent Life Sciences Job Increases rate • 300,000 direct employees in health Industry • The second-highest concentration of biopharmaceutical jobs in the nation and ranking 8th in the nation in employment in biopharmaceuticals • Ranked 10th in the nation for projected biopharmaceutical job increases from 2004 to 2014 • Top 10 in medical devices manufacturing in the country
South Central Indiana and the city of Bloomington • Major shift from traditional manufacturing to biotech manufacturing • Over 5,000 employees already in biopharmaceutical and medical device industries • New biotechnology programs at IU and ITCC • Strong regional partnership in promoting opportunities in Life Sciences industry and education
Biotech Companies in South Central Indiana • Contract Biomanufacturing • Medical Device Manufacturing BioConvergenceTM
Ivy Tech Community College Bloomington Indiana • Community College System in Indiana 14 Regional Campuses with about 100,000 students • Bloomington Campus 14th regional campus
Biotechnology Program at ITCC • Start up Grant from Lilly Endowment 2003 Skills and Knowledge Standards for Associate Degree in Biotechnology developed by Baxter, Eli Lilly, Roche Diagnostics, IHIF • Six regional campuses offering the new Biotechnology Program 2004 Bloomington, Evansville, Indianapolis, South Bend, Terra Haute, West Lafayette
Biotechnology Program at ITCC Bloomington • AS and AAS Degrees in Biotechnology AS – a degree transfer agreement with Indiana University AAS – technical training • Current Enrollment – 109 students 38 in AS and 71 in AAS • Certificate Programs Biomanufacturing & Medical Device Manufacturing Technician Certificate, BIO-HIRE, etc
Southern Indiana Life Sciences Training Institute Project at ITCC Bloomington • Strong local needs for Biotech workforce development 1,500 new jobs in next five years – by BLSP But limited training resources • A new Life Sciences Training Institute 25,000 ft2,three classrooms, four labs, a training suite & offices Expected to be completed in 2008 • Funding Sources $5 million from the local County Government ITCC Bloomington National Science Foundation (Advance Technology Education)
Southern Indiana Life Sciences Training Institute Project at ITCC Bloomington
Southern Indiana Life Sciences Training Institute Project at ITCC Bloomington • Main Training Spaces Biomanufacturing Pilot Plant – Process Simulation Upstream process lab Downstream process lab QC analytical lab Device & Equipment Training suite
Southern Indiana Life Sciences Training Institute Project at ITCC Bloomington
Southern Indiana Life Sciences Training Institute Project at ITCC Bloomington • Curriculum & Certificates on Specific Topics BMTC, Aseptic Processing, Gowning, Metrology, Documentation, Environment Monitoring, Equipment operation, etc • Biomanufacturing Process Simulation (Pilot Plant) Contract manufacturing service Training & education opportunities using real manufacturing environment
Biomanufacturing Pilot Plant • Small to mid scale biomanufacturing facility; Upstream, downstream, filling, packaging, QA & QC, etc • A full time faculty, a lab assistant, and student interns – in house internship opportunity
Biomanufacturing Pilot Plant Biomanufacturing Pilot Plant cGMP standard? Advisory board’s strong recommendation; Too much regulatory burden for an academic program to maintain
Biomanufacturing Pilot Plant • Biomanufacturing cGMP standard; API manufacturing for market or clinical trials cGMP compliance – FDA ISO 6 Class 1000 cleanroom, Testing & Documentation, etc Tight manufacturing schedule
Biomanufacturing Pilot Plant Limited access for trainees
Biomanufacturing Pilot Plant • cGLP Standard Biomanufacturing Pilot Plant Manufacturing for nonclinical lab study Contract manufacturing services for; Process development, nonclinical studies like agricultural, X-ray crystallography, etc • Reduces the regulatory burden on testing & paper work • Allows better access to trainees
Biomanufacturing Pilot Plant Extra Benefits; • Service learning opportunity; Providing DNA and protein samples to K-12 science labs • K-12 teachers professional development workshop • Career awareness - field trip opportunities for K-12 students
Biomanufacturing Pilot Plant • Collecting data from companies and users • Get hard information on the set up and optimization • Help to replicate in other places & raise awareness of things to think about before starting to build.