Southern Indiana Life Sciences Training Institute

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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

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The State of Indiana and the city of Bloomington
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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

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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

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Biotech Companies in South Central Indiana

• Contract Biomanufacturing
• Medical Device Manufacturing

BioConvergenceTM
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Ivy Tech Community College Bloomington Indiana

• Community College System in Indiana
• 14 Regional Campuses with about 100,000
  students
• Bloomington Campus
• 14th regional campus

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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

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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

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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)

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Southern Indiana Life Sciences Training Institute
Project at ITCC Bloomington
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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

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Southern Indiana Life Sciences Training Institute
Project at ITCC Bloomington
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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

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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

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Biomanufacturing Pilot Plant

• Biomanufacturing Pilot Plant
• cGMP standard?
• Advisory boards strong recommendation
• Too much regulatory burden for an
• academic program to maintain

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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

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Biomanufacturing Pilot Plant

• Limited access for trainees

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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

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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

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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.