southern indiana life sciences training institute sengyong lee ph.d. associate professor/program...
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Southern Indiana Life Sciences Training Institute
Sengyong Lee Ph.D.Associate Professor/Program ChairIvy Tech Community CollegeBloomington, IN 47404
BIO 2007
The State of Indiana and the city of Bloomington
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 2003Skills 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 development1,500 new jobs in next five years – by BLSPBut limited training resources
A new Life Sciences Training Institute 25,000 ft2, three classrooms, four labs, a training suite & officesExpected to be completed in 2008
Funding Sources$5 million from the local County GovernmentITCC 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 TopicsBMTC, Aseptic Processing, Gowning, Metrology, Documentation, Environment Monitoring, Equipment operation, etc
Biomanufacturing Process Simulation (Pilot Plant) Contract manufacturing serviceTraining & 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
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
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.